On 28 November 2025, Celltrion announced that Health Canada has approved its Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept), for all reference indications, in vial and pre-filled syringe forms.
Eydenzelt® is approved in a number of other regions, including in the US (October 2025), EU (February 2025) and Korea (May 2024). In Australia, Eydenzelt® was approved solely for myopic CNV in March 2025, however, in July 2025, Celltrion filed an application with the TGA to expand Eydenzelt®’s indications to all those of Eylea®. Eydenzelt® was considered for reimbursement at the November 2025 meeting of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), though the outcome has not yet been published.
The Canadian approval strengthens Celltrion’s position in North America following the settlement of US BPCIA litigation between Regeneron and Celltrion in relation to Eydenzelt® in October 2025, the terms of which permit Celltrion to launch Eydenzelt® in the US on 31 December 2026.
Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigations brought by Regeneron. However, the following proceedings have 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 settlements 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).