Alvotech files AVT29 biosimilar application
- Alvotech (NASDAQ:ALVO) and Advanz Pharma submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg.
- The application was filed with the European Medicines Agency as a line extension to Alvotech’s existing Mynzepli marketing authorization.
- Alvotech said AVT29 remains investigational and regulators have not yet confirmed its biosimilarity to Eylea 8 mg.
Alvotech (NASDAQ:ALVO) and Advanz Pharma submitted a regulatory application in Europe for AVT29, a proposed biosimilar referencing Eylea 8 mg, a treatment used for retinal diseases.
The submission was made to the European Medicines Agency as a line extension of Mynzepli, Alvotech’s approved biosimilar to Eylea 2 mg, which received European Commission approval in August 2025.
Under their agreement, Alvotech is responsible for AVT06 and AVT29 development and commercial supply, while Advanz Pharma manages European registration and commercialization activities.
Eylea 8 mg has approved European dosing information allowing 16-week treatment intervals for certain patients, compared with the standard eight-week maintenance interval for the original 2 mg formulation.
Alvotech develops biosimilar medicines, while Advanz Pharma focuses on specialty pharmaceutical products across European and international markets.
