Current and future biosimilars: potential practical applications in rheumatology

Ghaith Noaiseh, Larry Moreland

Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA

Abstract: The use of biologics in the field of rheumatology has dramatically changed the way we treat rheumatic diseases. As the patent-expiration dates for many tumor necrosis-factor inhibitors and other biological agents are approaching, many large pharmaceutical companies are developing and testing their own versions of these agents; this is due to the biologics' huge revenue potential. The potential cost saving is a major incentive for their development. Producing a biosimilar is not an easy task, as minor changes in the production process can have profound immunological and clinical consequences. The European Medicines Agency (EMA) has led the efforts in issuing guidelines to streamline the approval process for applicants interested in developing biosimilars. The US Food and Drug Administration (FDA) has followed the EMA track and has guidelines in place, but the process varies in different countries. The approval process is far more complex than the one used for the approval of small-molecule generic products. Biosimilars should be developed according to the strict rules set forth by the EMA and FDA; other intended copies are available for clinical use in different parts of the world, but should not be considered biosimilars, as they do not fulfill the stringent definition criteria. Biosimilars will soon be in the market, and their use in rheumatic diseases will likely change our treatment approach. Rheumatologists and other health-care professionals will soon be faced with many questions and will have to be familiarized with the concept and the points of debate.

Keywords: biosimilar, rheumatology, biologic, generic, TNF inhibitor, rituximab