European Commission Grants Marketing Authorization for Aflibercept Biosimilar Mynzepli

Advanz Pharma and Alvotech have announced that the European Commission (EC) has granted marketing authorization for Mynzepli (formerly AVT06), a biosimilar to aflibercept (Eylea; Bayer and Regeneron). The approval allows Mynzepli to be marketed across the European Union and several additional European countries for the treatment of multiple serious retinal diseases.

Indications and Formulation

Mynzepli has been approved in a 40 mg/mL pre-filled syringe and vial formulation. It is indicated for the treatment of several adult retinal conditions, consistent with the reference product aflibercept. These include neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), visual impairment due to macular edema secondary to branch or central retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Market Authorization Scope and Global Regulatory Status

The marketing authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, under the European Economic Area (EEA) framework. Mynzepli is currently under regulatory review in both the United States and Japan.

The approval follows a joint press release by Alvotech, headquartered in Reykjavik, Iceland, and Advanz Pharma, based in London, UK.

Supporting Clinical Data and CHMP Review

In early 2024, Alvotech released positive top-line results from a comparative clinical study evaluating Mynzepli against the reference aflibercept. The study demonstrated equivalent efficacy, safety, and immunogenicity, successfully meeting its primary endpoint.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion in support of the biosimilar prior to final EC approval.

“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, Alvotech.