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  • Regulatory NewsRegulatory News

    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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    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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    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...
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    Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory

    The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review. The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that th...
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    TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators

    The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients. The group is working to leverage the data and best practices of its members, such as Pfizer, Amgen, AstraZeneca, Merck and Roche, across a wide swath of trial-relate...
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    Sandoz Petitions Supreme Court to Rule on Biosimilars

    Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...
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    European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. NICE Takes Sides in Fight for PCSK9 Market, Recommending Amgen While Rejecting Sanofi The National Institute of Health and Care Excellence (NICE) has recommended using Amgen’s PCSK9 inhibitor Repatha in certain indications, while rejecting the use of Sanofi and Regeneron’s rival drug Praluent. While both manufacturers offered discounts of undisclosed magnitudes, only A...
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    European Commission Clears First Enbrel Biosimilar Ahead of US

    The European Commission over the weekend signed off on the first biosimilar for Amgen’s blockbuster rheumatoid arthritis treatment Enbrel, a version of which is also making its way through a separate review by the US Food and Drug Administration (FDA). With almost $5 billion in annual sales last year (and almost $9 billion in 2014 sales), the biosimilar version of the treatment from Samsung Bioepis, known commercially as Benepali (etanercept), could help to drive down pr...