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Biosimilar Brenzys receives approval in South Korea

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Merck and Samsung Bioepis have announced the approval of Brenzys, a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety in South Korea. Brenzys is indicated for treatment of rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis and psoriasis in patients 18 years old and older.

“We are excited by the opportunity to deliver on the promise of biosimilars overall – and on the promise of Brenzys – by combining Merck’s deep global customer expertise with the extensive development and manufacturing capabilities of Samsung Bioepis,” Dora Bibila, general manager of Merck Biosimilars, stated in a company release.  

Christopher Hansung Ko, chief executive officer of Samsung Bioepis, stated, “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.”

According to the release, the approval is the first in Merck’s partnership with Samsung Bioepis. Merck plans to launch Brenzys in South Korea by early 2016.