Multiple switches between infliximab originator and biosimilars in pediatric inflammatory bowel disease

OBJECTIVES: Infliximab (IFX) is highly effective but costly, driving the adoption of biosimilars. Data on switching from originator IFX to biosimilars in pediatric inflammatory bowel disease (IBD) patients remain limited. This study evaluated the safety and efficacy of switching from originator IFX to IFX biosimilar CT-P13 in IBD. METHODS: In this single-center observational study, we investigated all pediatric patients with IBD on maintenance IFX therapy who were switched from originator (Remicade®) to CT-P13 (Inflectra®, switch A in cohort A) in 2018 and to CT-P13 (Remsima®, switch B in cohort B) in 2022. Cohort C includes patients who underwent both switches. Demographics, disease activity, remission rates and IFX trough levels were collected from 6 months before to 6 months after each switch. RESULTS: A total of 42 children (cohort A) and 44 children (cohort B) had a single switch to CT-P13; 14 (cohort C) had multiple switches. Median IFX trough concentration was 5.7 ([3.8-9.3) and 9.0 (6.2-11.7) µg/mL versus 6.5 (3.9-8.6) and 9.22 (7.9-10.5) µg/mL 6 months after switch in cohort A and B and 4.3 (3.4-10.9) versus 7.9 (6.9-9.7) and 9.3 (8.3-10.3) versus 9.4 (7.9-10.6) for respectively both switches in cohort C (all p > 0.05). Antibodies to IFX developed in one patient post-switch. Clinical/biological remission rates remained stable. No clinically significant changes in inflammatory biomarkers and safety profile were noted before and after switch. CONCLUSIONS: Switching to CT-P13 biosimilars appears to maintain remission without relevant changes in pharmacokinetics, disease activity, or adverse events in pediatric patients with IBD. Further studies are required.