Additional Research is Needed to Confirm Safety, Efficacy of Biosimilar Meds for Children

A consensus statement issued by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) cautions against switching pediatric patients with inflammatory bowel disease (IBD) to recently approved “biosimilar” medications, if they are responding well to their current biological agents. The statement acknowledges the cost advantages of biosimilars, but urges further long-term study to confirm their efficacy, safety, and immunogenicity, or propensity to develop antibodies that would interfere with continued use of the medications. The statement is published in the Journal of Pediatric Gastroenterology and Nutrition.

Biological agents that are directed against tumor necrosis factor (TNF) have become increasingly important in the treatment of pediatric IBD. They are complex, protein-based drugs, and as their patents expire, new versions that are similar, but not identical, are coming to market. Although this trend has the beneficial effect of decreasing cost and promoting wider access, the group statement cautions that even minor variations between the biosimilars and their originals may affect their suitability in children with IBD. The group advocates giving priority to pediatric trials with long-term follow up and to making postapproval effectiveness and safety monitoring a “mandatory requirement” for the marketing of biologics and biosimilars with respective indications.

Read about proteins and Crohn’s disease.

Read more about the panel recommendations, with link to the full article, here.


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