FDA delays meeting to discuss Remicade biosimilar

FDA's Arthritis Advisory Committee postponed a meeting that had been scheduled for March 17 to discuss a BLA from Celltrion Inc. (KOSDAQ:068270) for CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). FDA said the postponement was "due to information requests pending" with Celltrion. The agency did not announce a new date.

Celltrion said its application for CT-P13 is the first for a biosimilar mAb in the U.S. FDA will ask the committee to discuss use of the humanized mAb against tumor necrosis factor (TNF) alpha to treat rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis (see BioCentury Extra, Feb. 9). ...