European Commission Approves Mynzepli as a Biosimilar to Eylea

The European Commission has granted marketing authorization for Mynzepli (aflibercept), a biosimilar to Eylea, developed by Alvotech in partnership with Advanz Pharma. 

The centralized authorization applies to all European Economic Area (EEA) countries, including the 27 EU member states, as well as Norway, Iceland, and Liechtenstein. 

Mynzepli has been approved for the same adult indications as the reference biologic, including wet age-related macular degeneration (AMD), visual impairment due to macular edema secondary to branch or central retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV).

The therapy will be marketed as a 40 mg/mL solution for injection, available in both pre-filled syringe and vial formats.

The approval follows positive findings from Alvotech’s AVT06 confirmatory clinical study, announced in January 2024. The trial compared the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with wet AMD, successfully meeting its primary endpoint. Results confirmed therapeutic equivalence between the biosimilar and its reference product.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had previously issued a positive opinion, paving the way for the Commission’s authorization. According to Alvotech, regulatory dossiers for AVT06 are also under review in the US, Japan, and other markets worldwide.