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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 drug Herceptin, made by South Korea's Bioepis Co Ltd.

The European Medicines Agency said on Friday its experts had backed a copy of the drug from Bioepis, a 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 to market in Europe. The Commission, which has the final word on drug approvals in the region, typically follows the experts' advice.

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 <068270.KQ> have also submitted their copies of the drug for approval.

If given the final green light by November, Bioepis will have received four approvals in the 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 <4502.T>, expanding beyond biosimilars.

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

(Editing by Ed Osmond)

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Fri, September 15 2017. 17:43 IST