On 13 December 2025, Biocon Biologics announced that it has reached a settlement and licence agreement with Regeneron and Bayer for Yesafili®, biosimilar to Regeneron/Bayer’s Eylea® (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. The settlement follows an April 2025 settlement between the companies covering the US and Canada, which paves the way for a US launch of Yesafili® in H2 2026.
Yesafili® was the first aflibercept biosimilar to receive European marketing approval in September 2023, following a positive CHMP opinion in July 2023. It was approved in the UK in November 2023.
Sandoz’s Afqlir® was the first aflibercept biosimilar to launch in the UK on 24 November 2025, following the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept). At the time, Sandoz announced the launches in major European markets such as Germany and France would follow, with additional European rollouts to occur in 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), Celltrion’s Eydenzelt® (February 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®.