FDA Approves Fourth Biosimilar to Remicade

Amgen received FDA approval for its Remicade biosimilar, Avsola (infliximab-axxq), marking the fourth biosimilar the agency has approved for Janssen’s immunosuppressive drug.

The intravenous drug was approved for treating Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis and psoriatic arthritis. The agency is requiring a warning that directs patients to stop using the drug if they develop a serious infection.

Amgen pulled its EMA application for the biosimilar in May, citing “a change in product strategy,” but did not rule out a future submission.