Biosimilar Inflectra Snags FDA Approval

The FDA has approved Celltrion’s Inflectra, making it the second biosimilar in the U.S.

A biosimilar of Janssen Biotech’s Remicade, Inflectra is approved for several indications: adult and pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, active psoriatic arthritis and chronic severe plaque psoriasis.

Inflectra — which will be marketed in the U.S. by Pfizer — contains a boxed warning about a risk of serious infections, including tuberculosis, bacterial sepsis and invasive fungal infections that could lead to hospitalization or death. It is not approved as an interchangeable product.