Adalimumab: a review of the reference product and biosimilars

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

Acknowledgments

The authors thank the support of Edumed Biotech staff for helping to review this article. This work was not produced with any financial support.

Disclosure

Valderílio Feijó Azevedo is a speaker for Pfizer, Inc., AbbVie Inc., Hoffman-La Roche Ltd., BMS, Celltrion, Janssen Pharmaceutica, Sanofi, Novartis International AG, AstraZeneca plc, and Union Chimique Belge. Doctor Valderílio Feijó Azevedo has produced graphic materials to AbbVie Inc., Janssen Pharmaceutica, BMS, Pfizer, Inc., and Novartis International AG. He also is part of the advisory board of AbbVie Inc., Janssen Pharmaceutica, BMS, Pfizer, Inc., Merck Serono, and AstraZeneca plc. Ludmila Della Coletta Troiano, Natalia Bassalobre Galli, Alais Kleinfelder, Nathan M Catolino, and Paulo Cesar Urbano Martins report no conflicts of interest in this work.