Samsung Bioepis's Opuviz gets EC approval

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Samsung Bioepis's Opuviz gets EC approval

Published: 19 Nov. 2024, 15:30 Updated: 19 Nov. 2024, 15:53

LEE JAE-LIM
[email protected]

Samsung Bioepis's headquarters in Songdo, Incheon [SAMSUNG BIOEPIS]

Samsung Bioepis’s biosimilar product Opuviz has been approved by the European Commission, according to the Korean biosimilar developer on Tuesday.

It is the second ophthalmological drug approved in Europe and fifth biosimilar lineup developed by the company under partnership with Massachusetts-based biotech company Biogen.

Opuviz, which references Regeneron Pharmacueticals’ vision loss inhibitor Eylea, treats wet age-related macular degeneration, diabetic macular edema and macular edema due to vein occlusion, as well as myopic choroidal neovascularization.

Commercialization rights are held by Biogen, the Korean developer’s partner in charge of local marketing and sales of its biosimilar products in overseas markets.

“Retinal disorders affect millions of people’s lives in Europe, yet many patients face barriers to treatment due to high costs,” said Jung Byoung-in, vice president of regulatory affairs at Samsung Bioepis. “The EC approval for Opuviz represents a major step toward our goal of expanding access to vital biologic therapies for those in need.”

Opuviz was approved for commercialization by the U.S. Food and Drug Administration in May. It received domestic approval in February and is distributed in Korea through Samil Pharmaceutical.

BY LEE JAE-LIM [[email protected]]