Meeting Report: AGA Biosimilars Roundtable

  • Colin W. Howden
    University of Tennessee Health Science Center, Memphis, Tennessee

    AGA Center for Diagnostics and Therapeutics, Bethesda, Maryland
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  • Gary R. Lichtenstein
    Reprint requests Address requests for reprints to: Gary R. Lichtenstein, MD, 7th Floor Perelman Center for Advanced Medicine, Room 753, Hospital of the University of Pennsylvania 3400 Civic Center Boulevard, Philadelphia, PA 19104-4283. Telephone: (215)349-8222.
    University of Pennsylvania, Philadelphia, Pennsylvania

    AGA Center for Diagnostics and Therapeutics, Bethesda, Maryland
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      In December 2017, the American Gastroenterological Association (AGA) Center for Diagnostics and Therapeutics (CDT) and the AGA Biosimilars Advisory Panel held a roundtable meeting in Washington, DC, to review the current and potential use of biosimilars in inflammatory bowel disease (IBD). This was a closed meeting with representation from clinical gastroenterology (adult and pediatric), the US Food and Drug Administration (FDA), the Crohn’s and Colitis Foundation, a legal firm active in patent litigation in this area (Goodwin Procter), and 4 pharmaceutical companies with interest in the field (namely, AbbVie, Amgen, Boehringer Ingelheim, and Pfizer). Additional pharmaceutical companies were invited to participate but did not attend. This was a 1-day meeting with a brief introductory session on the preceding evening.

      Abbreviations used in this paper:

      aBLA (abbreviated Biologics License Application), AGA (American Gastroenterological Association), APPs (advanced practice providers), BPCIA (Biologic Price Competition and Innovation Act), CDT (Center for Diagnostics and Therapeutics), FDA (US Food and Drug Administration), IBD (inflammatory bowel disease), RPS (reference product sponsors)
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