SYSTEMATIC REVIEW AND BRAZILIAN EXPERT CONSENSUS ON THE USE OF BIOSIMILARS IN INFLAMMATORY BOWEL DISEASE: BRAZILIAN ORGANIZATION FOR CROHN'S AND COLITIS.

In 30 seconds

This systematic review and Brazilian expert consensus assessed biosimilar use in inflammatory bowel disease (IBD), addressing clinical, therapeutic, and economic questions. The review used a PICO framework, risk-of-bias assessment, and GRADE; recommendations were finalized through a two-round Delphi process with external validation. Anti-TNF biosimilars showed similar efficacy, safety, immunogenicity, treatment persistence, and mucosal healing to originator biologics in biologic-naive patients and after switching, without clinically meaningful differences in adverse events, loss of response, or discontinuation. Economic evaluations indicated substantial cost savings and improved access.

Key findings

• Anti-TNF biosimilars and originator biologics had similar efficacy, safety, immunogenicity, treatment persistence, and mucosal healing in biologic-naive patients and after switching.
• No clinically meaningful differences were reported in adverse events, loss of response, or treatment discontinuation.
• Available evidence on multiple switches did not indicate harm, although it remains limited; pediatric findings were similar but less precise.
• Economic evaluations found substantial cost savings and improved access.

Why it matters

Biosimilars may help address the cost and access barriers associated with biologic treatment for IBD while maintaining outcomes comparable to originator biologics in the populations and switching contexts reviewed. The consensus also highlights implementation considerations—communication, structured switching, and monitoring—that can support informed decisions and sustainable care.

What to keep in mind

Evidence on multiple switches remains limited, and pediatric studies have lower precision. The authors call for more robust studies in specific populations and clinical scenarios.