Enbrel is a biologic, and a generic biologic that is automatically interchangeable with Enbrel will not likely emerge.
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Congress keeps control over biologic drugs Democrats negotiated the removal of what would have been new, controversial protections for biologic drugs.
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Presumably, these monopoly protections will funnel investment into biologic research and development, leading to a greater number of biologic discoveries over time.
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The institute will also share data, biologic samples generated during completed non-human primate studies and biologic samples generated during its own safety studies.
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In fact, while only 2 percent of the population uses biologic drugs, they account for 40 percent of prescription drug spending in the U.S. A biosimilar, on the other hand, is essentially what its name implies — a highly similar version of a biologic drug that is designed to match the branded originator biologic.
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He is also the coordinator of Patients for Biologic Safety & Access, a coalition of 24 patient advocacy organizations interested in ensuring that patients have access to safe and effective biologic medicines.
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The facial skeleton is a biologic system, undergoing regular remodeling.
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Enbrel is an injected biologic drug made from living cells.
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Remicade and Neupogen are biologic drugs made from living organisms.
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Biogen developed a biologic for people suffering multiple sclerosis relapses.
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The public deserves transparency on the quality of biologic medicines.
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Mark Senak is a consultant for pharmaceutical and biologic companies.
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BIOLOGIC DRUGS The deal removes provisions that required a 10-year exclusivity period for biologic drugs, which U.S. Democrats feared would lead to higher prices for some of the priciest drugs on the market.
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Roche's Herceptin is an injected biologic drug made from living cells.
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New drugs that contain a biologic, for example, would be protected.
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The drug is highly similar to the Amgen biologic Neupogen (filgrastim).
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Later, we'll have all that richness and biologic history to learn from.
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More than 85033,000 drug or biologic clinical trials are registered with ClinicalTrials.
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Such biologic medicines account for a rapidly growing share of drug spending.
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He noted that developing biologic drugs is both costly and time consuming.
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What emerged was the Biologic Preservation Organization, a group made to defend sensates.
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Biologic valves are more prone to deterioration and may require a second operation.
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Over the longer term, younger recipients of a biologic valve also fared worse.
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Unlike traditional drugs, biologic drugs cannot be copied exactly to make generic versions.
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Together, they'll search for evidence of biologic and geologic activity on Mars.[ESA]
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Congress intended exclusivity of these biologic medications for 12 years, not 12 ½ years.
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This provides a potent biologic mixing bowl and natural influenza virus mutation factory.
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So, too, does the attack on biomarker changes as proof of biologic activity.
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Imagine receiving customized nutrition advice based on your personal biologic or genetic profile.
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A biosimilar is a biologic drug that is virtually identical to the reference product.
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The project, called bioLogic, is essentially a "breathable workout suit" covered in small flaps.
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The short-lived bidding war for China Biologic had pitted two state-backed buyers.
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A biosimilar is highly similar to, but not an exact copy of, a biologic.
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Biosimilars are, in effect, generic versions of highly complex (and very expensive) biologic drugs.
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Much like generics, biosimilars offer a lower-priced alternative to brand-name biologic drugs.
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Scaled Biolabs: Scaled Biolabs is accelerating biologic, gene, and cell therapies using smart microfluidic chips.
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And then openings, market openings for digital services, financial services, biologic services is tremendous stuff.
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The big question going forward, Ippolito told me, is how low biologic prices will go.
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Biologic drugs are large molecules made using biological processes, and they tend to be expensive.
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"We don't really know what the underlying biologic mechanism is for this association," Fadelu said.
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It reduced stinging and the amount of drug needed to produce the same biologic effect.
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The company develops and manufactures consumer healthcare-related products, medical devices and pharmaceutical/biologic therapies.
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It is unscientific, shaming and hurtful, and spreads misinformation about a natural, purposeful biologic process.
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Because of this, it is not possible to create exact copies or generic biologic treatments.
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No such biologic agents, nor drugs that attack cancer genes, are approved for pancreatic cancer.
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The Federal Trade Commission (FTC) estimates that biosimilars will cost approximately 30 percent less than brand biologic drugs, and industry estimates suggest competition between brand biologic products and biosimilars could save American taxpayers overall, including the federal government, as much as $250 billion by 2024.
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The drug is a biologic, which are manufactured in living cells and then extracted and purified.
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After that, the original biologic drugs would only be covered for those indications under exceptional circumstances.
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This new biologic targets certain functioning of the immune system to keep it from over-reacting.
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Once Wade began receiving her infusions of a biologic drug called Remicade, the Crohn's became manageable.
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Rheumatoid arthritis drug Remicade has been under pressure from biosimilars, or generic versions of biologic drugs.
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Biologic drugs have allowed for great advances in the treatment of complex, chronic and rare diseases.
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Many of the medicines in Part B are high-cost biologic drugs made from living cells.
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Democrats have also expressed concerns about USMCA's impact on prices for certain high-cost biologic medicines.
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Biosimilars, as their name suggests, are similar to their originator biologic, but they are not generics.
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TPP would create five- to eight-year data protections for biologic products in all member countries.
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The drug, Siliq, is the lowest priced injectable biologic psoriasis treatment currently on the market, Valeant said.
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Siliq is the lowest priced injectable biologic psoriasis treatment currently on the market, Valeant said on Friday.
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New devices are being created every day to incorporate smartphones into collecting important medical and biologic data.
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The death rate was 253.7 percent with a biologic valve versus 22013 percent with a mechanical one.
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However, the complexity in the development and manufacture of biologic drugs means that they are typically costly.
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This framework has helped make biologic medicines in the United States among the safest in the world.
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Biosimilars are generic versions of biologic medicines, which are complex and aren't easily replicable like typical drugs.
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But they continue to discuss issues, including China's cloud computing regulations and its protections for biologic drugs.
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Despite the potential biologic hazard, there are no standards for processing placenta for human consumption via encapsulation.
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Assigning each biosimilar its own unique reimbursement code creates a robust, competitive biologic market which benefits patients.
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Countries that protect intellectual property can expect biologic prices in many cases to exceed $45,000 per year.
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Facial aging is a normal biologic process and differences exist based on gender, geography, exposures, disease, and upkeep.
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Biosimilars are biologic drugs that are usually lower-cost versions of some of the world's best-selling therapies.
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And now Democrats are homing in on the deal's protections for biologic drugs, according to the Associated Press.
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So far, treatments include biologic injections (which are expensive and invasive) and topical creams (which don't always work).
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Their offers have put China Biologic at the center of a bidding war involving two state-backed buyers.
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Panelists also urged greater education of the public about biosimilars, copies of biologic drugs made from living cells.
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ACA reforms to the Indian Health Service or provisions for FDA approval of generic biologic drugs would disappear.
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It has been estimated that biosimilar medicine costs on average 30-percent less than the originator biologic medicine.
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Froman said the main outstanding hurdle is the length of intellectual property protections for high-tech biologic medicines.
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Why do we attribute that to sleep when we don't do it to other biologic needs, like thirst?
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NAFTA 6900 also expands the definition of "biologic" so that more drugs are covered by the monopoly period.
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Low-income patients in government plans would pay nothing for generics and biosimilars, copycats of complex biologic drugs.
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It is a biologic drug, meaning that it's produced in living cells, which is a difficult manufacturing process.
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Dupixent is now the first biologic medicine approved in the EU to treat these patients, according to the companies.
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China Biologic makes and sells plasma products, such as human immunoglobin, to prevent diseases such as measles and hepatitis.
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Eli Lilly, for example, is behind Portrazza, the first biologic approved to treat a common type of lung cancer.
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Patents on the diabetes drugs Humalog and Humulin have already expired, but they are biologic drugs without generic competitors.
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Biosimilars are medicines deemed highly similar to an original drug and are seen as cheaper alternatives to biologic products.
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He currently serves as an independent board member of US BIOLOGIC, which is developing a novel wildlife Lyme vaccine.
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Biosimilars are lowering the price of biologics in the US, being priced 35 percent lower than the originator biologic.
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The authors found no evidence that developing biologic drugs was more time-intensive than traditional small-molecule (biosimilar) medicines.
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Biosimilars aim to copy biologic products, which are made inside living cells, but they can never be exact duplicates.
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"We're hopeful that he can, that it is completely treatable with the biologic prescription the doctors recommended," Eppler said.
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Biologic drugs such as Neulasta are made inside living cells, and it is impossible to make exact generic copies.
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Many patients using biologic treatments live with chronic and rare diseases that may only effectively be treated by biologics.
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China Biologic makes and sells plasma products such as human immunoglobin to prevent diseases such as measles and hepatitis.
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In previous studies, PMS has been tenuously connected to ovarian hormone secretion, and even biologic, social, demographic, and behavioral factors.
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This includes extensions of drug patent monopolies beyond 20 years, guaranteed additional exclusive marketing rights for biologic drugs, and more.
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Pfizer said it supported a well-controlled switch from a reference biologic drug to a biosimilar in an approved indication.
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NewLink Genetics' portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications.
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Similarly, with mitral valves, the share of biologic prostheses went from 16.8 percent in 1996 to 53.7 percent in 2013.
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Fortunately, breakthroughs in new medications, particularly biologic drugs, are helping people with these conditions lead healthier and more productive lives.
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It is also a biologic, which typically faces patent slopes as opposed to patent cliffs like traditional, small-molecule drugs.
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It created a pathway for federal approval of biosimilars, which are near-copies of biologic drugs, made from living cells.
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The United States currently grants data exclusivity, a type of intellectual property protection, to new biologic products for 12 years.
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Every eight weeks, she takes the two with Crohn's to a hospital for infusions of Remicade, an expensive biologic drug.
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The owners of branded biologic drugs have been known to put out misleading advertising that casts doubt on the copycats' safety.
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The risk of bleeding was lower among mitral valve patients with a biologic valve if they were aged 50 to 83.
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Founded in 2002, China Biologic engages in the collection, research and development, manufacturing, and commercialization of human plasma-based biopharmaceutical products.
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Since 2014, biologic drugs account for nearly all of the growth in net drug spending: 93 percent of it, in fact.
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As a result, patients and physicians can expect the same clinical results when using a biosimilar or the biologic reference drug.
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Yes, but: Some experts are arguing that that's not enough, and that biosimilars aren't the best way to control biologic prices.
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A harbor pilot who had boarded the vessel wearing biologic protective gear navigated the boat at high tide through the bay.
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Drugs approved to be imported from Canada would exclude many prescribed drugs, such as biologic drugs, controlled substances, and intravenous drugs.
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Data exclusivity prevents firms that create similar molecules called biosimilars from using data from the original biologic to enter the market.
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More quietly, some patients are facing higher costs for everyday drugs like insulin as well as for costly, complex biologic drugs.
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Some also have raised concerns that a 10-year period of data exclusivity for biologic pharmaceutical makers will raise U.S. drug prices.
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Let me give you one example of just how hard it is to take a biologic from a lab into the marketplace.
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The rise of personalized medicine, especially through highly complex biologic drugs, has made it easier to target products toward specific rare conditions.
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In addition to gel injections they include steroids, as well as emerging biologic injections like stem cell and platelet-rich plasma shots.
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It also states that a biosimilar maker must give the original biologic drug maker 180 days' notice before launching its copycat version.
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It is clear that price gouging is not limited to newly developed or expensive biologic/designer drugs even the price of insulin.
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Among these include standards addressing the labeling of biosimilars and the parameters in which they can be considered "interchangeable" with a biologic.
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Even though only 2 percent of patients in the U.S. use biologic medicines, they represent 40 percent of total prescribing drug expenditure.
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"There are economics, social, environmental, biologic, genetic, behavioral and health care factors that all contribute to disparities in this country," Howell said.
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Would she ever again hear Anahah's laughter over the improbable genesis of multicellular biologic life through the sexual reproduction of slime molds?
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But we may share some biologic similarities with species like oldfield mice, making research like Dr. Hoekstra's a source of potential clues.
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On the losing end of this requirement are impoverished citizens of developing nations, who would see the cost of biologic medicines soar.
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The mission: to search for evidence of biologic and geologic activity on Mars and to test technologies for the second phase of ExoMars.
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After the completion of the deal, Centurium, CITIC, Hillhouse and PWM will own a combined stake of about 37 percent in China Biologic.
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The introduction of biologic products to treat chronic and rare diseases has been the most significant advancement in patient care in recent decades.
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In rheumatology, just as in other disciplines, we consider very expensive biologic medications for treatment, especially for rare and hard-to-treat diseases.
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Essentially, the intent of both bills is to improve transparency for generic drug and biologic manufacturers, respectively, over access to patents and exclusivity.
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The panel voted 20-O that there is no clinically meaningful difference between Novartis's drug, a biologic made of living cells, and Enbrel.
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House Democrats are taking a victory lap after getting rid of controversial protections for biologic drugs in the new North American trade agreement.
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Importantly, many of the most expensive drugs are excluded from this proposal, including insulin and biologic drugs like Humira and other injectable drugs.
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The biologic therapy, delivered as a shot, targets two key proteins that may play a central role in the inflammation underlying certain allergic diseases.
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Members have also taken issue with the agreement's pharmaceutical provisions, which would enshrine protections for biologic drugmakers by preventing cheaper alternatives for a decade.
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Copies of biologic products cannot easily be replicated and are known as biosimilar, not generic, because they are similar, not identical, to the original.
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From the most basic form of biologic necessity, to neurochemical, social, even existential interactions, eating is rarely as simple an act as it seems.
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"We ask you to stand by your previous support for reducing U.S. market exclusivity to seven years for high-cost biologic medicines," they wrote.
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"We don't presume to know the biologic effects, but artificially-sweetened beverages seem to account for at least part of the difference," Fuchs said.
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The biologic and genetic transmission of genes causing addiction coupled with aversive childhood experiences as well as inadequate mental health services will perpetuate dependence.
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So I think you're going to see less of that in the biologic space than we had seen previously in the small molecule space.
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This could include allowing pharmacies to dispense a biosimilar instead of a brand biologic, like they can with generics and traditional brand-name drugs.
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The European Commission approved Regeneron Pharmaceuticals' and Sanofi's key biologic treatment dupilumab for moderate-to-severe atopic dermatitis, the two companies said on Thursday.
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The agreement as designed now sets up a 10-year exclusivity period for biologic drugs, shielding companies from cheaper generic competitors during the period.
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Companies currently submit new product applications to different divisions in the FDA, depending on the whether the product is a drug, device or biologic.
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Now, the administration is reportedly considering scaling back the protections to allow cheaper, generic versions of biologic drugs to come to the market quicker.
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Still, its price is a bit lower than many other commonly used biologic drugs, such as Humira and Enbrel, that treat other skin diseases.
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This increases financial returns for biologic developers, but extending similar standards abroad would make many medicines unaffordable to millions of people throughout the world.
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Fortunately for the one in four adults who have been diagnosed with arthritis, effective treatments – like next-generation biologic and biosimilar therapies – do exist.
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One aims to boost the power of current antibiotics and another uses a new biologic to disable the bacteria's toxins that incapacitate the immune system.
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Other Democrats raised concerns about the prospect for higher drug prices resulting from the USMCA's provision for 10 years of data exclusivity for biologic drugs.
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Details: The U.S. guarantees 12 years of market exclusivity to new biologic drugs, before cheaper quasi-generic competitors known as biosimilars can come to market.
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Many insurance plans require patients to try the brand-name biologic first, and only move to a biosimilar if the first drug fails, Woollett said.
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The drug, Mvasi, belongs to a class of drugs known as "biosimilars" — which are like generic versions of highly complex, and therefore expensive, biologic drugs.
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The discount program includes Lilly products such as Humalog, Basaglar and a long-acting biologic being introduced this month by Lilly and Germany's Boehringer Ingelheim.
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Then participants will also have a complete file on themselves — with all of their electronic health records (EHR) and biologic data all in one place.
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For example, the current list price of Amgen's Neupogen, a biologic that increases white blood cell count during a course of chemotherapy, is roughly $28500,6900.
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Biologic drugs are complex therapies made from living organisms that are far more complicated and more difficult to develop and manufacture than traditional chemical drugs.
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Biologic pharmaceuticals will make up the majority of new drugs, and unfortunately, they are commonly priced at over five figures for a course of treatment.
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House Republican leaders say the length of intellectual property protections for high-tech biologic drugs must be addressed if the White House wants a vote.
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The new trade pact gives biologic drugmakers 10 years of protections against other products that would rely on the data they used to win approval.
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Blood pressure is an exceptionally volatile biologic variable — blood pressure changes in response to activity, stress and your surroundings, like being in a doctor's office.
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With the development of biologic therapies for a variety of rheumatic, oncologic, and other conditions, novel approaches to treating the immune response are now available.
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"But so far the generic biologic drugs (called "biosimilars'' in industry parlance) have failed to lower costs and make the therapies more accessible to patients.
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"Taken in total, the scientific evidence we've evaluated about kratom provides a clear picture of the biologic effect of this substance," Gottlieb said in a statement.
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The speaker said some agricultural and labor provisions needed fixing, and he also believed the deal would reduce intellectual property rights for biologic drugs and pharmaceuticals.
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The American College of Cardiology and the American Heart Association currently recommend mechanical valves for people under age 50 and biologic valves for those over 23.
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Interest in biosimilars has soared in recent years as copies of some of the world's best-selling biologic medicines have hit the market at big discounts.
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The biosimilars law gives the maker of a biologic drug 12 years of exclusive rights before the U.S. Food and Drug Administration can approve a biosimilar.
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Amgen's biologic cancer drug, Neupogen, was first licensed in 1991 and Sandoz argued skipping the patent dance allowed Amgen to move to inevitable patent litigation sooner.
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The U.S. Food and Drug Administration on Monday approved Sanofi SA's Admelog as the first follow-on biologic version of Lilly's top-selling insulin product, Humalog.
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Treatment in the first year will cost $38,000, as more doses are needed, which AstraZeneca said was in line with competing biologic drugs in severe asthma.
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A biologic mechanism in yeast cells may explain the relationship between sugar and malignant tumors, according to a recent study published in the journal Nature Communications.
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Biologic drugs are made from living organisms rather than synthetic chemicals and have been used to treat diseases including diabetes, multiple sclerosis, rheumatoid arthritis and cancer.
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They added that they secured one of their biggest USMCA priorities — scrapping a provision shielding so-called biologic drugs from cheaper generic competitors for 10 years.
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Eli Lilly & Co's Lantus follow-on biologic, Basaglar, won tentative FDA approval in August 2014 but litigation brought by Sanofi delayed final approval to December 2016.
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It is also difficult to imagine that countries such as Malaysia will see large improvements in their biologic industry if they adopt more stringent IP protections.
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Biotechnology firm China Biologic jumped 20.6 percent after Chinese investment company CITIC Capital Holdings offered to buy it in a deal valuing the company at $3.65 billion.
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Li had led investments for Warburg in China's top car rental service provider CAR Inc, medical devices maker Lepu Medical Technology and biotech firm China Biologic Products.
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"I, for one, am highly skeptical, mainly because it makes little biologic sense," says Morton Tavel, clinical professor emeritus of medicine at Indiana University School of Medicine.
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Why it matters: Deals like this are part of the reason biosimilars — envisioned, roughly, as generic versions of complex and pricy biologic drugs — aren't gaining a foothold.
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In the 53 to 25 age group, the death rate at 28 years was 22017 percent with a biologic valve and 27.1 percent with a mechanical valve.
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The new trade deal has received a cool reception in the Democratic-controlled House of Representatives because of its provisions on labor, biologic drugs and other matters.
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Junshi Biosciences has a pipeline of 13 biologic drug candidates including immuno-oncology drugs and drugs targeting metabolic and inflammation or autoimmune diseases, its draft prospectus showed.
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But the ACA did not seek to address that, except for one provision that sought to facilitate generic copies of some of the most expensive biologic medications.
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RMAT is a new approval pathway for biologic therapies, and a key policy I helped craft within the 21st Century Cures Act signed into law in 2016.
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Historically, biologics have enjoyed long market life because there was no approval pathway for biosimilars or follow-on biologics, that are copies of an originator biologic medicine.
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Interchangeability ultimately could set the terms for when pharmacists and drug plans can substitute a biosimilar for an original biologic without the involvement of physicians and patients.
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A critical patient protection in the draft interchangeability guidance involves switching studies to confirm the safety and efficacy of alternating between a biosimilar and its originator biologic.
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We have an opportunity to build upon the infrastructure that has been put in place and continue strengthening our capabilities to meet these and other biologic threats.
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Biotechnology firm China Biologic gained 21 percent after Chinese investment giant CITIC Capital Holdings offered to buy it in a deal valuing the company at $3.65 billion.
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Depending on the complexity of the procedure, we wouldn't emerge from the O.R. for hours, biologic needs such as going to the bathroom or eating be damned.
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Such practices typically involve biologic drugs, medicines that come from living cells containing proteins and other materials that can treat diseases such as cancer or rheumatoid arthritis.
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As a biologic therapy, Fitch expects that when biosimilar competitors arrive, Orencia will experience more gradual market share losses than a small molecule drug facing generic competition.
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This is great news, as the U.S. lags behind other countries when it comes to approving and using biosimilars, which are highly similar copies of biologic drugs.
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Merck's Lantus follow-on biologic, called Lusduna Nexvue, is being developed with funding from South Korea's Samsung Bioepis, and delivers insulin in a pre-filled dosing device.
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FDA's soft endorsement of the switching of non-interchangeable biologic treatments as well as weighing cost benefits goes against critical patient protections provided for in the BPCIA.
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A biosimilar is an FDA-approved highly similar version of a branded biologic prescription drug that has no clinically meaningful differences in terms of safety and effectiveness.
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Biotechnology firm China Biologic jumped 21.1 percent after Chinese investment company CITIC Capital Holdings offered to buy it in a deal valuing the company at $3.65 billion.
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The Antiquities Act allows the president to proclaim a national monument -- setting aside lands to protect and conserve our nation's most spectacular historic, cultural, biologic, and aesthetic resources.
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There are biologic factors and psychological factors and women deserve treatment options and to be able to talk to their doctor about what's the best option for them.
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In fact, the length of telomeres showed that adults with high levels of weekly activity had almost 9 years less biologic aging compared to those who were sedentary.
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Specialty drugs for cancer, hepatitis C and rare diseases — many of them injected biologic drugs, which are produced inside cells rather than by mixing chemicals — drove the increase.
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In the 50- to 69-year-old patients, the added risk associated with a biologic valve was not as high while in older patients there was no difference.
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That's because a provision of the proposed agreement would increase the monopoly period for certain high-priced brand name biologic medicines while banning competition from lower-priced alternatives.
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Perhaps most significantly, they would provide protections for the U.S. scientists who are discovering miracle biologic drugs that are curing some of the most formidable illnesses we face.
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Last year, Gottlieb's first leading the agency, the FDA approved a record number of generic drugs and a handful of biosimilars, or copycat versions of complex, biologic drugs.
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Biosimilars are only labeled as interchangeable by the FDA after they have been proven to produce the same treatment result as their originator biologic in any given patient.
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According to Federal Drug Administration Commissioner Scott Gottlieb, the anticompetitive tactics used by manufacturers of biologic medicines are one reason market entry of biosimilar medicines is so slow.
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If approved, Nucala - chemically known as Mepolizumab - would be the first targeted biologic therapy for the treatment of severe eosinophilic asthma in pediatric patients in Europe, GSK said.
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As an example of the crucial need for public quality standards for biologic medicines, the United States Pharmacopeia (USP) first began developing public standards for insulin in 1955.
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The company is currently in the clinical stage, moving towards approval as a combination product, meaning the device would sell alongside a specific biologic drug as a package.
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As such, there are limitations associated with the FAERS data, and the data by themselves are not an indicator of the safety profile of the drug or biologic.
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It improved prescription drug coverage for Medicare beneficiaries, and it created a new pathway for the approval of less expensive versions of biologic medicines made from living cells.
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Unlike generic drugs, the biologic infusion and injectable therapies covered under Medicare Part B are extremely complex, and each therapy interacts with different patients' bodies in different ways.
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Driving the news: Democrats and the Trump administration have agreed to a new trade pact among the U.S., Mexico and Canada — without protections for brand-name biologic drugs.
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Junshi Biosciences has a pipeline of 13 biologic drug candidates including immuno-oncology drugs and drugs targeting metabolic and inflammation or autoimmune diseases, according to its draft prospectus.
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They also looked at a biologic marker for allergic activity called the eosinophil count; eosinophils are a type of white blood cell associated with allergies and with asthma.
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But Europe's recent experience with the first wave of biosimilar antibody drugs - the biggest section of the biologic market - has upended expectations, suggesting AbbVie will face fierce competition.
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In an effort to realize cost savings, insurance companies have already indicated their intention to switch stable patients on biologic treatments to biosimilars, regardless of their interchangeable status.
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Now, the administration is reportedly considering scaling back or even eliminating the protections outright to allow cheaper, generic versions of biologic drugs to come to the market quicker.
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Ultimately, US negotiators didn't get what they wanted; the final text of the TPP requires countries to provide five to eight years of data exclusivity for biologic drugs.
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Shanghai-based Junshi Biosciences has a pipeline of 13 biologic drug candidates, including immuno-oncology drugs and drugs targeting metabolic and inflammation or autoimmune diseases, its listing prospectus showed.
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Meanwhile, competition for biologic drugs is just beginning in the U.S., and those versions are only expected to cost 20 percent to 40 percent less than the original drug.
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Biologic manufacturers already have 85033 years of market exclusivity, and Sandoz argued that the ruling essentially gave Amgen an additional six months, which could cost them millions in sales.
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The investment firm CITIC's wholly owned unit, CCRE Holdings Ltd, made a cash offer in June to buy China Biologic shares for $110 apiece, valuing it at $3.65 billion.
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China Biologic said the consortium's offer was not in the "best interests of the company and its shareholders as it did not reflect the intrinsic value of the company".
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She adds that the Biologics Price Competition and Innovation Act that speeds licensing for biologic drugs similar to those that already exist was a step in the right direction.
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But Europe's recent experience with the first wave of biosimilar antibody drugs - the biggest section of the biologic market - has upended expectations, suggesting AbbVie won't have an easy ride.
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Biologic medications ("biologics") have been described as miraculous given their potential to help patients suffering from a myriad of serious diseases in ways more traditional small molecule medicines cannot.
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That last provision will grant longer protections to American biologic drugs, against biosimilar competitors, and it will probably raise the profits of those drugmakers when they sell in Canada.
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Apart from one biosimilar product commercially launched in China, its drug portfolio covers over 20 biologic candidates in various stages of clinical development, according to its updated IPO prospectus.
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William Hulse will join MiMedx, which sells biologic products including skin grafts and amniotic fluid, as general counsel and secretary on December 2, the company said in a statement.
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As The Times reported in March, the agreement gives biologic drugmakers 10 years of protections against other products that would rely on the data they used to win approval.
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In addition, the U.S. Supreme Court cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling on Monday.
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The proposal would cut patent protections to five years, rather than the current 10 years, and allow cheaper generic versions of biologic drugs to come to market more quickly.
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The ruling in the case, due by the end of June, could determine how quickly patients have access to near-copies of biologic drugs called biosimilars at potentially cheaper prices.
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Under the existing review system, companies submit products to different divisions of the agency depending on whether it is a drug, device or biologic, a drug made from living cells.
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The Trump administration's new trade deal with Canada and Mexico includes a big win for pharmaceutical companies and Republicans — a provision to protect biologic drugs from competition for 10 years.
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The draft would also aim to speed the introduction of lower-priced generic drugs and drugs known as "biosimilars," which are less expensive versions of costly and complex biologic medications.
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He declined to go into details on pricing but said discounts for biosimilar Humira were likely to be "in the range" of other biologic drug copies already launched in Europe.
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The Patent Trial and Appeal Board on Thursday invalidated all claims of a patent that Amgen has accused Sanofi-Aventis and Regeneron Pharmaceuticals of infringing with their breakthrough biologic Dupixent.
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Copies of biologic drugs, known as biosimilars, are not as easy to produce as normal generic drugs, and AbbVie's aggressive patent strategy has allowed it to further push off rivals.
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The law also improved prescription drug coverage for Medicare beneficiaries, and created a new pathway for the approval of less expensive versions of advanced "biologic" medicines made from living cells.
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Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.
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The ruling has major implications for the pharmaceutical sector because it will dictate how long brand-name makers of biologic drugs can keep near-copies, called biosimilars, off the market.
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The decision has major implications for the pharmaceutical industry because it will dictate how long brand-name makers of biologic drugs can keep near-copies, called biosimilars, off the market.
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They were also able to strip USMCA of a measure to lock in 10 years of market exclusivity for biologic drugs, arguing the provision would inflate high prescription drug prices.
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LONDON (Reuters) - AstraZeneca's said its first respiratory biologic medicine Fasenra failed to meet its target in a clinical trial treating patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
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By the numbers: 6 of the 8 best-selling biologic drugs in 2017 have orphan approvals, and 3 — Humira, Rituxan and Avastin — still have extra exclusivity for some of those uses.
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The agency is also attempting to implement sweeping new regulations to improve food safety, and has begun to tackle the approval process for biosimilars, which are cheaper versions of biologic drugs.
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Besides Luckin, Centurium's portfolio firms include Keking, an online logistics services provider, China Biologic Products , a biopharmaceutical firm which makes and sells plasma products, and online education platform Happy Kids Education.
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The purpose of this research would be "to investigate dose thresholds, contributing nutrients and biologic mechanisms of prenatal vitamins, and to inform public health recommendations for ASD prevention in affected families."
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Health-care providers and patients trust the biologic medications they prescribe and use because they have gone through a proven system where public quality standards are foundational to ensuring their quality.
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Enable Injections is hoping to get a piece of the expected $400 billion market for biologic drugs, or treatments made from living organisms, by revolutionizing how patients take the advanced medications.
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SunTrust also points to Biogen's strength in biosimilars, which are generic versions of biologic medicines used to treat illnesses like cancer and autoimmune diseases, as well as growth opportunities in China.
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On Tuesday, vaccine producer CanSino Biologic said it had started looking for volunteers to take part in a six-month clinical trial of the treatment it was developing with the academy.
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Besides Luckin, Centurium's portfolio firms include Keking, an online logistics services provider, China Biologic Products, a biopharmaceutical firm which makes and sells plasma products, and online education platform Happy Kids Education.
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They also got the Trump administration to drop a provision establishing a 10-year protection period for biologic drugs, which opponents say would have allowed drug companies to keep prices high.
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In addition, certain obligations the United States had pushed for, such as broad investor-state dispute settlement rules and stronger protections for biologic drugs, were suspended in whole or in part.
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The FDA is also attempting to implement sweeping new regulations to improve food safety and has begun to tackle the approval process for biosimilars, which are cheaper versions of biologic drugs.
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There is absolutely no need to repeat that information with a comment on the label that the new product was approved to be a biosimilar to its respective brand-name biologic.
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For more click * Novartis said its proposed biosimilar adalimumab matches the reference biologic Humira, one of the world's best-selling medicines, in terms of efficacy and safety in a long-term study.
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The deal sets a 232.4-year period of protection for biologic drugs, a class that includes many of the world's top-selling drugs like rheumatoid arthritis treatment Humira and cancer drug Avastin.
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"In some instances, like Neulasta, the original biologic product may be the lowest cost option as a result of our ability to drive down pharmaceutical manufacturers' prices," United said in a statement.
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Newer, more complex biologic drugs don't have traditional generic versions, but "biosimilars" were designed to fill the same purpose — introducing a nearly identical product, a few years later, with a lower price.
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Provided an easier pathway to FDA approval for "biosimilar" drugs that are close or equivalent in structure to biologic drugs like vaccines, insulin, and human growth hormones that are already FDA-approved.
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The drug, Benlysta, is a biologic, which means it was made in a living organism rather than chemically, and works by specifically targeting overactive antibodies rather than suppressing the entire immune system.
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The Japanese company expects the acquisition of the Biogen unit Denmark Manufacturing ApS - equipped with six 15,000 liter bioreactors that make biologic drugs derived from cell culture - to be completed in August.
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N faces a crunch moment in Europe in mid-October when less-expensive copies of its $28-billion-a-year biologic drug Humira – the world's best-selling prescription medicine – hit the market.
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"Biosimilar" medicines are similarly composed drugs that are approved for marketing when presenting data demonstrating that there is no clinically meaningful difference in their safety, quality and efficacy from the original biologic.
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The company's next significant patent expiry occurs when Orencia (rheumatoid arthritis/12 of total revenues), a biologic, loses patent protection in the U.S. in 2019, Europe in 2017, and Japan in 2018.
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Tuesday's announcements came after several intense days of negotiations with Mexico over proposed changes to clauses concerning steel and aluminum, biologic drugs and internet services, as well as the new labor provisions.
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Democrats also succeeded in pushing the Trump administration to remove a provision establishing a 10-year protection period for biologic drugs, which opponents say would allow drug companies to keep prices high.
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Democrats, led by Ways and Means Chairman Richard Neal, also were able to kill a biologic drugs patent protection provision they argued put the interests of pharmaceutical companies over those of consumers.
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Democrats succeeded in getting the Trump administration to drop a provision establishing a 10-year protection period for biologic drugs, which opponents say would have allowed drug companies to keep prices high.
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Not only do these discounts not extend to biosimilars, under current law it's impossible for biosimilar producers to offer the same discounts that branded biologic makers not only can, but must, offer.
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Earlier this year Oneohtrix Point Never called his work "bacterial," which sorta gets at the spirit of it; his playing it subdivides and consumes the sounds around it in an almost biologic way.
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Tysabri Royalties: Royalty Pharma intends to acquire rights to the royalty stream from the global net sales of Tysabri, a biologic drug that treats symptoms of multiple sclerosis and Crohn's disease, from Perrigo.
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The two Gilead drugs had 2015 worldwide sales of $19.1 billion, mostly in the U.S. That's nearly two-thirds of all revenue for Gilead Sciences, a biologic drugmaker based in Foster City, California.
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The acquisition is "pricey, but important", said Wells Fargo analyst Tim Evans, as it enables Catalent to beef up previously weak areas of manufacturing active ingredients and final dosage forms of biologic drugs.
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Sleep: A basic need "It is believed that sleep is a restorative process and a basic biologic need," said Dr. Neil Kline, a sleep physician, internist and representative of the American Sleep Association.
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"One that most definitely needs to get fixed, and there's no way to fix outside of the agreement, is biologics," he said, referring to biologic drugs, which are therapies derived from living organisms.
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As currently written, NAFTA 220006 requires signatory countries to give pharma corporations at least a 2202-year monopoly period on biologic drugs, which they often price at over $2628,28500 per person per year.
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Toomey predicted that the number of new jobs created over the next six years would be minimal and that eliminating intellectual property protections for biologic medications could hurt innovation in the promising field.
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David Wang, Senior Managing Director at healthcare investor OrbiMed Asia, cites biosimilars - FDA-approved knock-offs of biologic medicines which are made in living cells - as one technology attracting a lot of attention.
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A biosimilar matches the efficacy and safety of an approved biologic (known as the reference medicine) and is able to be brought to market once the reference medicine's 12-year market exclusivity expires.
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LONDON (Reuters) - Europe has approved a fifth copy of AbbVie's $18-billion-a-year biologic drug Humira – the world's best-selling prescription medicine – ramping up competition among makers of less-expensive biotech drugs.
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Democrats also succeeded in getting the Trump administration to drop a provision establishing a 10-year protection period for biologic drugs, which opponents say would have allowed drug companies to keep prices high.
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Francis is wagering biotech copies that work like their forerunners despite slight variations - no biologic drug can be exactly duplicated - will be irresistible for insurers, health care systems and governments aiming to contain costs.
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Many companies are developing a wide range of biosimilar versions of top-selling biologic medicines, including major biotechs like Amgen Inc, which is working on cheaper versions of several of its rivals' blockbuster drugs.
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The partnership will develop novel biologic drugs in "unmet disease areas", Bioepis said in a joint statement with Takeda, adding the two companies will immediately begin working on a treatment for severe acute pancreatitis.
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The worthwhile goal of this new version of the CREATES Act is to prohibit pharmaceutical and biologic companies from engaging in anti-competitive conduct that blocks lower-cost generic drugs from entering the market.
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Some of the steps it outlines are rebate-sharing in Medicare drug plans, promoting generics and copycat version of biologic drugs and requiring drug manufacturers to publish list prices for drugs in television advertisements.
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Most importantly, standards addressing the labeling of biosimilars and the circumstances in which they can be considered interchangeable with a biologic or are able to be substituted for the original treatment must be finalized.
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Biosimilars aim to copy biologic products, which are made inside living cells, but they can never be exact duplicates, so biosimilar manufacturers need to conduct clinical trials to show their products work as intended.
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Obama also proposed lowering the number of years that companies have a monopoly over biologic drugs from 12 years to seven and blocking companies from striking "anti-competitive" deals to restrict access to generics.
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"Currently, manufacturing of biologic drugs in the biopharmaceutical industry relies heavily on large-scale fermentation batches that are frequently monitored offline, to ensure a robust process and consistent quality of product," the paper explains.
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Because they are made in living cells, biosimilars cannot be a perfect copy of their biologic "reference drug," they do provide the same medical benefits to patients with no differences in safety or effectiveness.
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Perhaps more significantly, the drugmakers won an unprecedented, guaranteed 12-year monopoly for biologic drugs — a costly class of new cell-based therapies that are more complicated to manufacture than more familiar chemical drugs.
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The final version of the deal does not include a provision that would have locked in 10 years of patent protection for biologic drugs, which are made from living organisms rather than synthetic chemicals.
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The final version of the deal does not include a provision that would have locked in 85033 years of patent protection for biologic drugs, which are made from living organisms rather than synthetic chemicals.
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"Traditional treatments for psoriasis, such as topical corticosteroids, topical vitamin D analogues, retinoids, and biologic therapies, currently have the most data supporting their use, and therefore, should remain first treatments for psoriasis," Price advised.
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The Food and Drug Administration said last year that biologic drugs account for almost 40 percent of U.S. prescription drug spending, and for 70 percent of the growth in drug spending between 2010 and 2015.
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In the end, it'll be up to insurance companies and providers to decide whether an orphan approval makes a biologic more desirable than a biosimilar, even for the non-orphan uses that drive most sales.
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Susan Collins and a bipartisan group of her colleagues are wading very gently into the debate about drug companies' patent protections, specifically the "thickets" of patents that keep competitors at bay for complex biologic drugs.
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The change: Previously, the FDA's Office of Regulatory Affairs operated an umbrella of five geographical region heads — now, it'll have six product-specific offices instead: pharmaceutical quality, medical devices, tobacco, food, biologic drugs, and research.
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In another aspect on biosimilars, the U.S. Supreme Court could decide by this summer on whether to keep a 180-day waiting period in place before makers of biologic drugs can launch sales after approvals.
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SEOUL (Reuters) - Samsung Bioepis Co Ltd said on Monday it will fund and develop multiple original drugs in partnership with Japan's Takeda Pharmaceutical Co Ltd, expanding its business scope beyond copies of existing biologic drugs.
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Some steps have already been taken to assure safety – Congress established a separate and more rigorous standard for biosimilars that could be substituted for original biologic treatments at the pharmacy level, called the "interchangeability" standard.
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The bill provides for the Health and Human Services assistant secretary for preparedness and response (ASPR) to stockpile medicines, respond to disasters or biologic threats and support new drugs to fight pandemic threats like influenza.
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The provision would represent a shift from providing the public with access to the expectations for a quality biologic medicine, to keeping specifications private between only the manufacturer and the regulator that grants market approval.
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The findings help "strengthen the biologic association" between Zika virus infection and microcephaly, researchers from the Harvard School of Public Health and Massachusetts General Hospital in Boston, wrote in an editorial that accompanied the paper.
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The first is a system engineered to kick out multiple therapeutic proteins in response to programmed (chemical) cues, while the second is a millimeter-scale microfluidics production platform for actually producing the biologic end product.
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There has been more than 700 million patient days of treatment with biosimilars in Europe, and there are no new safety or efficacy concerns that are not already been known from the biologic reference drug.
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The new deal with Mexico and Canada does not include a provision that would have locked in 85033 years of market exclusivity for biologic drugs, which are made from living organisms rather than synthetic chemicals.
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Manufacturers of generic drugs contend that technological advances are reducing the amount of time it takes drug companies to bring new biologic medicines to market, and that lengthy exclusivity periods guarantee high prices for patients.
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They're continuing to innovate and they're investing a lot in R&D...the biosimilar (an almost identical biologic copy of an original drug) is a threat to them and they've just got to work harder.
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The new version of the deal between the US, Mexico and Canada will get rid of controversial protections for biologic drugs entirely, a decision certain to receive criticism from a number of congressional Republicans. Rep.
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U.S. Democratic lawmakers have described as a "giveaway" a provision under USMCA that would grant 10 years of data exclusivity for makers of biologic medicines, arguing that it will lead to higher prices for consumers.
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Some issues were worked out quickly: An agreement to strip out protections for biologic drugs, which opponents say would allow drug companies to keep prices high, was struck in those first few weeks, said Rep.
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With passage of the Biologics Price Competition and Innovation Act (BPCIA), Congress paved the way for a new class of drugs, biosimilars, which have the potential to increase patient access to life-saving biologic treatments.
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He said key elements of the new lower-cost technology include processes that yield a larger number of cells to produce biologic drugs, a smaller footprint that emits less carbon and uses less water and electricity.
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NEW YORK (Reuters) - The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them.
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About one third of patients either do not respond sufficiently or cannot tolerate popular biologic treatments for rheumatoid arthritis, such as AbbVie's Humira, the world's top-selling prescription medicine, creating a need for new therapy options.
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To this end, the National Institutes of Health (NIH) is launching a first-of-its-kind longitudinal study, All of US, to gather biologic, lifestyle and environmental data on one million Americans across the United States.
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He noted that Teva had taken positions "directly opposed to PhRMA views" on patents, the lifeblood of the brand-name pharmaceutical industry, and biosimilars, which are copycat versions of costly biologic drugs made from living organisms.
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According to Thomson Reuters data, analysts expect Dupixent to reach annual sales of 4.7 billion euros by 2023 and Sanofi sees the product spearheading its drive into greater reliance on high-margin biotech, or biologic, drugs.
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In addition AZ's capex remains elevated (plateauing at 10.1% of total product sales in 2016) as the group continues to invest in its Cambridge headquarters and modernise its manufacturing sites with a focus on biologic agents.
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Seemingly 'stupid' biologic organisms are able to perform tasks in aggregate that are staggeringly complex, such as protein folding or the ability of cells to multiply and form complex structures like eyes, hearts, brains, and other organs.
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The drug is also a biologic, which tends to experience more moderate market share losses to biosimilar competition over time, when compared to that of a small-molecule branded drug facing generic competition for the first time.
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The U.S. solicitor general has filed a brief urging the Supreme Court to review and overturn a ruling that prevents drugmakers from selling copycat versions of biologic drugs until at least 180 days after they are approved.
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Medicare Part B spending on prescription drugs has been rising, from $17.6 billion in 2011 to $25.7 billion in 2016 — mostly owing to expensive biologic medicines, some of which cost more than $50,000 per beneficiary per year.
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But U.S. Trade Representative Michael Froman said he is continuing to press the TPP case with individual members and working with Senate Finance Committee Chairman Orrin Hatch to ease his concerns about patent protections for biologic drugs.
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For more news see The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them.
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"We still see a strong overall market share dynamic with Entyvio capturing approximately 25 percent of new biologic starts in (ulcerative colitis) patients in the U.S.," Takeda's Chief Financial Officer James Kehoe said on a conference call.
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WASHINGTON (Reuters) - The U.S. Supreme Court on Monday declined to hear a case over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval before bringing them to the market.
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"Tezepelumab appears to be the broadest and most promising biologic for the treatment of persistent uncontrolled asthma to date," Elisabeth Bel of Amsterdam's Academic Medical Center wrote in an editorial in the New England Journal of Medicine.
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The "complexity and opacity of these schemes" — "these Kabuki drug-pricing constructs" — are creating an "insidious barrier" to the development and marketing of lower-cost copies of complex biologic medicines made from living organisms, Dr. Gottlieb said.
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Other hurdles include intellectual property rights, such as the U.S.-Mexico 10-year data exclusivity for biologic drug makers and extensions of copyright protections to 75 years from 50, all higher thresholds than Canada has previously supported.
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"If it were a military weapon, the response would be to do everything possible to develop countermeasures," he said at the NEJM event, adding that a "sense of urgency is lacking" when it comes to biologic threats.
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Final interchangeability guidance, which will provide direction for when a pharmacist can substitute a biologic with a biosimilar without consent of a doctor, is imminent, with the FDA evaluating comments it received from stakeholders in the spring.
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U.S. regulators in recent years have acted to encourage the launch of "biosimilar" versions of pricey biologic drugs, but drugmakers like Amgen have used litigation to extend patent protections and limit price competition for as long as possible.
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Another technology that is big right now in the United States is BioLogic, developed by researchers at the Massachusetts Institute of Technology who are investigating the use of microorganisms for intelligent fabrics that can respond to the environment.
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LONDON, Sept 20 (Reuters) - Mylan and Fujifilm Kyowa Kirin Biologics said on Thursday they had won European approval to market a cheaper copy of AbbVie's $18-billion-a-year biologic drug Humira, the world's best-selling prescription medicine.
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"Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches we plan in the next four years," Carol Lynch, Sandoz's global head of biopharmaceuticals, said in a statement.
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From a biologic point of view, the answer to this question is an unequivocal No … [T]here is absolutely no difference in the response of the pelvic viscera to effective sexual stimulation, regardless of [where] the stimulation occurs.
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The biologic is being heralded as a major breakthrough for atopic dermatitis because it's the first to treat the underlying causes of the disease in the body, rather than treating the effects of the disease on the skin.
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But FDA said in its guidance that other product identifiers, like NDC numbers, are not routinely recorded in billing and patient records, undermining the ability to track adverse events by biologic products that share the same proper name.
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Mr. Trump is expected to sign the bill reauthorizing user fees to pay for the review of medical devices, brand-name drugs, generic drugs and biosimilars, which are copycat versions of costly biologic drugs made from living organisms.
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While the U.S. Chamber of Commerce has pushed for the deal's ratification, it took issue with the Trump administration removing a provision that protected makers of so-called biologic drugs from generic competitors for at least 10 years.
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Several Democrats said a closed-door meeting between United States Trade Representative Robert Lighthizer and their caucus failed to ease their concerns about the new U.S.-Mexico-Canada Agreement's (USMCA) provisions on labor, biologic drugs and some other issues.
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PwC says more large employers will likely look to boost the use of biosimilars — lower cost versions of biologic drugs, which are complex medications that use parts of tissues, genes and other living organisms to create more targeted treatments.
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Specifically, this provision would make adherence to public quality standards optional for all of lifesaving biologic products, including insulin, jeopardizing medicine uniformity and quality, which threatens patient safety for Americans with conditions as diverse as diabetes, hepatitis and hemophilia.
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Researchers outside the study say the findings represent a major milestone — proof of a biologic concept that opens the door to new ways of treating and preventing cardiovascular disease in people who are still at risk despite standard therapies.
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The U.S. Chamber of Commerce released a statement praising the deal last month that did not mention the biologic provisions, though it later followed up the next day with a second statement noting its objections to those provisions' removal.
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In other words, these cis researchers, funders, and policymakers seem more interested in "curing" or erasing trans people than finding better and cheaper ways of treating them—or anyone else labeled as falling outside the norm of biologic desirability.
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"No matter how good my psychotherapy, how good the relationship, how good their beliefs and values are about sexuality being healthy, there are a huge number of them that I cannot help because there is an underlying biologic issue," she said.
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But it took me a long time to figure out how to tell the difference between people's opinions that they safeguard in the context of their religion versus the biologic facts and how religion has to interface with those realities.
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The Trump administration delivered a big victory for the pharmaceutical industry by insisting on language in the deal that grants biologic drugs patent protection for 10 years, considerably longer than the seven-year exclusivity period favored by the Obama administration.
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Among other protections for Big Pharma, the USMCA would ensure that pharmaceutical companies have at least 220006 years of exclusivity for their biologic medicines in Mexico and Canada before lower-cost, FDA-approved clinically equivalent alternatives known as biosimilars can compete.
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And, we can all work closely to ensure that the framework for biosimilars, safe and effective alternatives to costly brand biologic drugs, expands and expedites patient access, creating a market primed to save anywhere from $44 billion to $250 billion.
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The NAFTA replacement deal would provide 10 years of market exclusivity for biologic drugs, a new class of medicines developed from living organic molecules, rather than chemicals, that are used to treat numerous serious and life-threatening diseases such as cancer.
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As a Midwestern girl who has never clung too closely to gender norms, a tech exec trying hard to build inclusive products, and a mom of two children of different biologic sex, I have to say — it's about damn time.
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Because injectable biologic drugs such as Humira are made in living cells, they cannot be exact replicas of the original medicine, so regulators have come up with the notion of biosimilars - drugs that are similar enough to do the job.
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Top officials from Canada, Mexico and the United States on Tuesday signed a fresh overhaul of a quarter-century-old deal, aiming to improve enforcement of worker rights and hold down prices for biologic drugs by eliminating a patent provision.
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WASHINGTON, April 26 (Reuters) - U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes to bring to the market copycat versions of biologic drugs, expensive medicines that can generate billions of dollars in sales for drug makers.
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During his tenure, Gottlieb advanced a number of prescription drug policies, including to push the FDA to speed up generic drug approvals and use its powers to encourage wider use of biosimilars, or copycat versions of complex and often costly biologic drugs.
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Dupixent is a first-of-its-class biologic treatment for people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical) or who cannot use topical therapies.
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But a controversial provision tucked deep inside the "Lower Health Care Costs Act" currently being considered by the Senate HELP Committee would overturn this system for the biologic medicines our loved ones take every day and present significant risks to patient safety.
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Researchers at MIT have developed a portable system that can produce biologic drugs on-demand, obviating the need for expensive centralized manufacturing and potentially enabling doctors working in remote or developing parts of the world to create biopharmaceuticals that may be otherwise inaccessible.
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These are just five of the breakthroughs from the past decade, which also saw developments in new "biologic" drugs, which contain or are produced from living organisms, advancements in prosthetics, and in a heartwarming twist, a new medicine for a single patient.
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Prosecutors said that in 2015, Petit and Taylor took part in a scheme to inflate reported revenue in order to make it appear that the MiMedx, which sells biologic products including skin grafts and amniotic fluid, had met its public revenue targets.
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In 23, around the time where some of the biologics were just starting to be used, scientists at the DNAX Research Institute in Palo Alto, California were looking to develop a more targeted biologic medication to treat immune disorders like plaque psoriasis.
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"It is our hope that these studies will help healthcare providers and patients have confidence that switching to Zessly or Erelzi will continue to deliver the benefits they are receiving from their existing treatment," said Mark Levick, who heads development of biologic drugs at Sandoz.
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But now, there's new hope for the 31.6 million Americans living with eczema: The FDA has just approved the first biologic to help treat these symptoms for adults with moderate-to-severe atopic dermatitis and for whom topical treatments have been proven a bust.
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Another issue brief released by the same office Tuesday said that Medicare's Part B program, which among other things covers infusible and injectable drug and biologic treatment by doctors, gives physicians "weak incentives" to consider lower-cost drug therapies to effectively treat a patient.
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MEG TIRRELL: One of the things you've been focusing on more recently and when you used some of that language about schemes and sort of a rigged market system has been around biosimilars, these sort of generic versions of biologic often very pricy biotech drugs.
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Today, we face a situation where these medications continue to be outside the reach of patients and providers, and where the need for biologic medications can force a patient to have to make a decision between getting therapy and needing to file for bankruptcy.
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Members of both parties largely celebrated completion of the new USMCA on Tuesday, although it received a lukewarm response from several congressional Republicans who were unhappy that patent protections for biologic drugs, a key priority for the GOP, were removed entirely from the deal.
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The drugs are the clear choice for the most vulnerable groups: people with H.I.V.; people whose immune systems are compromised because they take biologic drugs for Crohn's disease, arthritis or other diseases; and young children and others who share a home with someone infected.
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The drugs are the clear choice for the most vulnerable groups: people with H.I.V.; people whose immune systems are compromised because they take biologic drugs for Crohn's disease, arthritis or other diseases; and young children and others who share a home with someone infected.
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WASHINGTON (Reuters) - The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies.
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Democrats, who control the House of Representatives, have greeted the trade deal coolly due to concerns about the enforceability of new labor provisions that aim to drive up wages in Mexico and concerns that data protections for biologic drug makers could drive up health care costs.
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Among patients previously treated with at least one biologic drug, the common measure of 20 percent relief of signs and symptoms of the arthritis, known as ACR20, was achieved by 55 percent of those who received an infusion of 2 million cells per kilogram of weight.
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TORONTO/MONTREAL (Reuters) - The Canadian province of British Columbia said on Monday that its public drug plan will switch as many as 20,400 patients from three branded biologic drugs to cheap near-copies called biosimilars, saving an estimated C$96.6 million ($71.9 million)over three years.
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The deal scraps the investor-state dispute settlement program that is designed primarily to protect U.S. investors from what they see as the discriminatory regulatory practices of trading partners and eliminates intellectual property protection for makers of biologic drugs, a major revenue source for the pharmaceutical industry.
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More recently, a 2018 study of 67 ultra-marathon runners found that they had 11% longer telomeres (the protective caps on the end of our chromosomes that are a marker of biological aging), which corresponded to a 16.2-year younger biologic age compared with their healthy counterparts.
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WASHINGTON, June 12 (Reuters) - The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies.
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What they're saying: J&J's "strategy could serve as a blueprint for every brand name biologic drug maker seeking to maintain monopoly power and profits indefinitely in the face of competition from a lower-priced biosimilar," the Biosimilars Council wrote in a court filing in support of Pfizer.
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"Adolescents with moderate-to-severe atopic dermatitis in the EU now have an approved biologic medicine that can significantly control persistent, debilitating symptoms such as itch and skin lesions, as well as improve sleep, which is particularly critical during these formative years," said George Yancopoulos, chief scientific officer, Regeneron.
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The institute's inactivated virus vaccine technology, data and biologic samples had been shared with Sanofi at that time with the hope that the company could produce an effective vaccine against the mosquito-borne disease, which can also be sexually transmitted and passed from mother to baby in utero.
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This has resulted in biosimilar manufacturers being required to wait an additional six months following FDA drug approval to access these affordable, life-saving medicines, and is effectively a court-created marketing exclusivity beyond the guaranteed 12-year period of exclusivity a brand biologic already enjoys by statute.
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WASHINGTON/MEXICO CITY, Dec 10 (Reuters) - Top officials from Canada, Mexico and the United States signed a fresh overhaul of a quarter-century-old trade pact on Tuesday that aims to improve enforcement of worker rights and hold down prices for biologic drugs by eliminating a patent provision.
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The Trump administration also got another trade win last week when House Democrats and the AFL-CIO endorsed a newly revised North American trade agreement with Mexico and Canada, after changes were made to toughen labor enforcement provisions and weaken intellectual property protections for life-saving biologic medicine.
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"The safety and efficacy results of this study are very encouraging and suggest that Mesoblast's cell therapy has the potential to fill the major unmet medical need" for patients who cannot take biologic treatments, Dr. Allan Gibofsky, rheumatologist at Hospital for Special Surgery in New York, said in a statement.
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The drug is described as a "peanut-derived investigational biologic oral immunotherapy drug," but the active ingredient is simply defatted peanut flour that is carefully measured and packed into capsules or foil sachets of varying doses that are easily opened so the contents can be mixed into unheated food and consumed.
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The Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategies (REMS) system was created to ensure drug quality and safety, but is often used instead to make it more difficult for generic and biologic manufacturers to enter the marketplace — limiting competition and cost savings while creating drug-specific monopolies.
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"Combining Sanofi's biologic innovations and scientific data with Google's industry-leading capabilities, from cloud computing to state-of-the-art artificial intelligence, we aspire to give people more control over their health and accelerate the discovery of new therapies," said Ameet Nathwani, chief medical officer and executive vice-president, Sanofi.
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"I believe our study, for the first time, definitively shows there is a component of higher A1c that is due to biologic or genetic differences in glucose attaching to the red blood cell," said Dr. Richard Bergenstal, executive director of the International Diabetes Center in Minneapolis and lead author of the study.
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The Food and Drug Administration has approved nine biosimilars, generic versions of biologic medicines, but only three are available in the U.S. Manufacturers are using several schemes to "hamstring biosimilar competition," FDA Commissioner Scott Gottlieb said at the Pharmaceutical Care Management Association's PBM Policy Forum, according to a copy of his prepared remarks.
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I proposed FDA reform that would define four distinct categories of biologic activity that would satisfy the effectiveness requirement, consistent with the Federal Food Drug and Cosmetic Act (FD&C) including: (1) biomarker changes; (2) improvements in clinical signs and symptoms; (85033) disease modification; and/or (4) long term outcomes, including survival.
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Leaders of the United States, Canada, and Mexico signed the initial USMCA agreement more than a year ago, but since then, Democrats controlling the House have pressed for changes to strengthen the enforcement of new labor standards and relax data protections for biologic drugs that they fear will mean higher drug prices.
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In the same brief, filed Wednesday, Acting Solicitor General Ian Gershengorn urged the court to uphold a decision from the U.S. Court of Appeals for the Federal Circuit that a company seeking to make a copycat biologic, called a biosimilar, can opt out of a patent dispute process laid out by the federal biosimilar law.
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The researchers concluded that the case seemed like sexual Zika transmission from the man to the woman, but they weren't sure of the route: "We cannot rule out the possibility that transmission occurred not through semen but through other biologic fluids, such as pre-ejaculate secretions or saliva exchanged through deep kissing," they added.
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In an amicus brief filed Thursday in the U.S. Court of Appeals for the Federal Circuit, the Illinois-based drug company said strong patent protections, including injunctions barring sales in some cases, were needed to promote the development of so-called biologic drugs like Praluent, Amgen's competing drug Repatha and AbbVie's blockbuster arthritis drug Humira.
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The sale, which amounts to around 9 percent of WuXi Biologic shares, will raise up to $565 million at the top end of the indicative price range of HK$40 to HK$41 per share, which represented a discount of between 1.4 percent and 3.8 percent to Wednesday's closing price, the term sheet showed.
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Negotiations between Democrats in the House of Representatives and the United States Trade Representative (USTR) appear to have made substantial progress on key issues where the Democrats seek changes — labor rights, environmental protections, shorter intellectual property protections for biologic drugs, and stronger enforcement mechanisms, especially on labor issues where Democrats worry about Mexico's performance.
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"We believe it's a real game changer for our ability to understand the biologic causes of postpartum depression and postpartum psychosis and to use state of art science to develop innovative treatments, and that's the overall goal," said Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the UNC Center for Women's Mood Disorders.
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The Supreme Court will consider early next month whether to grant a petition for review that would require it to interpret the federal law on copycat biologic drugs for the first time, in a case that involves a bid by Apotex Inc to make biosimilar versions of Amgen Inc's white-blood-cell-boosting drugs Neulasta and Neupogen.
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The erasure of other provisions of Obamacare would rattle the health system, eliminating consumer protections for health insurance customers; increasing the cost of prescription drugs for Medicare beneficiaries; weakening penalties for health care fraud; reshaping government payments to hospitals, doctors and insurance companies; and undermining an approval pathway for generic versions of biologic drugs, among many changes.
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These include a provision requiring at least 10 years of data protections for biologic medicines, a provision requiring patents to be available for new uses of drugs, a provision requiring three years of data protections for clinical information submitted in connection with new uses of previously approved medicines, and a provision that links regulatory approval and patent status.
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To help American patients better handle the expense of biologics, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) as a provision of the American Care Act (ACA.) This provision allowed for the introduction of biosimilars to the prescription drug market under the theory that a biosimilar could provide some of the same medicinal therapies of a biologic for a lower cost.
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Still, the current study results add to evidence that there's no safe amount of cannabis exposure for babies in the womb, said Dr. Nathaniel DeNicola of George Washington University in Washington, D.C. "We have sufficient data and biologic plausibility that marijuana use during pregnancy increases the risk of preterm birth and growth restricted babies," DeNicola, who wasn't involved the study, said by email.
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To help Americans manage the expense of biologics, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) as a provision of the Affordable Care Act (ACA.) This provision allowed for the expedited development and introduction of biosimilars to the prescription drug market because a biosimilar could, in theory, provide some of the same therapeutic benefits of a biologic at a lesser cost.
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Notice, I am not criticizing you outside of your genre; I am not telling you that you are anti-intellectual (afraid of abstract scientific method and the truth it finds), a romantic, unrealistic (you don't realize, for instance, that political action in an industrialized society must be collective; that your "poetic anarchism" is made up of fine, beautiful words, but is impractical by definition in the complex mélange — economic, psychologic, and biologic – of modern society) a poor academic thinker (by academic, I mean using accredited methods of philosophic investigation based on palpable, objective knowledge), etc.
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J.) and Pat ToomeyPatrick (Pat) Joseph ToomeyNSA improperly collected US phone records in October, new documents show Overnight Defense: Pick for South Korean envoy splits with Trump on nuclear threat | McCain blasts move to suspend Korean military exercises | White House defends Trump salute of North Korean general WH backpedals on Trump's 'due process' remark on guns MORE (R-Pa.) spoke out against the removal of the biologic protections at the Senate Finance Committee session on the trade agreement this month, and the Senate Health Committee session to review the deal on Wednesday provides another opportunity for lawmakers to go on record on the issue.
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