On 29 January 2026, Alvotech announced a settlement and licence agreement with Regeneron & Bayer in relation to all remaining patent disputes worldwide (excluding the US) concerning Alvotech’s AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg). This follows an earlier settlement between the companies, announced in December 2025, in relation to the US launch of AVT06.
Under the settlements, Alvotech and its commercial partners are permitted to launch AVT06:
- from 1 January 2026, in the UK and Canada, and in Japan (excluding the DME indication);
- from 1 May 2026 in the European Economic Area and all other countries in the world (excluding the US);
- from 1 November 2026 in Japan with all approved indications; and
- in Q4/2026 (or earlier under certain undisclosed circumstances) in the US.
AVT06 was approved in the EU and UK (where it is being commercialised as Mynzepli® by Advanz Pharma), in the EU for commercialisation in Germany as Afiveg® by STADA in September 2025, and in Japan (where it is being commercialised as Aflibercept BS by Fuji Pharma) in September 2025. A Biologics Licence Application for AVT06 was accepted by the FDA for review in February 2025.
In January 2026, the Munich Regional Court granted Regeneron/Bayer a preliminary injunction preventing Alvotech/Advanz Pharma from marketing AVT06 in 21 countries. 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. These proceedings, including any appeals, are now resolved by the settlement.