On 24 February 2026, Business Korea reported that Fresenius Kabi has settled its aflibercept US patent dispute with Regeneron. The announcement was made in a shareholder notice issued by Sam Chun Dang (SCD), which has licensed its aflibercept biosimilar to Fresenius for US commercialisation. According to the notice, the settlement will permit SCD/Fresenius to launch Vygenfree™/SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), in the US at an undisclosed time. The terms of the settlement are confidential.
Vygenfree™/SCD411 has not yet been approved in the US. The FDA accepted SCD’s application for SCD411 for review in December 2025.
Fresenius was granted the exclusive US commercialisation rights to SCD411 under a licensing agreement with Sam Chun Dang announced in December 2024. SCD is responsible for the development, manufacture and supply of SCD411, while Fresenius has the commercialisation rights for the US, Brazil, Argentina, Chile, Paraguay, Colombia and Mexico.
In 2025, Fresenius sought to challenge the validity of two of Regeneron’s US aflibercept patents (US Patent No. 11,084,865 and US Patent No. 10,828,345) by filing petitions for inter partes review. The PTAB recently denied institution of both petitions.
The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar. However, there are a number of approved aflibercept biosimilars, some of which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026), and Alvotech/Teva’s AVT06 (BLA accepted for review February 2025, due to launch Q4/2026, subject to regulatory approval).