Biosimilars in the Treatment of Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is often treated with biologic agents, such as infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-α. Biosimilars are biologic agents developed to have similar biological properties in terms of safety and efficacy as the reference or innovator biologic. The development of biosimilars requires extensive preclinical testing, but entry of biosimilars into the clinical market does not require as extensive clinical testing as for innovator biologics. Since biologics such as infliximab are clinically indicated for rheumatologic conditions as well as for IBD, and biosimilar infliximab has been shown to be efficacious in the treatment of rheumatologic and other inflammatory conditions, there are concerns regarding the appropriateness of clinical extrapolation of the indication for biosimilar infliximab to the treatment of IBD. This chapter summarizes the issues surrounding the use of biosimilars in the treatment of IBD.