Alvotech has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes worldwide related to Alvotech’s biosimilar to Eylea 2mg (aflibercept 40 mg/mL solution), which is approved for marketing in the European Economic Area, United Kingdom (UK) and Japan. In combination with the previously announced agreement which granted a Q4 2026 licence entry date for the US, pending regulatory approval, the company now has worldwide rights to manufacture and supply its global commercial partners with the aflibercept biosimilar.

The settlement agreement allows Alvotech and its commercial partners to market and sell the biosimilar as of 1 January, 2026 in the UK and Canada, as well as in Japan (excluding the diabetic macular edema indication) starting 1 May, 2026 in the European Economic Area and all other countries in the world (other than the US), and from 1 November, 2026 in Japan with all approved indications. The remaining terms of the agreement remain confidential.

“Following our previously announced settlement with the originator for the US market, we are delighted to resolve all outstanding patent-related matters in the rest of the world. Our strong regional commercial partners are now very well positioned for a successful launch. Aflibercept remains the established and widely used treatment for various retinal diseases and we look forward to continuing to support our commercial partners, further advancing the long-term sustainability of global healthcare systems,” said Robert Wessman, Chairman and CEO, Alvotech.

Alvotech’s commercial partners for the Eylea biosimilar in Europe are Advanz Pharma (UK/EEA), STADA (DE) and Biogaran (FR) and for Japan Fuji Pharma. The biosimilar is approved by the European Commission for marketing in Europe under the tradenames Mynzepli and Afiveg. It is approved in the UK by the Medicines & Healthcare products Regulatory Agency (MHRA) under the tradename Mynzepli and in Japan by the Japanese Ministry of Health, Labour and Welfare (MHLW) as Aflibercept BS.