GUEST COLUMNISTS

  • Biosimilar Litigation Review: Anticompetitive Conduct Cases & Post-Grant Patent Challenges

    This is the fourth article in a four-part series on 2019 legal developments related to the biosimilar sector. In this final installment, we cover 2019 biosimilar litigation related to anticompetitive conduct and post-grant patent challenges at the Patent Trial and Appeal Board (PTAB), and look ahead to what biosimilar developers can anticipate in 2020.

  • Biosimilar Litigation Review: BPCIA Federal Circuit Appeals Pending & Recently Decided

    This is the third article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding BPCIA district court litigation and reviewed ongoing BPCIA district court cases. Part 2 covered BPCIA district court cases that were settled in 2019. Here in Part 3, we review BPCIA Federal Circuit appeals that are pending and those that were recently decided.

  • An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report

    To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle. 

  • Biosimilar Litigation Review: BPCIA Cases Settled Or Dismissed In 2019

    This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding Biosimilars Price Competition and Innovation Act district court litigation and reviewed ongoing BPCIA district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.

  • Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?

    Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

  • Biosimilar Litigation Review: Ongoing BPCIA District Court Cases To Watch

    Biosimilars Price Competition and Innovation Act (BPCIA) litigants and Federal and district courts grappled with new issues in 2019. In Part 1 of this article series, we summarize BPCIA district court litigation and review ongoing court cases.

  • 6 Important Elements Of The New STRONGER Patents Act

    Over the past decade, patent reform has been an area of emphasis for Congress, with the passage of The America Invents Act of 2011 (AIA) and, more recently, the filing of a revised version of the STRONGER Patents Act in July 2019.

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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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In line with a Congressional directive, the FDA must transition products previously approved as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to biologics under the Public Health Service Act (PHS Act) by March 23, 2020. This collection of articles examines the upcoming regulatory transition in depth, sharing industry and patient perspectives on the changing regulatory requirements and market access strategies and concerns for this critical class of medicines.

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