On 18 February 2025, Alvotech and Teva announced that the US FDA has accepted for review a Biologics Licence Application (BLA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg). The companies expect that regulatory approval will be obtained in Q4/2025.
Alvotech and Teva’s partnership commenced in August 2020 for the commercialisation of 5 biosimilars in the US and has subsequently expanded. In addition to AVT06, Alvotech is also developing AVT29, biosimilar to Regeneron’s Eylea HD® (aflibercept, 8 mg). Teva also holds commercialisation rights for AVT29 in the US.
There are currently five aflibercept (2 mg) biosimilars approved in the US: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024). Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.
On 15 August 2024, Alvotech and its European commercialisation partner, Advanz Pharma announced that the European Medicines Agency (EMA) had accepted a Marketing Authorisation Application (MAA) for AVT06, with marketing authorisation expected to be granted in Q3 2025.