“Use of Biosimilars in Paediatric Inflammatory Bowel Disease” Position Statement. JPGN 2015; 61: 503-08. Conclusions:
- “IBD Porto group advocates giving high priority to performing paediatric trials with long-term followup to support” the use of biosimilars (97% agreement)
- “Treatment of a child with sustained remission on a specific medication should not be switched to a biosimilar until clinical trials in IBD are available to support the safety and efficacy of such a change” (94% agreement)
- “Postmarketing surveillance…in children with IBD should be a mandatory requirement.” (100% agreement)
My take: Keep this reference handy. The lower expected costs (>30% reduction) could create pressure to change treatment before the safety/efficacy is proven.