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Current Treatment Options in Gastroenterology

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01-03-2018 | Inflammatory Bowel Disease (G Lichtenstein, Section Editor)

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

Authors: Frank I. Scott, MD MSCE, Gary R. Lichtenstein, MD

Published in: Current Treatment Options in Gastroenterology | Issue 1/2018

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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Title: Biosimilars in the Treatment of Inflammatory Bowel Disease: Supporting Evidence in 2017
Authors: Frank I. Scott, MD MSCE
Gary R. Lichtenstein, MD
Publication date: 01-03-2018
Publisher: Springer US
Published in: Current Treatment Options in Gastroenterology / Issue 1/2018
Print ISSN: 1092-8472
Electronic ISSN: 1534-309X
DOI: https://doi.org/10.1007/s11938-018-0177-z

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