Biosimilar infliximab regulatory update

FDA’s Arthritis Advisory Committee will meet on Feb. 9 to discuss a BLA from Celltrion for CT-P13, a biosimilar of autoimmune drug Remicade infliximab. Celltrion is seeking approval of CT-P13 to treat all of the indications for which Remicade is approved, including Crohn’s disease (CD), ulcerative colitis (UC), rheumatoid arthritis, ankylosing spondylitis (AS), psoriasis and psoriatic arthritis.

The European Commission approved CT-P13 in 2013. Celltrion and Pfizer, its co-exclusive partner, market CT-P13 independently as Remsima and Inflectra. ...