Samsung Bioepis cleared for eye treatment biosimilar sales in US
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 posi
Feb 12, 2026By Nam Hyun-woo