On 15 August 2024, Alvotech and Advanz Pharma announced that European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept). The companies expect EMA marketing authorisation to be granted in Q3 2025.
Alvotech and Advanz Pharma entered into an agreement in relation to the European commercialisation of AVT06 in June 2024. Under the agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive. The agreement also covers Alvotech’s AVT29, biosimilar to high-dose (8mg) Eylea®.
This follows Altos Biologics’ MAA submission to the EMA last month for its aflibercept biosimilar, ALT-L9, with marketing approval also expected in 2025. Biocon has received marketing approval for its aflibercept biosimilar (Yesafili®) in the UK (November 2023) and the EU (September 2023), while Formycon’s MAA application for FYB203 (aflibercept) was accepted by EMA in December 2023.