On 9 September 2025, Sandoz announced that it has settled all US patent disputes with Regeneron relating to Sandoz’s Enzeevu®, biosimilar to Regeneron’s Eylea® (aflibercept). Under the settlement, Sandoz is permitted to launch its biosimilar aflibercept in Q4 2026, or earlier in certain undisclosed circumstances.
Regeneron commenced BPCIA litigation against Sandoz in the US District Court for the District of New Jersey on 26 August 2024, asserting infringement of 46 US patents relating to aflibercept. The Court filing came two weeks after the FDA approved Sandoz’s Enzeevu® (aflibercept-abzv) for treatment of nAMD.
The Sandoz US proceeding was one of many Regeneron US proceedings regarding aflibercept biosimilars.
- Biocon and Regeneron settled US aflibercept BPCIA litigation in April 2025, paving the way for a US launch of Biocon’s biosimilar, Yesafili™, in the second half of 2026, or earlier under certain undisclosed circumstances. Litigation remains pending against Amgen (Pavblu™), Samsung Bioepis (2 actions; Opuviz™/SB15), Formycon (Ahzantive®/FYB203) and Celltrion (2 actions, CT-P42).
- Preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).
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. Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).