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    Biosimilars Forum Seeks More Clarity in FDA Draft Guidance on Biosimilar Interchangeability

    The nonprofit industry group Biosimilars Forum is calling on the US Food and Drug Administration (FDA) to clarify that a demonstration of interchangeability represents a distinct requirement for additional data compared to a demonstration of biosimilarity. The comment, released this week, follows FDA's issuance of draft guidance on biosimilar interchangeability in January and the release of other comments from stakeholders last month, who also sought more clari...
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    Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (2 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Indian Antitrust Watchdog Probes Allegations Roche Tried to Influence Regulators The Indian antitrust watchdog has begun an investigation into allegations Roche tried to influence regulatory agencies and otherwise stop biosimilar copies of Herceptin from gaining market share. Roche is accused of seeking to influence the office of the Drug Controller General of India (...
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    Supreme Court Weighs Biosimilar Patent Dance

    All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent dance," and whether a notice of licensure 180 days prior to marketing is necessary. Neither side seemed to come away with a decisive win. Sandoz began the arguments on why the additional six months would further delay biosimilars from launching, also explaining why the ...
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    US Supreme Court to Consider Biosimilar Patent Process Next Week

    The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA). The case, which will be decided by July, may set a precedent not only on whether the patent dance is neces...
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    Strategies Adopted by Innovator Companies in Response to Biosimilars Competition

    This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars. Introduction Over the last 25 years, biologic medicines have transformed how several chronic and life-threatening diseases are treated. Because of the great value of these innovative biologic medicines and the capital required to bring them to market, they are able to command high prices. For e...
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    FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity

    As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's recommendations for switching studies. Background In January, FDA released its draft guidance on biosimilar interchangeability for consultation, noting that there is "no single data package that will work for all proposed interchangeable pr...
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    Are Biosimilars 'Interchangeable' in the EU? A New Perspective

    The EU’s take on the class of medicines known as biosimilars is a slight variation of what is seen in the US, where there are two distinct types: Follow-on biologics that are biosimilar, or "expected to produce the same clinical result as the reference product," and ones that are "interchangeable," or able to be switched with their reference product. Arguments over interchangeability in the US (from whether pharmacists should be allowed to switch a biologic for its...
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    FDA Transparency: Agency’s Hands Tied by its own Regulations

    Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality. And in some areas, like with CRLs, which are letters sent by FDA when medical product applications cannot be approved, research fr...
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    EU Industry Groups Urge Caution on Biosimilar Switching

    Three EU biopharmaceutical industry groups are offering key considerations to physicians when switching from a biologic reference product to its biosimilar or from one biosimilar of a reference product to another, according to a new position paper released on Thursday. While noting a lack of regulatory requirements for individually approved biosimilars to the same reference product to be compared with each other, the trio note: “Switching between biosimilars represents ...
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    Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics

    In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted. The 49-page brief comes as the Supreme Court will hear oral arguments on 26 April over a dispute between Novartis’ ...
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    Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar

    Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents. According to the complaint , Amgen has opted into the information exchange procedures under the Biologics Price Competition and Innovatio...
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    FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix

    The US Food and Drug Administration (FDA) approved a new biologic this week, but its name did not adhere to recently finalized guidance calling for all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names. “This week’s biologic, [ Valeant Pharmaceuticals ’] Siliq (brodalumab) was licensed under section 351(a) of the Public Health Service Act , and thus is within the scope of our recently ...