Emerging role of biosimilars in the clinical care of inflammatory bowel disease patients

Abstract

The increasing incidence of inflammatory bowel disease (IBD) globally has redirected the healthcare system's focus towards safe and affordable pharmacological interventions. The inception of anti-tumor necrosis factor-α (TNF-α) had resulted in a trend shift from surgical interventions. However, as the patents of approved anti-TNF-α drugs expire, biological copies of the many approved products are in the pipeline. The most commonly used biosimilar for IBD has been infliximab, followed by Adalimumab biosimilars which have been approved in major countries across the world. Although biosimilars are approved on the basis of similarity of their reference product, the lack of real-world evidence of its safety in ulcerative colitis and Crohn’s disease patients has contributed to physicians’ hesitancy. However, biosimilars are expected to reduce treatment costs and provide economic benefits.

Keywords: Inflammatory bowel disease; Biosimilars; Anti-tumor necrosis factor; Infliximab; Adalimumab; Ulcerative colitis; Chrons disease

Core Tip: There is limited evidence on the safety and use of biosimilars other than Infliximab. This review explores the role of biosimilars in an era of anti-tumor necrosis factor-α drug as a treatment option for inflammatory bowel disease. The approval of biosimilars by the Food and Drug Administration or European Medicines Agency based on their similarity and functionality to the reference product has raised concerns regarding its efficacy. Many remain hesitant in recommending biosimilars as a viable treatment option, despite its promise of reducing long-term costs. This originates from the lack of clinical trials of biosimilars. Although no serious adverse events have been reported with biosimilars, conclusions cannot be drawn without sufficient empirical evidence.