Global biotechnology company Alvotech S.A. (NASDAQ:ALVO) announced on Thursday that it has entered into a licensing and settlement agreement with US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) and German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY).
This agreement resolves all remaining worldwide patent disputes related to Alvotech's biosimilar to Eylea 2mg (aflibercept 40 mg/mL solution).
Combined with a previously announced agreement granting a fourth-quarter 2026 US licence entry date pending regulatory approval, the company now holds global rights to manufacture and supply the biosimilar to commercial partners. The product is already approved for marketing in the European Economic Area, the UK, and Japan.
Under the settlement, Alvotech and its partners may market the biosimilar in the UK and Canada from 1 January 2026, in Japan excluding the diabetic macular oedema indication from 1 May 2026, and in the European Economic Area and other non-US markets from 1 May 2026, with all approved indications in Japan from 1 November 2026. Commercial partners include Advanz Pharma, STADA, Biogaran, and Fuji Pharma Ltd. The biosimilar is marketed under the names Mynzepli, Afiveg, and Aflibercept BS.
Financial terms of the agreement were not disclosed.
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