Alvotech And Advanz Pharma Secure European Commission Approval For Mynzepli®, Alvotech’s Biosimilar To Eylea®

Alvotech, a global biotechnology company focused on biosimilars, and Advanz Pharma, a UK-based pharmaceutical company specializing in specialty and rare disease medicines, announced that the European Commission (EC) has approved Mynzepli®, a biosimilar to Eylea® (aflibercept). The approval covers both pre-filled syringe and vial presentations.

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 across the entire European Economic Area (EEA), including all 27 EU member states, Norway, Iceland, and Liechtenstein. Eylea® recorded global sales of approximately US$9 billion in 2024, with Europe accounting for about one-third of that revenue. Mynzepli® is approved for all adult indications of the reference product, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular oedema (DME), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (myopic CNV). 

"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.

This approval follows Alvotech’s successful Phase III confirmatory trial (AVT06) in patients with wet AMD, which demonstrated therapeutic equivalence in efficacy, safety, and immunogenicity compared with Eylea®. The EC’s authorization was based on a prior positive opinion from the European Medicines Agency’s CHMP. Regulatory reviews of AVT06 are also underway in multiple markets worldwide, including the United States and Japan.