Switching From Originator to Biosimilar Infliximab in Pediatric Inflammatory Bowel Disease: A Systematic Review and Meta‐Analysis

Abstract

ABSTRACT Background and Aims Switching from originator infliximab to a biosimilar has become routine in adults with inflammatory bowel disease, but pediatric‐specific evidence remains limited. We aimed to evaluate the efficacy and safety of this switch in patients younger than 22 years. Methods We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials through May 2026 for studies investigating the switch from originator infliximab to any approved biosimilar in pediatric patients. Risk ratios with 95% confidence intervals were pooled using random‐effects models in R. Logit‐transformed proportions were used for single‐arm outcomes. Heterogeneity was measured using the I 2 statistic. Results Eight studies including 508 patients met eligibility. Clinical remission was similar between switch and non‐switch groups both at long‐term (risk ratio 1.06, 95% confidence interval 0.95–1.19; p = 0.29; I 2 = 59%) and short‐term (risk ratio 1.08, 95% confidence interval 0.97–1.19; p = 0.16; I 2 = 0%) follow‐up. Treatment persistence was 85% (95% confidence interval 73%–92%; I 2 = 76%) in the switch group, whereas newly detectable antidrug antibodies occurred in 2.2% (95% confidence interval 0.6%–7.2%; I 2 = 0%). The mean infliximab trough difference was 0.56 μg/mL (95% confidence interval −0.50 to 1.62; p = 0.30; I 2 = 2%). Serious adverse events, infusion reactions, and dose intensification did not differ between groups. Conclusions In pediatric inflammatory bowel disease, switching to biosimilar infliximab does not appear to affect clinical remission, drug exposure, immunogenicity, or short‐term safety, supporting current non‐medical switching practice. Trial Registration PROSPERO CRD420261392963