Licia Maria Rodrigues

Background: Biologics improve outcomes in inflammatory bowel disease, but high costs restrict access and strain healthcare resources. Biosimilars lower costs, expand access, and support sustainable IBD care. Objective: Provide clear, evidence-based answers on biosimilar use in IBD across clinical, therapeutic, and economic domains to guide safe implementation and informed decision-making. Methods: GEDIIB conducted a PICO-structured systematic review across multiple databases and trial registries. We extracted clinically relevant outcomes and performed systematic review. We assessed risk of bias with RoB 2.0 and ROBINS-I and graded certainty using GRADE. A structured Delphi process with two voting rounds and external validation finalized recommendations, with consensus predefined at 85 percent or higher. Results: Anti-TNF biosimilars and originator biologics have similar efficacy, safety, immunogenicity, treatment persistence, and mucosal healing in biologic-naive patients and after switching, with no clinically meaningful differences in adverse events, loss of response, or discontinuation. Data on multiple switches do not indicate harm, though evidence remains limited. Pediatric studies suggest similar profiles, with lower precision. Economic evaluations show substantial cost savings and improved access, supporting the sustainability of the health system. Conclusion: Biosimilars represent a viable, safe, and cost-effective option for IBD management. We recommend structured switching strategies, clear communication with patients, and continuous clinical monitoring. Additional robust studies should strengthen evidence in specific populations and clinical scenarios.