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Adalimumab: a review of the reference product and biosimilars

Authors Azevedo V, Dela Coletta Troiano Araujo L, Bassalobre Galli N, kleinfelder A, marostica Catolino N, martins Urbano PC

Received 13 October 2015

Accepted for publication 9 January 2016

Published 26 July 2016 Volume 2016:6 Pages 29—44


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Professor Shein-Chung Chow

Valderílio Feijó Azevedo,1,2 Ludmila Della Coletta Troiano,2 Natalia Bassalobre Galli,1 Alais Kleinfelder,1 Nathan M Catolino,1 Paulo Cesar Urbano Martins2

1Rheumatology Unit, Federal University of Paraná, 2Edumed Health Research and Biotech, Curitiba, Brazil

Abstract: Adalimumab was the first fully humanized monoclonal antibody approved by the US Food and Drug Administration (FDA). Launched in 2003, the clinical efficacy and safety of adalimumab were assessed in various trials in rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn’s Disease, and ulcerative colitis, among others. At the global level, adalimumab is a major sales success among biologicals. It is still the greatest blockbuster among monoclonal antibodies. The date of its patent expiration paves the road for several potential biosimilars in various markets worldwide. This article discusses the current situation of molecules that are the main candidates to become adalimumab biosimilars. In addition, it also addresses the production processes, clinical studies, and relevant regulatory issues relative to the approval of those molecules, which must meet the challenge of demonstrating similar efficacy and safety to Humira®, but at a lower cost.

Keywords: biosimilars, adalimumab, anti-TNF, biosimilarity

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