Image source: © 2025 Krish Capital Pty.Ltd

Highlights

  • European Commission grants centralized marketing authorisation for Mynzepli as an aflibercept biosimilar.
  • Approval covers all adult indications of the reference biologic, with syringe and vial presentations.
  • 2024 reference product sales were about USD9 billion; Europe accounted for roughly one-third.

Alvotech (NASDAQ: ALVO) and Advanz Pharma Holdco Limited said the European Commission has approved Mynzepli® as a biosimilar to Eylea® (aflibercept). The approval is a centralized marketing authorisation that covers all European Economic Area (EEA) countries — the 27 EU member states plus Norway, Iceland and Liechtenstein — and applies to both a 40 mg/mL pre-filled syringe and a 40 mg/mL vial.

Mynzepli is approved for the same adult indications as the reference biologic: neovascular (wet) age-related macular degeneration (AMD); visual impairment due to macular oedema secondary to retinal vein occlusion (branch or central RVO); diabetic macular oedema (DME); and myopic choroidal neovascularization (myopic CNV). The companies said Mynzepli completed the regulatory review process that substantiated biosimilarity to the reference product.

From a market perspective, Eylea® posted global sales of about USD9 billion in 2024, with roughly one third of those sales occurring in Europe. That scale makes the European ophthalmology market a commercial focus for any new entrant, although actual uptake of a biosimilar depends on national reimbursement decisions, hospital procurement practices, and prescriber behaviour.

The approval shifts the discussion to next-stage commercial and operational matters. Key considerations for stakeholders will include manufacturing scale-up, national marketing authorisations or formulary listings where required, pricing and tender outcomes, and agreements with hospital systems and specialist clinics. Biosimilar uptake in ophthalmology has historically varied across European markets, influenced by policy measures, switching guidance, and clinician acceptance.

Alvotech’s statement emphasised the role of wider access to therapies for retinal disease, and Advanz noted the strategic fit with its specialty and hospital-focused portfolio in Europe. Regulators’ biosimilarity findings do not imply interchangeability or automatic substitution in every jurisdiction; local rules will determine substitution and switching pathways.