Celltrion submits first biosimilar mAb application to FDA

Celltrion Inc. (KOSDAQ:068270) submitted an application to FDA for Remsima infliximab, a biosimilar of Remicade from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). The application is the first biosimilar mAb application to be submitted in the U.S., according to Celltrion. The antibodies inhibit tumor necrosis factor (TNF) alpha.

Hospira Inc. (NYSE:HSP) deferred to Celltrion for details on whether the partners are seeking interchangeability designation with Remicade or the specific indications for which they are seeking approval. FDA has told BioCentury that interchangeability is an additional standard to meet beyond biosimilarity, and manufacturers must show that the proposed "interchangeable product is expected to produce the same clinical result as the reference product in any given patient" (see BioCentury, July 28). ...