Biosimilars -Position Statement

Briefly noted:

“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.

Atlanta Botanical Gardens

Atlanta Botanical Gardens

2 thoughts on “Biosimilars -Position Statement

  1. Pingback: European Experience with Biosimilars | gutsandgrowth

  2. Pingback: Role of Biosimilars in Inflammatory Bowel Disease | gutsandgrowth

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