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Samsung Bioepis wins FDA approval for biosimilar

All News 10:58 April 22, 2017

SEOUL, April 22 (Yonhap) -- Samsung Bioepis Co. said Saturday it has won approval from the U.S. Food and Drug Administration to sell its biosimilar in the United States in a move that could heat up competition for immunology medicines.

Renflexis -- a biosimilar of Janssen Biotech, Inc.'s blockbuster immunology medicine Remicade -- is expected to go on sale in the U.S. in about six months through Merck, a global health care company known as MSD outside the U.S. and Canada.

The move came more than a year after South Korea’s Ministry of Food and Drug Safety approved Renflexis for treatment for 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.

Samsung Bioepis is expected to compete with Celltrion Inc., a South Korean bio-pharmaceutical firm, over biosimilars in the U.S. Last year, Celltrion won approval from the FDA to sell Remsima, a biosimilar to Remicade.

Biosimilars are defined by the FDA as products that are "highly similar to an already approved biological product," which has "no clinically meaningful differences in terms of safety and effectiveness from the reference product."


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