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    FDA Science Board Weighs Plan for 'Cures' Funds

    The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act . Last week, FDA released its proposal for how it would spend the funds ahead of Tuesday’s meeting, with the bulk of the funds to be devoted to sections of the law on "Advancing New Drug Therapies" and "Patient Access to Therapies and Information."...
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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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    Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars

    The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars for Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab). Amgevita is authorized for all of the same indications as Humira, while Solymbic, which won approval through a duplicate marketing authorization application (MAA), is authorized for all indications except polyarticular juvenile idiopathic arthritis. Duplicate MAAs: Public Health or Co-Mar...
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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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    EMA Recommends Two Amgen Humira Biosimilars

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended eight medicines for approval, including two Amgen biosimilars for AbbVie’s blockbuster Humira (adalimumab). Amgevita and Solymbic are the first adalimumab biosimilars recommended for approval in the EU. Humira was first authorized in the EU on 8 September 2003. The EMA recommendations were announced on the same day AbbVie announced Humira sales of $16 ...
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    EU Pharma Patent Settlements Still Limiting Entry of Generics

    Almost three-quarters of 125 patent settlements in the EU in 2015 between originator pharmaceutical and their generic competitors resulted in a lengthening of time to bring the cheaper generic version to market. But of those 74%, only 10% were settlements limiting generic market entry and including a payment or transfer of value from originator to generic company, while 64% were settlements limiting generic entry but with no value transfer. The remaining 26% of settlemen...
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    FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel

    The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be known as Erelzi (etanercept-szzs) for all indications included in the reference product’s label. Erelzi is the second biosimilar approved via the Biologics Price Competition and Innovation Act in the US from Sandoz (the first was for Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen). The approval of Erelzi follows a unani...
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    Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market?

    It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare. But what most people, particularly those outside the pharmaceutical industry, don’t realize is that what’s constraining the dissemination...
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    Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels

    Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label. The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product. However, th...
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    FDA Staff: Sandoz’s Enbrel Biosimilar is ‘Highly Similar’ to Amgen's Blockbuster

    Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.” “In considering the totality of the evidence submitted, the data submitted by the Applicant [Sandoz] show that GP2015 is highly similar to US-licensed Enbrel, notwithstanding minor differences i...
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    FDA Staff Back Biosimilar to Compete With Blockbuster Humira

    Competition for one of the world’s top-selling biologics – AbbVie’s Humira (adalimumab) – is likely to come in the near future, as staff at the US Food and Drug Administration (FDA) said Friday that Amgen’s biosimilar has “no clinically meaningful differences” with the US-licensed Humira, in terms of safety, purity and potency. Amgen’s biosimilar will go before an FDA advisory committee next Tuesday, and if it is eventually approved (FDA has a deadline of 25 September 2...