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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’ ...
  • Leahy Looks to Amend ‘Cures’ Bill as Senate Prepares for Passage

    Sen. Patrick Leahy (D-VT) on Tuesday proposed an amendment to the 21st Century Cures bill that would make it more difficult for brand name drugmakers to halt or delay generic or biosimilar competition. The amendment, supported by the Generic Pharmaceutical Association on Tuesday, would promote competition by further encouraging manufacturers to share product samples with generic and biosimilar companies so that more of these lower-cost treatments can be approved by th...
  • Regulatory NewsRegulatory News

    Biosimilar Interchangeability: ‘Careful What You Wish For’

    As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts are saying the designation might not actually be that important for the biosimilar market as a whole. Ronny Gal, senior analyst in specialty pharmaceuticals equity research at Sanford Bernstein, told attendees at GPhA’s first biosimilars conference on Thursday that although...
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    Woodcock on Biosimilars: Earning the Trust of Prescribers and Patients is Key

    Similar to earning the public’s trust and confidence on generic drugs more than 20 years ago, the biosimilar industry needs to work to establish the same pattern of trust and confidence now, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, told attendees at the Generic Pharmaceutical Association’s (GPhA) biosimilar conference in Bethesda, MD, on Wednesday. Bluntly put, Woodcock said biosimilar and other indu...
  • Regulatory NewsRegulatory News

    Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA

    Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the  Biologics Price Competition and Innovation Act  (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period. The provision in the BPCIA in question states that: "An approved application for a ...
  • Regulatory NewsRegulatory News

    GDUFA Reauthorization: GPhA and Catalent Make Specific Requests

    As the US Food and Drug Administration (FDA), industry and other stakeholders continue to meet and discuss what provisions the next iteration of the Generic Drug User Fee Act (GDUFA) should contain in 2017, both the Generic Pharmaceutical Association (GPhA) and contract manufacturer Catalent, among others, have outlined particular requests. Since 2012, when the first $1.5 billion GDUFA program was created to provide FDA with industry funds to ensure a more consiste...
  • Regulatory NewsRegulatory News

    GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5

    The Generic Pharmaceutical Association’s Biosimilars Council is taking issue with a recent court decision that could effectively delay the launch of biosimilars in the US by an additional six months, according to an amicus brief. Background Under the Biologics Price Competition and Innovation Act (BPCIA) -- authorized as part of Obamacare -- biosimilars can be approved via an expedited pathway and then marketed after their reference biologics are exclusively marketed fo...
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    Industry Calls for Clarity, Phased Approach for Quality Metrics

    Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) plan to request quality metrics from drugmakers, but they also call on the agency to clarify what it wants and implement a phased-in approach. Background In July, FDA released its long-awaited draft guidance , Request for Quality Metrics , which outlined the agency's plans to collect quality metrics to "further develop FDA's risk-based inspection scheduling." While the draft g...
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    HHS Pharmaceutical Pricing Forum: Lots of Questions, Few Definitive Answers

    The Department of Health and Human Services’ (HHS) invite-only Pharmaceutical Forum on Friday turned out to be more of a listening session for a range of stakeholders to explain concerns and discuss a number of potential ways to lower drug prices, some of which involve US Food and Drug Administration (FDA) reforms. HHS Secretary Sylvia Burwell kicked off the event by noting the steep cost increases for medicines, particularly for specialty drugs, which made up about $87 ...
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    FDA Finalizes Guidance on Formal Meetings with Biosimilar Sponsors

    The US Food and Drug Administration (FDA) on Wednesday plans to release finalized guidance on formal meetings between FDA and biosimilar sponsors. The agency said that as a result of the public comments on the draft guidance from April 2013, information has been added “to provide clarity on the process for requesting meetings, including identifying the appropriate meeting type and the data expectations to support the appropriate meeting type.” The Generic Pharmaceut...
  • Regulatory NewsRegulatory News

    GPhA: Congress Needs to Work With FDA to Increase Generic Competition

    The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday. ANDA Backlog First, like Hillary Clinton and many others in the past, GPhA is calling on Congress to take action to reduce the backlog of abbreviated new drug applications (ANDAs) awaiting FDA approval. The association says Congress should...
  • Regulatory NewsRegulatory News

    GPhA Questions Legality of FDA Guidance on Physical Attributes of Generic Drugs

    The Generic Pharmaceutical Association (GPhA) is raising a number of concerns, among them the legality, of the US Food and Drug Administration's (FDA) recently issued final guidance on the size, shape and other physical attributes of generic drugs. Background Since at least 2013, FDA has called on generic drug companies via draft guidance to gauge the physical differences -- including size, shape, smell, weight and surface area – and try to make generics as physically...