On 19 December 2025, Alvotech and Teva jointly announced that they have reached a settlement and licence agreement with Regeneron regarding the US launch of Alvotech’s AVT06, biosimilar to Regeneron’s Eylea® (aflibercept). Under the agreement, Alvotech/Teva are permitted to launch AVT06 in Q4 of 2026, or earlier under certain undisclosed circumstances.
A Biologics Licence Application for AVT06 was accepted by the FDA for review in February 2025. By way of a partnership commenced in August 2020, Teva holds the US commercialisation rights for AVT06.
Only a single biosimilar competitor to Regeneron’s Eylea® is currently on the market in the US; Amgen’s Pavblu®, launched October 2024. However, there are a number of approved aflibercept biosimilars, some of which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026) and Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026). A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of Opuviz® (14 June 2024, upheld on appeal on 29 January 2025).
AVT06 was approved in the EU and UK in August 2025, as Mynzepli®, and in Japan in September 2025.
In November 2025, Alvotech succeeded in defending Regeneron/Bayer’s request for an injunction from the UK High Court to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to AVT06. This ruling cleared 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.