Samsung Bioepis said it has reached a licensing and settlement agreement with Regeneron Pharmaceuticals Inc. and Bayer AG covering its biosimilar version of Eylea, clearing the way for launches across major global markets outside the U.S. and Canada.
The agreement αφορά Opfobiz, Samsung Bioepis’s biosimilar to Eylea (active ingredient: aflibercept), a leading treatment for retinal diseases. Under the deal, Samsung Bioepis obtained rights related to the low-concentration formulation of aflibercept, at 40 milligrams per milliliter, in all regions except the U.S. and Canada.
The company said on Jan. 30 (local time) that the agreement allows it to begin marketing the product in the U.K. starting in January 2026, followed by European Union countries in April 2026, and other global markets excluding South Korea in May 2026.
SB15, the biosimilar’s development code name, received approval from the European Commission in 2024. In South Korea, it was approved under the brand name Afillibu and launched in May 2024.
Eylea, the reference biologic developed by Regeneron and marketed globally with Bayer outside the U.S., is widely used to treat wet age-related macular degeneration and other retinal disorders. The drug generated about $11 billion in global sales in 2024, underscoring the commercial significance of biosimilar competition.
Linda Choi, executive vice president and head of the commercial division at Samsung Bioepis, said the agreement would improve patient access to treatments for eye diseases and expand supply across Europe and other international markets.
“This settlement represents an important step toward broadening access for patients with ophthalmic conditions,” Ms. Choi said, adding that the company would continue working to ensure its biologic medicines are more widely available to healthcare systems, physicians and patients worldwide.
Samsung Bioepis, a biosimilars arm of Samsung Group, has been expanding its global portfolio as regulators and healthcare systems seek lower-cost alternatives to blockbuster biologic drugs amid rising medical spending.
