On 16 December 2025, Celltrion announced that it has launched Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in major European countries, including Germany, Portugal and the UK.
Eydenzelt® received European approval in February 2025 for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).
The launch of Eydenzelt® is the second European launch of an aflibercept biosimilar to be announced following the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept). Sandoz’s Afqlir® was the first aflibercept biosimilar to be launched in the UK in late November 2025.
On 13 December 2025, Biocon Biologics announced that it had reached a settlement and licence agreement with Regeneron and Bayer for Yesafili® (aflibercept) in Europe (and ROW), enabling Biocon to launch Yesafili® in the UK in January 2026 and ROW in March 2026, or earlier under certain undisclosed circumstances. A settlement covering the US and Canada was previously agreed between the companies in April 2025, permitting a US launch in H2 2026.
Other aflibercept biosimilars currently approved in Europe include Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).
Litigation will continue to hold up European launches for some biosimilar sponsors. For example, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction preventing Formycon’s launch of its aflibercept biosimilar in 20 countries. The Hague District Court also granted an injunction in October 2025 preventing Samsung Bioepis from launching its aflibercept biosimilar in the Netherlands.
The news has been better for aflibercept biosimilars in the UK, with Samsung Bioepis and Formycon/Klinge defeating injunction applications by Regeneron/Bayer in relation to their aflibercept biosimilars in October 2025. In early November 2025, the UK High Court rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s Mynzepli®.