FDA panel backs first biosimilar mAb

FDA's Arthritis Advisory Committee voted 21-3 to support approval of CT-P13 from Celltrion Inc. (KOSDAQ:068270), a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ), to treat seven of the eight indications for which Remicade is approved. No biosimilar mAb has received FDA approval.

Remicade is approved for rheumatoid arthritis, ankylosing spondylitis, adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis (UC), psoriatic arthritis and plaque psoriasis. Celltrion is seeking extrapolation of CT-P13 across all except pediatric UC, for which Remicade has Orphan Drug designation. ...