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Under the Umbrella of Clinical Pharmacology: Inflammatory Bowel Disease, Infliximab and Adalimumab, and a Bridge to an Era of Biosimilars

Overview
Journal Pharmaceutics
Publisher MDPI
Date 2022 Sep 23
PMID 36145514
Authors
Affiliations
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Abstract

Monoclonal antibodies (MAbs) have revolutionized the treatment of many chronic inflammatory diseases, including inflammatory bowel disease (IBD). IBD is a term that comprises two quite similar, yet distinctive, disorders-Crohn's disease (CD) and ulcerative colitis (UC). Two blockbuster MAbs, infliximab (IFX) and adalimumab (ADL), transformed the pharmacological approach of treating CD and UC. However, due to the complex interplay of pharmacology and immunology, MAbs face challenges related to their immunogenicity, effectiveness, and safety. To ease the burden of IBD and other severe diseases, biosimilars have emerged as a cost-effective alternative to an originator product. According to the current knowledge, biosimilars of IFX and ADL in IBD patients are shown to be as safe and effective as their originators. The future of biosimilars, in general, is promising due to the potential of making the health care system more sustainable. However, their use is accompanied by misconceptions regarding their effectiveness and safety, as well as by controversy regarding their interchangeability. Hence, until a scientific consensus is achieved, scientific data on the long-term effectiveness and safety of biosimilars are needed.

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References
1.
Vena G, Cassano N . Drug focus: adalimumab in the treatment of moderate to severe psoriasis. Biologics. 2009; 1(2):93-103. PMC: 2721299. View

2.
Vulto A, Jaquez O . The process defines the product: what really matters in biosimilar design and production?. Rheumatology (Oxford). 2017; 56(suppl_4):iv14-iv29. PMC: 5850795. DOI: 10.1093/rheumatology/kex278. View

3.
Lukas M, Malickova K, Kolar M, Bortlik M, Vasatko M, Machkova N . Switching From Originator Adalimumab to the Biosimilar SB5 in Patients With Inflammatory Bowel Disease: Short-term Experience From a Single Tertiary Clinical Centre. J Crohns Colitis. 2020; 14(7):915-919. DOI: 10.1093/ecco-jcc/jjaa001. View

4.
Gamez-Belmonte R, Hernandez-Chirlaque C, Arredondo-Amador M, Aranda C, Gonzalez R, Martinez-Augustin O . Biosimilars: Concepts and controversies. Pharmacol Res. 2018; 133:251-264. DOI: 10.1016/j.phrs.2018.01.024. View

5.
Bau M, Zacharias P, Ribeiro D, Boaron L, Steckert Filho A, Kotze P . SAFETY PROFILE OF ANTI-TNF THERAPY IN CROHN'S DISEASE MANAGEMENT: A BRAZILIAN SINGLE-CENTER DIRECT RETROSPECTIVE COMPARISON BETWEEN INFLIXIMAB AND ADALIMUMAB. Arq Gastroenterol. 2017; 54(4):328-332. DOI: 10.1590/S0004-2803.201700000-43. View