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Korea approves Samsung's first biosimilar

The approval represents the first product approval under Merck’s collaboration with Samsung Bioepis.

The Ministry of Food and Drug Safety in Korea approved BRENZYS, a biosimilar of the immunology medicine Enbrel, for the treatment of, among other things, rheumatoid arthritis, according to a company press release.

The approval of BRENZYS in Korea represents the first product approval under Merck’s collaboration with Samsung Bioepis, which is designed to offer high-quality biosimilar alternatives to existing biologic medicines to help address patient and healthcare system needs worldwide. Merck plans to launch BRENZYS in South Korea by the end of this year or early next year.

Merck and Samsung Bioepis announced in February 2013 a collaboration to develop and commercialize, in certain partnered territories, multiple biosimilar candidates.

“We are very excited to receive this first regulatory approval of a biosimilar product resulting from our late-stage development pipeline,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “The approval of BRENZYS in Korea is especially gratifying, and underscores our commitment to advancing healthcare through innovation and groundbreaking technology. We look forward to building on this progress in our collaboration with Merck.”

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