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The Biosimilar Revolution: Coming to an IBD Patient Near You?

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Inflammatory Bowel Disease

Part of the book series: Clinical Gastroenterology ((CG))

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Abstract

The emergence of biologic therapies almost 20 years ago revolutionized the treatment of inflammatory bowel diseases (IBD), and these therapies are now widely acknowledged to be the most effective agents currently available for the treatment of these conditions. As the initial biologic agents start to come off patent, biosimilar agents have emerged as alternatives to the originator drugs. Given the unique drug development and manufacturing processes involved in the creation of biologic agents, it poses distinct regulatory challenges compared to generic compounds of conventional medications. Reductions in medication costs have been touted as a major benefit of biosimilar therapies but there are concerns regarding the adequacy of existing regulatory processes and data requirements for biosimilar therapy approval, and the true “bioequivalence” of these agents. Infliximab biosimilars for the treatment of inflammatory bowel disease have been available in Europe and Asia for a few years, and are expected to become available in the USA in 2017–18. In this chapter, we will discuss how biosimilars are approved, the clinical data that have led to the approval of CT-P13 along with available postmarketing data in IBD, and the controversies and unanswered questions that remain.

Disclosures: SP has no relevant disclosures. RP is a consultant and has received financial support from Abbvie, Abbott, Amgen, Aptalis, AstraZeneca, Baxter, Biogen Idec, Eisai, Ferring, Genentech, Janssen, Merck, Shire, Elan, Glaxo-Smith Kline, Hospira, Pfizer, Bristol-Myers Squibb, Takeda, Cubist, Celgene, Salix. DTR is a consultant and has received grant support from Abbvie, Janssen, Takeda, Pfizer, Amgen, Samsung/Bioepis, and is Chair, Government and Industry Affairs Committee, Crohn’s & Colitis Foundation of America.

The chapter was sourced in part from the article “Paramsothy S, Krugliak Cleveland N, Zmeter N, Rubin DT. The role of biosimilars in inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2016;12(12):741–751.”

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Authors and Affiliations

  1. Department of Medicine, Inflammatory Bowel Disease Center, The University of Chicago Medicine, MC 4076, Room M421, 5841 S. Maryland Avenue, 60637, Chicago, IL, USA

    Sudarshan Paramsothy MD & David T. Rubin MD

  2. Inflammatory Bowel Disease Clinic, University of Calgary, 3280 Hospital Drive Rm. 6D32 TRW Building NW, Calgary, T2N 4N1, AB, Canada

    Remo Panaccione MD

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  1. Sudarshan Paramsothy MD
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Correspondence to Remo Panaccione MD .

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  1. Inflammatory Bowel Disease Center, The University of Chicago Medicine, Chicago, Illinois, USA

    Russell D. Cohen

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Paramsothy, S., Rubin, D.T., Panaccione, R. (2017). The Biosimilar Revolution: Coming to an IBD Patient Near You?. In: Cohen, R. (eds) Inflammatory Bowel Disease. Clinical Gastroenterology. Humana Press, Cham. https://doi.org/10.1007/978-3-319-53763-4_13

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