On 8 October 2025, judgment was published in patent infringement proceedings brought by Regeneron/Bayer in the UK seeking to prevent Samsung Bioepis and Formycon/Klinge from launching biosimilars to Regeneron/Bayer’s Eylea® (aflibercept) in the UK after the November 2025 expiry of a supplementary protection certificate for the patent on aflibercept (EP 1 183 353). Mr Justice Meade of the High Court of Justice of England and Wales found that Formycon/Klinge’s and Samsung Bioepis’ aflibercept biosimilars did not infringe either of the patents asserted by Regeneron (EP (UK) 2 364 691 and EP (UK) 2 944 306) and held that the ‘306 patent was invalid (for added matter).
The asserted ‘691 and ‘306 patents each relate to formulations of aflibercept for intravitreal use. Neither Formycon/Klinge’s nor Samsung Bioepis’ products possess all the formulation features of the claims in that they use a different excipient from the one claimed and/or they omit one of the claimed excipients and/or they use a different amount of an excipient from that claimed in the patents. Regeneron accepted that there was no literal infringement but argued that there was infringement by equivalence in each case. The Court rejected this argument, holding that all allegations of infringement by equivalence failed.
The Court has scheduled a hearing on the form of orders to be made (unless the parties can agree) on 7 November 2025. No appeal can be filed until after that time.
Subject to any successful appeal, the decision clears the way for a November 2025 launch of Formycon/Klinge’s aflibercept biosimilar, Ahzantive®/FYB203, which was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025. Samsung Bioepis’ Opuviz®/SB15 has not yet been approved in the UK, but was approved in Europe in November 2024.