Samsung’s Biotech Unit Is Seeking Europe Approval for Its Copy of This Drug

October 4, 2016, 3:51 AM UTC
Herceptin Approved For Treatment Of Scottish Breast Cancer Patients
EDINBURGH, UNITED KINGDOM - JUNE 09: Stocks of the drug Herceptin are displayed in the satellite pharmacy at the Western General Hospital June 9, 2006 in Edinburgh, Scotland. The drug is to be made available on the NHS in Scotland for all women with early forms of breast cancer. (Photo by Jeff J Mitchell/Getty Images)
Jeff J Mitchell/Getty Images

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, said in a statement on Tuesday the European Medicines Agency (EMA) has accepted for review its application to sell its biosimilar of Herceptin. Roche (RHHBY) recorded sales of the drug totaling 3.4 billion Swiss francs ($3.49 billion) in first-half 2016.

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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% 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 (SAMSUNG-CT) and Samsung Electronics (SSNLF).

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U.S. biopharmaceuticals maker Biogen (BIIB) is a minority shareholder in Bioepis with an 8.8% 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’s (AMGN) Enbrel and Johnson & Johnson’s (JNJ) 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.

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