Samsung Bioepis announced on the 12th that it has entered into a patent license agreement with the original developer regarding its low-dose (2mg) Eylea biosimilar, Opuviz (ingredient name: aflibercept).
The ophthalmic treatment Eylea, co-developed by Regeneron Pharmaceuticals in the U.S. and Bayer in Germany, is a blockbuster drug projected to generate approximately 13 trillion won in global sales in 2024. While the core substance patent for the drug has already expired, secondary formulation patents in major markets like the U.S. and the European Union (EU) are set to remain in effect until June 2027. Without a formal agreement or a successful patent challenge, biosimilars would be blocked from market entry despite receiving regulatory approval.
Through this settlement, Samsung Bioepis has secured the rights to launch Opuviz in the U.S. market in January 2025. Coupled with a similar patent agreement reached in January for the EU and other territories, the company is now positioned for a sequential global rollout.
Kris (Kyung-ah) Choe, Head of the Commercial Division at Samsung Bioepis, stated, “This agreement resolves all patent disputes worldwide related to our low-dose (2mg) Eylea biosimilar, establishing a clear path for our product launch. We remain committed to expanding patient access to essential biopharmaceuticals.”
Opuviz received approval from the U.S. Food and Drug Administration (FDA) in May 2024. In South Korea, the product was approved under the brand name Afilibu and launched earlier this year.
