Samsung Bioepis applies for approval to sell Remicade biosimilar in U.S

May 23, 2016 8:00 PM

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SEOUL 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.

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