Biotechnology company Alvotech SA (NASDAQ:ALVO) and pharmaceutical company Advanz Pharma Holdco Limited announced on Thursday that the European Commission has approved Mynzepli (AVT06) as a biosimilar to Eylea (aflibercept), granting centralised marketing authorisation across all European Economic Area countries.

The approval was based on comprehensive analytical, non-clinical, and clinical similarity data, including a confirmatory efficacy study in patients with neovascular age-related macular degeneration (AMD) that demonstrated therapeutic equivalence to Eylea. Mynzepli is authorised for all adult indications of the reference biologic, including wet AMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularisation.

In 2024, global sales of Eylea totalled approximately USD9bn, with one third of revenues generated in Europe. The launch of Mynzepli is expected to broaden access to more affordable retinal disease treatments across the region.

Mynzepli is a recombinant fusion protein that binds vascular endothelial growth factors (VEGF), thereby inhibiting VEGF receptor activation, neovascularisation, and vascular permeability. Regulatory dossiers for AVT06 are under review in several countries, including the United States and Japan.

The product will be available in both pre-filled syringe and vial formats.