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.