Efficacy and safety of biosimilars in gastroenterology: a focus on inflammatory bowel disease management.

Introduction: The introduction of biosimilars changed the management of biologicals in inflammatory bowel disease (IBD) since the approval of CT-P13, the first biosimilar to infliximab, by the European Medicines Agency (EMA) in September 2013 and by the U.S. Food and Drug Administration (FDA) in April 2016. Accumulating evidence in IBD suggests that biosimilar products have equivalent efficacy and safety to reference products and their use was associated with improved access and decrease in medication costs.

Areas covered: This review discusses the current evidence on approved biosimilars of infliximab, adalimumab and ustekinumab in IBD. Authors review data on drug sustainability, efficacy, safety, immunogenicity, non-medical switch data and interchangeability of biosimilar agents.

Expert opinion: The biosimilar concept seems to be successful and has led to increased use of biological/biosimilar agents in the treatment of IBD. Clinical trials with biosimilars in IBD and evidence from real world studies on infliximab and adalimumab biosimilars confirm that safety, efficacy and immunogenicity is comparable to the originator, and that switching from the originator or among biosimilars is safe. While payers are supporting mandatory biosimilar use, on the long run the price race can lead to obstacles and unaffordability of the development of new originator biological agents.