Alvotech and its commercial partner Advanz Pharma have announced that the European Commission has granted marketing authorisation for Mynzepli (aflibercept), a biosimilar to Eylea, available in both pre-filled syringes and vials.

The approval covers all European Economic Area (EEA) member countries, including the EU’s 27member states as well as Norway, Iceland, and Liechtenstein.

Mynzepli is now authorised for the treatment of several retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME), and myopic choroidal neovascularization (myopic CNV). It will be available as a 40 mg/mL solution for injection in a pre-filled syringe and in a vial.

The approval was based on a comprehensive set of analytical, non-clinical, and clinical similarity data, including a confirmatory Phase III trial comparing Mynzepli (previously AVT06) with the reference biologic Eylea in patients with neovascular AMD. The study demonstrated therapeutic equivalence, meeting its primary efficacy endpoint and confirming similar safety and immunogenicity profiles.

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

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

Eylea, jointly developed by Regeneron and Bayer, generated approximately USD 9 billion in global sales in 2024, with nearly one-third of revenues coming from Europe.

The European Commission’s decision to issue a marketing authorisation came after the European Medicine Agency (EMA)’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.

Based in Reykjavík, Iceland, Alvotech is a global biotech company specialising in the development and production of biosimilars, while Advanz Pharma, headquartered in the UK, focuses on specialty, hospital, and rare disease medicines in Europe.