Clinical Guide to Navigating the Landscape of Biosimilars for Inflammatory Bowel Disease.

Annual out-of-pocket expenditures for patients with inflammatory bowel disease (IBD) are estimated to be as high as $41,000, with medications, such as biologics, being one of the main cost contributors. Although biologics have revolutionized IBD management, these medications are costly owing to their molecular makeup and manufacturing processes. Biosimilars, which are biologic medications that are highly similar to the US Food and Drug Administration (FDA)-approved reference product with no clinically meaningful differences in safety, purity, or potency, offer the same therapeutic benefits at a reduced cost. Other additional benefits offered with biosimilars include increased treatment access and fostered development of new therapeutic options. Despite the expansion of biosimilars in IBD, their adoption and utilization have been suboptimal in the United States. This article provides an overview of the biosimilar landscape in IBD, including FDA-approved biosimilars available, and a clinical guide to navigate switching to biosimilars in various clinical scenarios based on current evidence.