Samsung Bioepis seeks Europe approval for copy of Herceptin breast cancer drug

3 October 2016 - South Korea's Samsung Bioepis, a maker of cheaper copies of complex biotech drugs known as biosimilars, is seeking regulatory approval in Europe to sell its copy of Swiss giant Roche's blockbuster breast cancer drug Herceptin (trastuzumab).

Samsung Bioepis, part of South Korea's top conglomerate Samsung Group, said in a statement on Tuesday the EMA has accepted for review its application to sell its biosimilar of Herceptin. Roche recorded sales of the drug totaling 3.4 billion Swiss francs ($3.49 billion) in first-half 2016.

Interest in biosimilars has soared in recent years as copies of some of the world's best-selling medicines have hit the market at big discounts. Bioepis said it submitted the Herceptin biosimilar application - its first copy of a cancer drug to be submitted for regulatory approval in Europe - in August.

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Michael Wonder

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Michael Wonder