FDA approves Remicade biosimilar

FDA approved Inflectra infliximab-dyyb (CT- P13) from Celltrion Inc. (KOSDAQ:068270), a biosimilar of Remicade infliximab from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). The agency approved Inflectra to treat Crohn's disease in adults and in children aged six and older, ulcerative colitis (UC) or plaque psoriasis in adults, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.

Inflectra is the second biosimilar FDA has approved, and the first biosimilar mAb. The tumor necrosis factor (TNF) alpha inhibitor received approval in all of Remicade's indications except pediatric UC, for which Remicade has Orphan Drug status. Celltrion did not seek approval for pediatric UC. ...