Samsung Bioepis Reaches Settlement Agreement For Eylea (Aflibercept) Biosimilar In The United States

Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron concerning the commercialization of OPUVIZ (aflibercept-yszy), a biosimilar to Eylea¹ 2 mg (aflibercept), in the United States (US), following an earlier settlement covering Europe and the Rest of the World (RoW)^.2 This agreement enables Samsung Bioepis to launch OPUVIZ 2 mg in the US from January 2027. The other terms of the agreement remain confidential.

“With these two consecutive agreements, we are delighted to resolve all pending patent-related matters relating to our aflibercept biosimilar across the world. We are well-positioned to successfully launch our aflibercept biosimilar 2 mg in approved markets, by working closely with healthcare systems, payers, and providers worldwide,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, at Samsung Bioepis. “Together with ranibizumab, our ophthalmology portfolio will continue to increase accessibility and affordability of biologic medicines for patients living with retinal diseases across the world.”

Samsung Bioepis’ OPUVIZ 2 mg (aflibercept-yszy) was approved by the U.S. Food and Drug Administration (FDA) in May 2024.

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. As a wholly owned subsidiary of Samsung Epis Holdings, 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, visit www.samsungbioepis.com.

¹ Eylea is a trademark of Regeneron Pharmaceuticals

² Samsung Bioepis (Jan 30, 2026). Samsung Bioepis Reaches Settlement Agreement for Eylea (Aflibercept) Biosimilar in Europe and the Rest of the World [News release]. Available at: https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=534¤tPage=1