Alvotech and Advanz Pharma Submit First Biosimilar Application for Eylea 8 mg
Alvotech and Advanz Pharma have submitted a regulatory application to the European Medicines Agency for AVT29, a proposed biosimilar to Eylea 8 mg. This submission is reportedly the first worldwide for a biosimilar to the high-dose formulation.
Biotechnology firm Alvotech and pharmaceutical company Advanz Pharma have announced the submission of a regulatory application for AVT29 to the European Medicines Agency (EMA). AVT29 is a proposed biosimilar to the high-dose Eylea 8 mg (aflibercept) formulation, used to treat retinal diseases.
The submission was made as a line extension to the existing marketing authorization for Mynzepli® (aflibercept 2 mg), Alvotech's biosimilar to the standard-dose Eylea. Based on publicly available information, this marks the first regulatory submission worldwide for a proposed biosimilar to the 8 mg formulation of aflibercept. The higher-dose formulation allows for potential treatment intervals of 16 weeks, compared to eight weeks for the 2 mg version, which may reduce the treatment burden for patients.
According to company reports, the 8 mg formulation accounted for approximately 57% of combined global Eylea sales by value in the second quarter of 2026, up from 30% in the same period of 2025, indicating a market shift towards higher dosages. Alvotech develops and manufactures AVT29, while Advanz Pharma manages registration and commercialization in Europe.
Mynzepli, Alvotech's biosimilar to Eylea 2 mg, received European Commission approval in August 2025. The companies' partnership agreement outlines Alvotech's development and supply role and Advanz Pharma's commercialization responsibilities in Europe.