Celltrion seeks FDA approval for biosimilar Remsima

FDA

Celltrion Inc., which sells a cheap version of a top-selling rheumatoid arthritis drug in Europe, is now setting its sights on the U.S., the world’s biggest pharmaceutical market. 

Stanley Hong, chief executive of the South Korean company’s distribution and marketing unit, Celltrion Healthcare Co., said in a recent interview it will start shipping its so-called biosimilar form of Johnson & Johnson and Merck & Co.’s Remicade to the U.S. later this year upon getting approval from the Food and Drug Administration.

Biosimilars or less expensive versions of complex biologic treatments used to treat cancer and other serious diseases, are of growing interest as patents expire on some older, high-priced antibody drugs, which are among the pharmaceutical industry’s biggest sellers. In Europe, biosimilars have been on sale for several years, but the debut of lower-priced copies of biotech drugs in the U.S. have been slow, partly due to safety concerns and opposition from brand drug makers. Last month, however, the FDA approved the first copy of a biotechnology drug, Zarxio from Novartis AG, for the U.S. market. It is prescribed to chemotherapy patients and the approval introduced competition for costly biotech medicines.

For more details, go to: http://www.wsj.com/articles/celltrion-seeks-fda-approval-for-biosimilar-remsima-1427869990?tesla=y

Michael Wonder

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Michael Wonder

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