Nam Hyun-woo has worked as a staff writer at The Korea Times since 2013, mostly covering business and politics. He currently belongs to the Business Desk where he covers topics such as emerging tech, AI, ICT and Korea's chaebol community. Prior to joining the team, he was the paper's correspondent for the presidential office of Korea during the Yoon Suk Yeol and Moon Jae-in administrations.
Samsung Bioepis cleared for eye treatment biosimilar sales in US
Samsung Bioepis headquarters in Incheon / Courtesy of Samsung Bioepis
By Nam Hyun-woo
Samsung Bioepis has reached a settlement with Regeneron over the commercialization of Opuviz, a biosimilar to the latter’s eye treatment Eylea, allowing the Korean drug developer to launch the treatment in the United States.
According to Samsung Bioepis, Thursday, it has signed a settlement and license agreement with Regeneron on launching Opuviz 2 milligram in the U.S. in January next year. The company said the other terms of the agreement remain confidential.
This follows an earlier agreement between the two side over the commercialization of SB15, whose product name in the U.S. is Opuviz, in Europe and the rest of the world. This allowed the company to launch SB15 in the U.K. as of January, in the rest of Europe starting in April and in the remaining countries in the settlement, excluding Korea, starting in May.
Eylea, jointly developed by Bayer and Regeneron, recorded global sales of $9.74 billion in 2024. While the treatment lost patent protection in the United States and Korea in 2024 and in Europe last year, the two pharmaceutical companies have been defending their market position based on formulation and manufacturing process patents valid through June 2027.
Samsung Bioepis’ Opuviz 2 milligram was approved by the U.S. Food and Drug Administration in May 2024.
“With these two consecutive agreements, we are delighted to resolve all pending patent-related matters relating to our aflibercept biosimilar across the world,” Samsung Bioepis Executive Vice President Linda Choi MacDonald said.
“Our ophthalmology portfolio will continue to increase accessibility and affordability of biologic medicines for patients living with retinal diseases across the world.”