European pediatricians say caution and long-term safety and efficacy studies are needed before switching children with IBD to biosimilars.
A group of 10 pediatric specialists has published a statement calling for children with inflammatory bowel disease (IBD), who are already doing well on specific biologic medications, not to be switched to recently-approved biosimilar products.
The specialist Pediatric IBD Porto Group acknowledge that while biosimilars may reduce costs and increase access to effective biological medications, there is a need for long-term studies to confirm their safety and effectiveness, specifically in children with IBD. They also stress the importance of post-marketing monitoring programs to confirm the efficacy, safety and immunogenicity of new biosimilar products.
Based on studies for other diseases (such as rheumatoid arthritis), the European Medicines Agency has approved the use of biosimilars for the anti-TNF product infliximab for all conditions, including IBD.