Samsung Bioepis Reaches Settlement Agreement For Eylea (Aflibercept) Biosimilar In Europe And The Rest Of The World

Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of SB15¹, a biosimilar to Eylea² 2 mg (aflibercept 40 mg/mL solution), in countries excluding the United States and Canada. This agreement enables Samsung Bioepis to launch SB15 in the United Kingdom (UK) from January 2026, in the rest of Europe from April 2026, and in the rest of the settled countries excluding Korea from May 2026.³ The other terms of the agreement remain confidential.

“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 Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, at Samsung Bioepis. “We will continue our efforts to make biologic medicines more accessible to health systems, providers, and patients worldwide.”

Samsung Bioepis’ OPUVIZ (aflibercept 40 mg/mL solution) was approved by the European Commission (EC) in November 2024 and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, www.samsungbioepis.com.

¹ SB15 is the code name for Samsung Bioepis’ biosimilar to Eylea (aflibercept)

² Eylea is a trademark of Bayer AG

³ SB15 is currently available in Korea under the brand name AFILIVU