Samsung Bioepis reached a settlement with the global corporations Regeneron and Bayer, which developed the original ophthalmology drug Eylea, opening the way to sell a biosimilar outside the United States and Canada.
Samsung Bioepis, a subsidiary of Samsung Epis Holdings, said on the 30th that it signed a Settlement and License Agreement with original drug companies Regeneron and Bayer covering sales of the low-dose formulation (40 mg/mL) of SB15 (brand name Opuviz, ingredient aflibercept) outside the United States and Canada.
Eylea is a macular degeneration treatment co-developed by U.S.-based Regeneron and Germany's Bayer. It is a blockbuster drug that recorded global sales of $9.523 billion (about 13.6 trillion won) in 2024. Macular degeneration is a disease in which cells in the macula, the center of the retina, age and vision declines, and Eylea treats it by blocking the formation of new blood vessels around the macula.
Regeneron and Bayer, which split the U.S. rights and global rights outside the United States, have pursued a patent defense strategy against biosimilars. As a result, the global launches of biosimilar developers, including Samsung Bioepis, were impeded.
Under the agreement, Samsung Bioepis said it can launch SB15 in the United Kingdom (in Jan. 2026), in European countries (in Apr. 2026), and in other countries excluding Korea (in May 2026). SB15 received approval from the European Commission (EC) in 2024. In Korea, it was approved under the brand name afilivu and launched in May 2024, with domestic sales handled by Samil Pharmaceutical.
Vice President Linda Choi, head of commercial at Samsung Bioepis, said, "This agreement will be an important opportunity to improve treatment access for ophthalmology patients," and added, "We will expand the supply of SB15 in Europe and global markets."
Meanwhile, the only company actually selling an Eylea biosimilar in the U.S. market now is Amgen. Amgen began sales in Oct. 2024 by pursuing a strategy that avoided existing patents. Regeneron sued Amgen again based on new patents, while Amgen countered with an antitrust countersuit.
Celltrion, which received U.S. Food and Drug Administration (FDA) approval for the Eylea biosimilar "Eydenzelt" in Oct. last year, reached a settlement with Regeneron and will be able to sell it in the United States starting late this year. In Europe, after winning European Commission (EC) approval in Feb. last year, the company has been expanding launches sequentially to major countries including the United Kingdom. However, in Germany recently, a formulation patent was found to be infringed and sales were banned, and additional settlement talks are underway.