Remicade Biosimilar Review: Where 351(k) Pathway Bumps Into Orphan Drug Rules
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Arthritis Advisory Committee convenes March 17 to consider Celltrion’s biosimilar application for all nine claims on the label of J&J’s TNF inhibitor, including a pediatric claim protected by orphan drug exclusivity until 2018.