Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission has approved Mynzepli^® as a biosimilar to Eylea^® (aflibercept), in a pre-filled syringe and vial.

"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," said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.

Nick Warwick, Chief Medical Officer of Advanz Pharma, said “The approval of Mynzepli^® marks an important milestone in our mission to broaden access to high-quality and affordable medicines for patients across Europe.”

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 US$9 billion, and one third of these sales were in Europe [1].

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^® [1]. 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.