“Timely access to effective therapies is essential for individuals affected by retinal diseases. With millions of Europeans impacted, the approval of Mynzepli represents important progress in providing innovative and affordable treatment options. This helps to ensure that patients throughout Europe have improved access to vision-preserving care, regardless of financial or logistical barriers,” says Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.

The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 member states of the European Union, as well as Norway, Iceland and Lichtenstein. In 2024, global sales of Eylea were about USD 9 billion, and one third of these sales were in Europe.

Mynzepli

Mynzepli is approved for all adult indications approved for the reference biologic, neovascular (wet) age-related macular degeneration (AMD), or visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) or myopic choroidal neovascularization (myopic CNV). Mynzepli® will be available as a 40 mg/mL solution for injection in a pre-filled syringe and 40 mg/mL solution for injection in a vial.

In January 2024 Alvotech announced positive top-line results from a confirmatory clinical study with its biosimilar candidate to Eylea, known as AVT06, comparing the efficacy, safety, and immunogenicity of the proposed biosimilar to Eylea in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea. The European Commission’s decision to issue a marketing authorization came after the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on approving AVT06, as Mynzepli (aflibercept). Dossiers for AVT06 are currently under review in multiple countries globally, including the United States and Japan.