FDA to discuss Celltrion's Remicade biosimilar

FDA's Arthritis Advisory Committee will meet Feb. 9 to discuss a BLA from Celltrion Inc. (KOSDAQ:068270) for CT-P13, a proposed biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK).

Celltrion is seeking approval of CT-P13 to treat all the indications for which Remicade is approved, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis and psoriatic arthritis. ...