On 10 September 2025, Regeneron filed a patent infringement suit against Alvotech and Fisher Clinical Services UK Limited in the High Court of Justice for England & Wales. The details of the allegations are not yet publicly available, but the dispute is reported to relate to Alvotech’s aflibercept biosimilar, Mynzepli® (AVT06), biosimilar to Regeneron/Bayer’s Eylea®.
Alvotech partnered with Advanz Pharma for the commercialisation of Mynzepli® into the UK and Europe. Under the June 2024 agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive. 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.
Fisher Clinical Services UK appears to be an end-to-end global clinical supply chain and logistics company based in the United Kingdom.
The UK lawsuit against Alvotech/Fisher was filed a day after Sandoz settled its US aflibercept litigation with Regeneron. Regeneron remains in US BPCIA litigation against each of Amgen (Pavblu™), Samsung Bioepis (2 actions; Opuviz™/SB15), Formycon (Ahzantive®/FYB203) and Celltrion (2 actions, CT-P42) regarding aflibercept biosimilars. Preliminary injunctions were granted preventing US biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).
Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Biocon’s biosimilar, Yesafili™, in the second half of 2026, or earlier under certain undisclosed circumstances.
The only biosimilar aflibercept currently available in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar. Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).
On 3 September 2025, the Federal Court of Australia refused to award Regeneron/Bayer an interlocutory injunction preventing Sandoz from launching its aflibercept biosimilar in Australia.