Samsung Bioepis wins EU endorsement for first Herceptin copy

By Joyce Lee and Ludwig Burger

SEOUL/FRANKFURT (Reuters) - European regulators have for the first time recommended approval of a copy of Swiss drugmaker Roche's blockbuster breast cancer drug Herceptin, made by South Korea's Samsung Bioepis Co Ltd.

The European Medicines Agency said on Friday its experts had backed a copy of the drug from Samsung Bioepis, a Samsung Group unit specialising in making cheaper copies of complex biotech drugs known as biosimilars. Healthcare systems and insurers pin hopes of cost relief on the product class.

With the endorsement, Bioepis' version called Ontruzant is set to be become the first Herceptin biosimilar to market in Europe. The EU Commission, which has the final word on drug approvals in the region, typically follows the experts' advice.

Herceptin generated global sales of 6.78 billion Swiss francs ($6.7 billion) in 2016 for Roche.

Competitors, such as Mylan and its Indian partner Biocon as well as South Korea's Celltrion have also submitted their copies of the drug for EU approval.

If given the final green light by November, Samsung Bioepis will have received four biosimilar approvals in the EU in less than two years, including versions of Amgen's Enbrel, Johnson & Johnson's Remicade and AbbVie Inc's Humira, the world's top-selling medicine.

Established in 2012, the relative latecomer to the industry announced last month it will develop multiple original drugs in partnership with Japan's Takeda Pharmaceutical Co Ltd , expanding beyond biosimilars.

In the United States, a decision by the Food and Drug Administration on Biocon and Mylan's biosimilar version of Herceptin was postponed by three months to December, though approval was recommended by an expert panel in July.

(Editing by Ed Osmond)