On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets such as Germany and France to follow, and additional European rollouts to occur in 2026.
Afqlir® was the second aflibercept biosimilar approved in Europe in November 2024 and received marketing authorisation in the UK in January 2025. It is approved for all indications of Eylea® and is available in a 2 mg vial kit and pre-filled syringe for intravitreal injection.
The European launch of Afqlir® follows the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept). It is expected that other European aflibercept biosimilar launches will be announced shortly.
Aflibercept biosimilars currently approved in Europe include Biocon’s Yesafili® (September 2023), 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). Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.
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®.