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  • Review Article
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Biosimilars in IBD: from theory to practice

Nature Reviews Gastroenterology & Hepatology volume 14, pages 22–31 (2017)Cite this article

Subjects

Key Points

  • Biosimilars are copy versions of the innovator biologic agents; they are expected to be as effective and safe as the originators for the approved therapeutic indications

  • Currently >20 biosimilars to infliximab and adalimumab are in development; the first biosimilar to infliximab, CT-P13, obtained European Medicines Agency approval in 2013 and FDA approval in 2016, and was followed by SB2 in 2016 in Europe

  • Data extrapolation across indications does not imply less reassurance of biosimilar efficacy and safety when supported by scientific justification but a process for saving time, resources and unnecessary experimental repetition; nevertheless, post-marketing studies are important

  • The first 'real-world' data in IBD are reassuring that CT-P13 is effective and well-tolerated

  • Regulatory approval does not mean that the biosimilar is interchangeable with its originator; the FDA can designate a biosimilar as interchangeable, whereas decisions rely on national competent authorities in Europe

  • In Europe, average biosimilar prices have been ∼30% lower than the reference products; biosimilars are expected to gain a portion of the market, reduce health-care expenses and improve patient access to biologic therapies

Abstract

Biologic agents have revolutionized the care management of many life-threatening and debilitating diseases. As patents for older biologic therapies have begun to expire, the market has opened to copy versions of the originators — commonly referred to as biosimilars, follow-on biologic agents or subsequent-entry biologic agents — which are expected to gain a portion of the market, reduce health-care spending and increase treatment access worldwide. Importantly for patients with IBD, CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the European Medicines Agency in September 2013 and by the FDA in April 2016. In May 2016, SB2 was the second biosimilar to infliximab receiving marketing authorization in Europe. Currently, >20 other biosimilars to infliximab and adalimumab are in the development pipeline. Their similar-but-not-identical nature, and the concept of extrapolating efficacy and safety data from one therapeutic indication to another, seem to be confusing to physicians and cause concerns about the efficacy and safety of biosimilar products. A relevant debate is still ongoing in the field of IBD. This Review discusses the scientific principles underlying the biosimilar concept established in Europe and the USA, and discusses the current state of knowledge on biosimilar use in IBD.

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Figure 1: Biosimilar development process.
Figure 2: Switching of biologic agents and biosimilars.
Figure 3: Biosimilars for adalimumab and infliximab in the pipeline.

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Acknowledgements

S.B. is supported by the Fondazione Italiana per la Ricerca Sulle Malattie Apparato Digerente.

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Authors and Affiliations

  1. Department of Biomedical Sciences, Humanitas University, Via Manzoni 113, Rozzano, 20089, Milan, Italy

    Silvio Danese

  2. Department of Gastroenterology, IBD Center, Humanitas Clinical and Research Center, Via Manzoni 56, Rozzano, 20089, Milan, Italy

    Silvio Danese & Stefanos Bonovas

  3. Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France

    Laurent Peyrin-Biroulet

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  1. Silvio Danese
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  2. Stefanos Bonovas
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  3. Laurent Peyrin-Biroulet
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All authors contributed equally to this manuscript.

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Correspondence to Silvio Danese.

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Competing interests

S.D. has served as a speaker, a consultant and an advisory board member for Abbvie, Allergan, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Hospira, Johnson & Johnson, Merck, MSD, Takeda, Mundipharma, Pfizer, Sandoz, Tigenix, UCB Pharma and Vifor. L.P.-B. has received consulting fees from Abbvie, Amgen, Biogaran, Biogen, Boerhinger-Ingelheim, Bristol–Myers Squibb, Celgene, Celltrion, Ferring, Forward Pharma, Genentech, H.A.C. Pharma, Hospira, Index Pharmaceuticals, Janssen, Lycera, Merck, Lilly, Mitsubishi, Norgine, Pfizer, Pharmacosmos, Pilège, Samsung Bioepis, Sandoz, Takeda, Therakos, Tillots, UCB Pharma and Vifor, and lecture fees from Abbvie, Ferring, H.A.C. Pharma, Janssen, Merck, Mitsubishi, Norgine, Takeda, Therakos, Tillots and Vifor. S.B. declares no competing interests.

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Danese, S., Bonovas, S. & Peyrin-Biroulet, L. Biosimilars in IBD: from theory to practice. Nat Rev Gastroenterol Hepatol 14, 22–31 (2017). https://doi.org/10.1038/nrgastro.2016.155

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