The Role of Biosimilars in Inflammatory Bowel Disease.

Monoclonal antibody biologic therapies, introduced nearly 20 years ago, revolutionized the treatment of inflammatory bowel disease (IBD) and are now well established as the most effective agents available. As the first of these biologic agents starts to come off patent, biosimilar agents have emerged as alternatives to originator drugs. The unique drug development and manufacturing processes involved in the creation of biologic agents pose distinct regulatory challenges compared to generic formulations of conventional medications. Reductions in medication costs have been proposed to be a major benefit of biosimilar therapies; however, there are concerns regarding the adequacy of the existing regulatory process and data requirements for biosimilar therapy approval, as well as the true bioequivalence of these agents. Infliximab biosimilars for the treatment of IBD have been available in Europe and Asia for a few years and are expected to become available in the United States within the next 1 to 2 years. This article reviews biosimilar therapies and the current data with respect to IBD.