UK High Court Clears Path for Alvotech's Eylea Biosimilar Manufacturing Ahead of Patent Expiry
核心洞察
The UK High Court rejected Regeneron and Bayer's injunction request against Alvotech's manufacturing of AVT06, a biosimilar to Eylea (aflibercept), allowing continued production at the company's UK contract manufacturing organization.
The court decision supports commercial launches of AVT06 in the European Economic Area, UK and other countries after the Supplementary Protection Certificate expiry on November 23, 2025.
AVT06 has already received regulatory approval from the European Commission on August 21, 2025, and the UK MHRA on August 28, 2025, with dossiers under review in multiple countries including the United States.
The UK High Court has rejected an injunction request from Regeneron Pharmaceuticals and Bayer AG against Alvotech's manufacturing activities for AVT06, its biosimilar to the blockbuster eye drug Eylea (aflibercept). The November 10, 2025 ruling clears the way for Alvotech to continue manufacturing and storing the biosimilar at its UK contract manufacturing organization ahead of the Supplementary Protection Certificate (SPC) expiry on November 23, 2025.
Court Upholds SPC Waiver System
The expedited infringement proceedings centered on the SPC waiver exemption that allows third-party manufacturers to produce biosimilars for stockpiling during the six months before SPC expiry. This regulatory provision supports product launches in the European Economic Area and UK, as well as exports to countries outside the region during the SPC lifetime.
"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," said Robert Wessman, chairman and CEO of Alvotech. "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."
Regulatory Approvals Already Secured
AVT06 has already received key regulatory approvals, with the European Commission approving the biosimilar for marketing in the European Economic Area on August 21, 2025. The UK Medicines and Healthcare products Regulatory Agency (MHRA) followed with approval for UK marketing on August 28, 2025. The biosimilar has also been approved in Japan, and dossiers are currently under review in multiple countries globally, including the United States.
Mechanism of Action and Clinical Applications
AVT06 is a recombinant fusion protein that binds vascular endothelial growth factors (搜索) (VEGF (搜索)), inhibiting the binding and activation of VEGF receptors (搜索), neovascularization, and vascular permeability. This mechanism of action makes it effective for treating various eye disorders (搜索) where abnormal blood vessel growth contributes to vision loss.
Strategic Impact on Biosimilar Manufacturing
Wessman emphasized the broader implications of the court decision for European biosimilar manufacturing: "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."
The CEO characterized the ruling as "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."
Commercial Partnership Network
Alvotech has established an extensive network of strategic commercial partnerships to provide global reach and leverage local expertise across multiple markets. The company's commercial partners include Teva Pharmaceuticals in the US, STADA Arzneimittel AG in the EU, Fuji Pharma Co., Ltd in Japan, and numerous other partners covering regions including China, South America, Africa, and the Middle East.
Company Pipeline and Market Position
The Iceland-based biotech company, founded by Robert Wessman, focuses solely on developing and manufacturing biosimilar medicines. Alvotech already has two biosimilars approved and marketed in multiple global markets: biosimilars to Humira (adalimumab) and Stelara (ustekinumab). The current development pipeline includes nine disclosed biosimilar candidates targeting autoimmune disorders (搜索), eye disorders (搜索), osteoporosis (搜索), respiratory disease (搜索), and cancer (搜索).