Development, safety, and efficacy of biosimilar adalimumab: the data so far

Abstract

Biologics are defined as active substances derived from living cells or organisms with the aid of biotechnology methods. A similar biological medicinal product, commonly referred to as a biosimilar, is a copy version of an approved original biological medicine whose data protection has expired. The main advantage of biosimilars is to lower prices and create financial savings for health care systems. Adalimumab (Humira) is a human recombinant monoclonal antibody against tumor necrosis factor-α, licensed for the treatment of several rheumatologic diseases and inflammatory bowel diseases. The original biologic agent has worldwide sales of approximately 12.5 billion US dollars, but the patent will expire in 2016 for the US and in 2018 for Europe. Adalimumab biosimilar is already currently marketed and used in a clinical setting in India, but many other companies are testing adalimumab biosimilars in order to request authorization from the European Medicines Agency and the US Food and Drug Administration at the time of patent expiry. In this gold rush, the long-term safety and immunogenicity of these drugs are an issue, but the striking rise of pharmaceutical expenses makes these drugs highly attractive for health care systems and pharmaceutical companies.