The Arthritis Advisory Committee's discussion of interchangeability during its review of Celltrion Inc.'s Inflectra (CT-P13) highlights the information gap that FDA will have to bridge with clinicians, patients and others both before and after a biosimilar is deemed to be interchangeable with its reference product.
Celltrion is not seeking interchangeable status for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s Remicade (infliximab). Nevertheless, the Feb. 9 advisory committee meeting featured a host of questions...