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Biosimilars in the Treatment of Inflammatory Bowel Disease: Supporting Evidence in 2017

  • Inflammatory Bowel Disease (G Lichtenstein, Section Editor)
  • Published:
Current Treatment Options in Gastroenterology Aims and scope Submit manuscript

Abstract

Purpose of Review

Monoclonal antibodies targeting tumor necrosis factor-alpha, integrin molecules, and interleukin-12/23 have become backbone therapies for Crohn’s disease and ulcerative colitis. While clinically effective, these biologic therapies come with significant expense, contributing to overall healthcare spending in the USA. Biosimilars have the potential to significantly reduce expenditures secondary to the use of biologic medications such as infliximab and adalimumab, though their complicated manufacturing process results in inherent differences in structure when compared to the originator compounds. In this article, we review the available literature regarding biosimilars in IBD.

Recent Findings

Several biosimilar agents to infliximab and adalimumab are currently FDA-approved, with many more currently in development. Initial clinical trials for approval have been conducted in one of the original indications for each originator biologic. There are growing data demonstrating similar clinical efficacy, immunogenicity, and safety of each of the approved infliximab and adalimumab biosimilars, both through indication extrapolation from other diseases such as rheumatoid arthritis and ankylosing spondylitis, as well observational data in patients with inflammatory bowel disease. Further research is ongoing regarding the efficacy and safety of substitution and interchangeability of biosimilars, as well as therapeutic drug monitoring for biosimilar agents.

Summary

Research to date supports the utilization of reference biologics and biosimilars for new initiators, while additional data are being accrued regarding the interchangeability between these agents.

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Authors and Affiliations

  1. Crohn’s and Colitis Center, Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, 1635 Aurora Court, Room 2.031, Mail Stop F735, Aurora, CO, 80045, USA

    Frank I. Scott MD MSCE

  2. Gastroenterology Division, Perelman School of Medicine, University of Pennsylvania, 7th Floor South Perelman Building, Room 753, 3400 Civic Center Boulevard, Philadelphia, PA, 19104-4283, USA

    Gary R. Lichtenstein MD

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Correspondence to Frank I. Scott MD MSCE.

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Conflict of Interest

Frank I. Scott has received a grant from Takeda Pharmaceuticals and has received personal fees from Janssen Pharmaceuticals and Merck Pharmaceuticals.

Gary R. Lichtenstein has received personal fees from Abbvie, Actavis, Alaven, Ironwood, Gilead, Hospira, Luitpold/American Regent, Merck, McMahon Publishing, Prometheus Laboratories, Romark, Salix Pharmaceuticals/Valent, Shire Pharmaceuticals, SLACK, Inc., Springer Science and Business Media, UCB, and Up-To-Date. Dr. Lichtenstein has also received grants and personal fees from Celgene, Janssen Ortho Biotech, Pfizer Pharmaceuticals, and Takeda, and honorarium payments from Clinical Advances in Gastroenterology and Gastroenterology and Hepatology (Gastro-Hep Communications).

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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This article is part of the Topical Collection on Inflammatory Bowel Disease

The editors would like to thank Dr. Gary Falk for taking the time to review this manuscript.

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Scott, F.I., Lichtenstein, G.R. Biosimilars in the Treatment of Inflammatory Bowel Disease: Supporting Evidence in 2017. Curr Treat Options Gastro 16, 147–164 (2018). https://doi.org/10.1007/s11938-018-0177-z

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