Advertisement

Meeting Report: AGA Biosimilars Roundtable

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

    AGA Center for Diagnostics and Therapeutics, Bethesda, Maryland
    Search for articles by this author
  • Gary R. Lichtenstein
    Correspondence
    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.
    Affiliations
    University of Pennsylvania, Philadelphia, Pennsylvania

    AGA Center for Diagnostics and Therapeutics, Bethesda, Maryland
    Search for articles by this author
      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)
      To read this article in full you will need to make a payment
      AGA Member Login
      Login with your AGA username and password.
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. QuintilesIMS. The impact of biosimilar competition in Europe. Available: https://ec.europa.eu/docsroom/documents/23102/attachments/1/translations/en/renditions/native. Accessed December 29, 2017.

        • Walsh G.
        • Jefferis R.
        Post-translational modifications in the context of therapeutic proteins.
        Nature Biotech. 2006; 24: 1241-1252
        • Büttel I.C.
        • Chamberlain P.
        • Chowers Y.
        • et al.
        Taking immunogenicity assessment of therapeutic proteins to the next level.
        Biologicals. 2011; 39: 100-109
        • Baker M.P.
        • Reynolds H.M.
        • Lumicisi B.
        • et al.
        Immunogenicity of protein therapeutics: the key causes, consequences and challenges.
        Self Nonself. 2010; 1: 314-322
        • Jørgensen K.
        • Berset K.
        • Ingrid P.
        • et al.
        Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial.
        Lancet. 2017; 389: 2304-2316
        • Danese S.
        • Fiorino G.
        • Raine T.
        • et al.
        ECCO position statement on the use of biosimilars for inflammatory bowel disease—an update.
        J Crohns Colitis. 2017; 11: 26-34
        • Komaki Y.
        • Yamada A.
        • Komaki F.
        • et al.
        Systematic review with meta-analysis: The efficacy and safety of CT-P13, a biosimilar of anti-tumour necrosis factor-α agent (infliximab), in inflammatory bowel diseases.
        Aliment Pharmacol Ther. 2017; 45: 1043-1057
        • Fiorino G.
        • Manetti N.
        • Armuzzi A.
        • et al.
        The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar.
        Inflamm Bowel Dis. 2017; 23: 233-243
      2. US Food and Drug Administration (FDA). From our perspective: interchangeable biological products. Available: www.fda.gov/Drugs/NewsEvents/ucm536528.htm. Accessed December 29, 2017.

        • de Ridder L.
        • Waterman M.
        • Turner D.
        • et al.
        Use of biosimilars in paediatric inflammatory bowel disease: a position statement of the ESPGHAN Paediatric IBD Porto Group.
        J Pediatr Gastroenterol Nutr. 2015; 61: 503-508