Samsung Epis Holdings subsidiary Samsung Bioepis said on the 12th that it signed a settlement and license agreement with U.S.-based Regeneron and Germany's Bayer covering the low-dose (2 mg) formulation of the ophthalmology drug Eylea (ingredient name Aflibercept). With this agreement, all patent disputes related to the low-dose formulation have been resolved.
The product agreed to this time is the same 40 mg/mL (2 mg) low-dose formulation for which sales agreements were finalized in Europe and elsewhere in January. This resolves all patent issues for Samsung Bioepis regarding the Eylea biosimilar low-dose formulation in key markets including the United States and Europe.
Under this agreement, the company will be able to launch the Eylea biosimilar Opuviz in the United States in Jan. 2027.
Eylea is a macular degeneration treatment jointly developed by Regeneron and Bayer. Global sales in 2024 were $9.523 billion (about 13.6 trillion won), and it is a blockbuster drug, with U.S. sales alone reaching about 9 trillion won.
Macular degeneration is a disease in which the macula, the center of the retina, is damaged by aging, leading to decreased vision, and Eylea slows disease progression by suppressing the formation of abnormal new blood vessels around the macula.
Opuviz received U.S. Food and Drug Administration (FDA) approval in 2024 and was approved in Korea under the product name Apilibu, launching in May of the same year.
Linda Choi, head of commercial at Samsung Bioepis (executive vice president), said, "With this agreement, patent issues related to the 2 mg Eylea biosimilar formulation worldwide have been resolved, laying the groundwork for product launches," and added, "We will continue working to improve patients' access to treatment in the ophthalmology field."