Path of Interchangeability of Biosimilars in Pediatric Inflammatory Bowel Disease: Quality Before Cost Savings.

Abstract

The advent of biosimilars in inflammatory bowel disease (IBD) represents an opportunity for cost-savings and increased patient access to effective disease-modifying therapies. While preliminary data in adult IBD and rheumatology patients suggest comparable effectiveness and pharmacokinetics between original biologics and biosimilars, long-term immunogenicity data are unknown. Without this data, conclusions about interchangeability should not be made for pediatric patients with IBD. Children affected by IBD, in particular, are a vulnerable group if automatic substitution and non-medical switching are allowed based on limited data in adult patients. Robust, long term immunogenicity data of biosimilars are needed in pediatric cohorts before policies allow interchangeability in children.