On 21 August 2025, Alvotech and Advanz Pharma announced that Mynzepli® (AVT06), biosimilar to Regeneron/Bayer’s 2mg Eylea® (aflibercept) has been approved by the European Commission in pre-filled syringe and vial presentations. Mynzepli® received a positive CHMP opinion in June 2025 and is approved across all Eylea® indications.
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®.
In February 2025, Alvotech’s AVT06 BLA was accepted in the US, where it will be commercialised by Teva. Alvotech and Teva are expecting FDA approval in Q4 2025.
There are 8 other aflibercept (2mg) biosimilars approved in Europe, none of which have launched to date: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025). Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.