Samsung Bioepis cleared for eye treatment biosimilar sales in Europe, UK

Samsung Bioepis office in Incheon / Courtesy of Samsung Bioepis

Samsung Bioepis has reached a settlement with Regeneron and Bayer over the commercialization of SB15, a biosimilar to eye treatment Eylea, allowing the Korean drug developer to launch the treatment in Europe and the United Kingdom.

According to Samsung Bioepis on Friday, it signed a settlement and license agreement with the two global pharmaceuticals regarding the commercialization of its low-concentration SB15 in countries excluding the United States and Canada.

The agreement allows Samsung Bioepis 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.

The drug, 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.

The remaining task for Samsung Bioepis is to reach a settlement with Regeneron, which holds the U.S. sales rights to Eylea. Regeneron has been striving to maintain its patent protection in the U.S. market, which accounted for more than half of Eylea’s 2024 revenue, as a slew of global biotech companies seek to capture the market.

In Korea, Samsung Bioepis, Celltrion, Alteogen and a number of other drug makers have developed an Eylea biosimilar. Among them, Celltrion will begin U.S. sales of its Eylea biosimilar, called Eydenzelt, by the end of this year, following a settlement with Regeneron.

“This is a significant milestone for patients living with ophthalmic conditions as it paves the way for access to this important biologic medicine in Europe and international markets,” said Samsung Bioepis Executive Vice President Linda Choi MacDonald. “We will continue our efforts to make biologic medicines more accessible to health systems, providers and patients worldwide.”