UK court ruling clears path for Alvotech’s biosimilar Eylea production

Alvotech, a biotech company based in Iceland, announced that the UK High Court ruled in its favor in an infringement case brought by Regeneron Pharmaceuticals and Bayer AG. The decision permits Alvotech and its UK-based contract manufacturing organization to continue manufacturing AVT06, a biosimilar to Eylea (aflibercept), ahead of its commercial 
launch later this month, according to the company.

The ruling rejected the injunction request from Regeneron and Bayer, clearing the way for Alvotech to produce and store AVT06 under the Supplementary Protection Certificate (SPC) waiver system. The system allows manufacturers to prepare biosimilar products for market entry up to six months before SPC expiration, which for Eylea is Nov. 23, 2025.

Robert Wessman, CEO of Alvotech, said the decision reinforces the intent of the SPC waiver framework, ensuring it functions as intended to support European biosimilar manufacturing and supply. “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,” Wessman said.

The UK Medicines and Healthcare products Regulatory Agency approved AVT06 in August 2025, shortly after the European Commission granted its marketing authorization for the European Economic Area. With the court’s decision, Alvotech said it can now move forward with stockpiling and distribution plans across the UK, EEA, and other global markets following the SPC expiration.

_{This piece was created with the assistance of generative AI tools and was edited by our content team for clarity and accuracy.}