FDA approves Renflexis biosimilar to Remicade

The US Food and Drug Administration on Friday approved Renflexis (infliximab-abda) for multiple indications. Renflexis is administered by intravenous infusion.

This is the second FDA-approved biosimilar to US-licensed Remicade (infliximab).

Renflexis was developed by South Korea’s Samsung Bioepis, which is a joint venture of Samsun and US biotech firm Biogen (Nasdaq: BIIB). Its US partner, Merck & Co (NYSE: MRK), will market Renflexis in the USA, while in Europe, where it was approved last year, it will be marked by Biogen under the name Flixabi.