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Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective.

ABSTRACT: Background:Biological therapy has revolutionized the treatment of inflammatory bowel disease (IBD). After the expiration of patents for biological innovator products, development of biosimilars increased. CT-P13 was the first biosimilar approved for the same indications as the reference product; however, the approval was based on extrapolated data from rheumatoid arthritis and ankylosing spondylitis. Our aim was to review clinical studies about switching from originator infliximab (IFX-O) to biosimilar infliximab (IXF-B) in IBD, focusing on recently published data and the future of biosimilars. Methods:The PubMed database was searched for original articles published up to 1 December 2018 reporting data on IFX-B in IBD. Results:A total of 29 studies assessing switching from IFX-O to IFX-B, 14 assessing induction therapy with IFX-B were found. Efficacy, safety and immunogenicity were discussed. Studies confirm that CT-P13 is safe and equally efficient as the reference product for both induction and maintenance therapy; and that switching from the reference product to biosimilar is non-inferior to continuous biosimilar use. However, efficacy and safety data on Flixabi (SB2) in IBD patients is lacking. Conclusion:Switching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars in IBD patients.

SUBMITTER: Milassin A 

PROVIDER: S-EPMC6469269 | BioStudies | 2019-01-01

REPOSITORIES: biostudies

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