On 20 October 2025, Regeneron announced that it has settled its BPCIA litigation with Celltrion in relation to Eydenzelt®/CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg). Under the terms of the settlement, Celltrion is permitted to launch Eydenzelt® in the US on 31 December 2026.
The settlement follows FDA approval of Eydenzelt® on 10 October 2025. This was the sixth aflibercept biosimilar to be approved in the US following: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu® (August 2024) Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024).
Amgen’s Pavblu® is the only aflibercept biosimilar to have launched in the US, in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen. Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu® (June 2025), which remains pending.
Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigation brought by Regeneron. However, in addition to the Regeneron/Celltrion proceedings, the following litigation has now settled, with biosimilar launches scheduled for 2026:
- Biocon and Regeneron settled BPCIA litigation in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026 (or earlier under certain undisclosed circumstances); and
- Sandoz’s Enzeevu™ and Formycon’s Ahzantive® are set to launch in Q4/2026 (or earlier under certain undisclosed circumstances) after settlement and licence agreements were announced in September 2025 and October 2025, respectively.
A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of biosimilar aflibercept (14 June 2024, upheld on appeal on 29 January 2025).