On 23 June 2025, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).
AVT06 is indicated for the treatment of adults with nAMD, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
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®.
There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), 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) and Amgen’s Pavblu® (April 2025).
Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025. A number of aflibercept (2mg) biosimilars are also awaiting European Commission approval, including STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli® (positive CHMP opinions adopted in June 2025).
In February 2025, Alvotech’s AVT06 BLA was accepted in the US, where it is to be commercialised by Teva. Alvotech and Teva are expecting that regulatory approval from the FDA will be obtained in Q4 2025.