Samsung Bioepis Completes Global Patent Settlement for Eylea Biosimilar

"Opfuviz" to Launch in the United States in January Next Year

Samsung Bioepis announced on the 12th that it has reached a patent settlement and license agreement in the United States with Regeneron and Bayer, the original developers, regarding the 2 mg formulation of the ophthalmology treatment Opfuviz (ingredient name: aflibercept).

Under this agreement, Samsung Bioepis will be able to launch Opfuviz in the United States starting in January 2027. The company had previously completed a patent settlement in Europe as well. Samsung Bioepis explained that, through this contract, the major global patent disputes related to the 2 mg biosimilar of Eylea have been resolved.

Samsung Bioepis office building in Songdo, Incheon. Samsung Bioepis

Opfuviz received approval from the U.S. Food and Drug Administration (FDA) in 2024. In Korea, it was launched in May 2024 under the product name "Afilivu."

The original drug Eylea is an anti-VEGF therapy indicated for conditions such as wet age-related macular degeneration. Its global sales in 2024 were approximately 14 trillion won. Of this, sales in the United States were estimated at about 9 trillion won.

Linda Choi, Senior Vice President and Head of the Commercial Division at Samsung Bioepis, said, "With this agreement, all patent disputes worldwide related to the 2 mg formulation of Eylea biosimilars have been resolved, establishing a foundation for the launch of our product," adding, "We will continue to make efforts so that patients around the world can more easily use biopharmaceuticals and improve their access to treatment through ophthalmology therapies."

This content was produced with the assistance of AI translation services.