Celltrion Inc.'s proposed biosimilar Inflectra may not be exactly the same as its reference product Remicade, and some FDA advisors struggled with how to determine whether those differences are clinically relevant.
A number of Arthritis Advisory Committee members pointed to quality attributes for Inflectra (CT-P13) – a proposed biosimilar of Janssen Biotech Inc.'s TNF inhibitor infliximab – that were not...