SEOUL (Reuters) – South Korean biosimilars maker Samsung Bioepis Co Ltd said on Tuesday it has applied to the U.S. Food and Drug Administration (FDA) for approval to sell its version of blockbuster drug Remicade in the world’s biggest healthcare market.
The drug is the first biosimilar submitted for regulatory approval in the United States by Samsung Bioepis, controlled by Samsung Group [SAGR.UL]. The FDA has accepted the application for review, Bioepis said.
Biosimilars are lower-cost copies of complex biotech drugs that have already gained regulatory approval.
Remicade is Johnson & Johnson’s rheumatoid arthritis drug with $6.6 billion in sales last year. Bioepis’ version of it received the European Medicines Agency’s recommendation for approval in April.
The FDA last month approved a Remicade biosimilar developed by South Korea’s Celltrion Inc to treat various diseases including rheumatoid arthritis and Crohn’s disease.
May 23, 2016