On 10 November 2025, Alvotech announced that the UK High Court has rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s AVT06 (Mynzepli®), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).
The ruling clears the way for pre SPC expiry UK manufacturing activities to progress enabling the “day 1” (post SPC expiry) launch of AVT06 in the UK, Europe and other countries following the expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept) on 23 November 2025.
Regeneron/Bayer commenced the legal proceedings against Alvotech and its UK contract manufacturing organisation (CMO), Fisher Clinical Services, in September 2025. The case focused on the operation of the SPC Manufacturing Waiver, which exempts third party manufacturing activities from patent infringement on certain conditions, including regarding notification to the patent holder.
Regeneron/Bayer argued that Alvotech’s UK waiver notice was deficient in that it had not identified details of the country of export at the time of providing the waiver notice. Justice Meade of the UK High Court rejected this argument from the bench during the hearing on 4 November 2025 (with judgment to be subsequently published).
As a result, Alvotech and Fisher can continue to manufacture and store AVT06 in the UK pre SPC expiry, for distribution in the UK, to EEA and ROW.
Mynzepli® was approved by the European Commission in August 2025 across all Eylea® indications, in pre-filled syringe and vial presentations, following a positive CHMP opinion in June 2025. The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved AVT06 on 28 August 2025.
Alvotech has partnered with Advanz Pharma for the commercialisation of Mynzepli® in the UK and Europe. Under a June 2024 agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive.