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

SEOUL (Reuters) - 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.

Samsung Bioepis, part of South Korea’s top conglomerate Samsung Group [SAGR.UL], said in a statement on Tuesday the European Medicines Agency (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.

As of end-June, Bioepis was 91.2 percent owned by Samsung BioLogics, which separately on Tuesday announced plans for an initial public offering that could raise up to 2.25 trillion won ($2 billion). BioLogics is controlled by Samsung Group’s de facto holding company Samsung C&T Corp and Samsung Electronics Co Ltd.

U.S. biopharmaceuticals maker Biogen Inc is a minority shareholder in Bioepis with an 8.8 percent stake as of end-June.

Bioepis, which seeks to be first or second to market with its products, received European regulatory approval earlier this year to sell copies of Amgen Inc’s Enbrel and Johnson & Johnson’s Remicade - two blockbuster rheumatoid arthritis drugs.

It is also seeking European approval for its biosimilar of arthritis treatment Humira, the world’s top-selling drug.

Reporting by Se Young Lee; Editing by Muralikumar Anantharaman and Kenneth Maxwell