On 12 February 2026, Samsung Bioepis announced that it has entered a settlement and licence agreement with Regeneron in relation to commercialisation of Opuviz™ (SB15), biosimilar to Regeneron’s Eylea® (aflibercept), in the US. Under the terms of the agreement, Samsung Bioepis can launch Opuviz™ (US approved in May 2024) in the US from January 2027.
The settlement resolves BPCIA litigation pending between the companies. On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching Opuviz™ in the US without a licence from Regeneron. This affirmed an earlier decision in June 2024 (US District Court -Northern District of West Virginia), finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.
In January 2026, the companies struck an EU/ROW deal permitting launch of SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement (excluding Korea where it is already on the market) from May 2026.
Only a single biosimilar competitor to Regeneron’s Eylea® is currently on the market in the US; Amgen’s Pavblu®, launched October 2024. 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).