On 10 October 2025, Celltrion announced that the FDA has approved Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), for treating nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy. The launch date for the product remains uncertain given pending BPCIA litigation brought by Regeneron against Celltrion regarding Eydenzelt®.
Eydenzelt® is the sixth aflibercept (2mg) 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, the following proceedings have 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.
Preliminary injunctions were granted, and remain in place, preventing US biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).
Eydenzelt® was the fifth approved aflibercept biosimilar in Europe, in February 2025 (but has not yet launched), and received Korean approval in May 2024. In Australia, Eydenzelt® was approved solely for myopic CNV on 31 March 2025. However, in July 2025, Celltrion filed an application with the TGA to expand Eydenzelt®’s indications to all those of Eylea®. Eydenzelt® will be considered for reimbursement at the November 2025 meeting of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC).