(image: Samsung Biologics)
SEOUL, Jul. 25 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Tuesday that its biosimilar drug Renflexis was launched in the United States following the approval of the U.S. Food and Drug Administration (FDA).
In April, the FDA approved Renflexis — a biosimilar referencing Janssen Biotech, Inc.’s blockbuster immunology medicine Remicade — marking the first time that a product made by Samsung Bioepis has been given the green light to be marketed in the U.S., the company said.
The drug will be introduced in the U.S. at a list price of US$753.39, representing a 35 percent discount to the current list price of Remicade, sources added.
The move came more than a year after South Korea’s Ministry of Food and Drug Safety approved Renflexis for treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriatic arthritis.
Samsung Bioepis — a joint venture between Samsung Biologics and Biogen Inc. — also won approval for Renflexis from authorities in Europe and Australia last year. Samsung BioLogics is a biopharmaceutical unit of South Korea’s top conglomerate Samsung Group.
(Yonhap)
