Insights on the use of biosimilars in the treatment of inflammatory bowel disease

Abstract

Biologic therapy, such as those that target tumor necrosis factor (TNF) signaling, has proven to be an efficacious method of treatment for patients with inflammatory bowel disease (IBD) with regards to symptom management and mucosal healing. However, the rising prevalence of IBD worldwide and the ever-increasing burden of biologic pharmaceuticals in the health care industry is alarming for insurance companies, clinicians, and patients. The impending patent expiry and the relatively high costs of biologics, particularly anti-TNF agents, have paved the way for biosimilar development for IBD. The United States Food and Drug Administration defines a biosimilar as a biological product that is highly similar to its reference medicinal product, with no clinically meaningful differences in terms of safety, purity, and potency. The hope with biosimilars is that their entry into the market will be able to drive competition between pharmaceutical companies to reduce prices like that of the generic market, and that access to appropriate biologic treatments for IBD patients is increased in the long-term. Yet, there are challenging issues such as indication extrapolation and interchangeability that are still being debated in the field of IBD and must be addressed in future issued guidance. This review will discuss the issues and implications concerning the use of biosimilar therapy for IBD.

Keywords: Biosimilar, Biologic, Inflammatory bowel disease, Ulcerative colitis, Crohn’s disease, Indication extrapolation, Interchangeability

Core tip: The expiration of patent protection for various biologics and increasing health care expenses has paved the way for biosimilars to enter the market. The introduction of biosimilars is expected to produce cost savings in the health care industry as well as provide patients with inflammatory bowel disease with wider access to treatment.