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

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; ho...

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Autores principales: Milassin, Ágnes, Fábián, Anna, Molnár, Tamás
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469269/
https://www.ncbi.nlm.nih.gov/pubmed/31019554
http://dx.doi.org/10.1177/1756284819842748
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author Milassin, Ágnes
Fábián, Anna
Molnár, Tamás
author_facet Milassin, Ágnes
Fábián, Anna
Molnár, Tamás
author_sort Milassin, Ágnes
collection PubMed
description 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.
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spelling pubmed-64692692019-04-24 Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective Milassin, Ágnes Fábián, Anna Molnár, Tamás Therap Adv Gastroenterol Review 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. SAGE Publications 2019-04-15 /pmc/articles/PMC6469269/ /pubmed/31019554 http://dx.doi.org/10.1177/1756284819842748 Text en © The Author(s), 2019 http://www.creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Review
Milassin, Ágnes
Fábián, Anna
Molnár, Tamás
Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective
title Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective
title_full Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective
title_fullStr Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective
title_full_unstemmed Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective
title_short Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective
title_sort switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469269/
https://www.ncbi.nlm.nih.gov/pubmed/31019554
http://dx.doi.org/10.1177/1756284819842748
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