UK High Court Rules in Favor of Alvotech Paving Way for Manufacture and Market Entry of AVT06, biosimilar to Eylea® (aflibercept)         

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[{"type":"text","content":"REYKJAVIK, ICELAND (November 10, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the outcome of expedited infringement proceedings before the UK High Court by Regeneron Pharmaceuticals Inc. (“Regeneron”) and Bayer AG (“Bayer”) against Alvotech and its contract manufacturing organization (CMO) in the United Kingdom. The court rejected Regeneron’s and Bayer’s injunction request in relation to manufacturing activities at Alvotech’s CMO in the UK for Alvotech’s biosimilar to Eylea® (AVT06). The decision will support commercial launches of Alvotech’s biosimilar in the European Economic Area, the UK and other countries after the expiry date for Supplementary Protection Certificates (SPCs) for Eylea®, which is November 23, 2025. “The outcome of this case was never in doubt in my mind, but we are of course very pleased to have obtained this decision by the UK High Court. This will allow Alvotech to proceed with its manufacturing activities and supports bringing our biosimilar to Eylea to patients and caregivers in Europe and the rest of the world,” said Robert Wessman chairman and CEO of Alvotech. “It took years to put an SPC waiver system in place, and it is very important for European biosimilars manufacturers that the waiver system is functional and not abused. An important objective is to bring biosimilars production and jobs back into Europe. This decision by the UK High Court is therefore not only a victory for Alvotech and its partners, but also for patients and caregivers in Europe and in the rest of the world who need better access to quality biologics.” The case focused on the issue of an SPC waiver exempting certain acts of third-party manufacturers from infringement. The SPC regulation provides that SPCs should not block manufacturing of biosimilars for stockpiling during six months before the SPC expiry, in support of product launches in the European Economic Area and the UK, as well as export to countries outside this region during the lifetime of the SPC. The decision of the UK High Court means that Alvotech and its CMO can continue to manufacture and store AVT06 in the UK, for later distribution in the UK, EEA and rest of the world. Alvotech announced on August 21, 2025, that the European Commission h...

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