European Commission Approves Alvotech's Mynzepli for Retinal Diseases

Alvotech SA, a biotechnology company, announced that the European Commission approved Mynzepli for the treatment of retinal diseases. The company's pipeline includes eight biosimilar candidates targeting various therapeutic areas, including autoimmune disorders, eye disorders, and cancer. Mynzepli is a biosimilar to Humira and has been approved for use in Europe.

The European Commission has approved Mynzepli, a biosimilar to Eylea® (aflibercept), for the treatment of various retinal diseases. Developed by Alvotech (NASDAQ: ALVO) and Advanz Pharma, Mynzepli is expected to provide significant market potential in the European market for retinal disease treatment.

Mynzepli received approval for multiple eye conditions including wet age-related macular degeneration (AMD), macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization. The approval covers all adult indications of the reference biologic and includes both pre-filled syringe and vial formulations, offering flexibility for healthcare providers.

The approval follows positive clinical trial results announced in January 2024, which demonstrated therapeutic equivalence to Eylea®. The European market for retinal disease treatment is valued at approximately $3 billion, with Eylea® generating about $9 billion in global sales in 2024, of which one-third came from Europe [1].

Alvotech's Chief Scientific and Technical Officer, Joseph McClellan, stated, "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."

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 Liechtenstein. Dossiers for Mynzepli are currently under review in other major markets, including the United States and Japan, indicating Alvotech's global ambitions.

Mynzepli is a recombinant fusion protein that binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. The approval of Mynzepli marks a significant milestone for Alvotech, which seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products.

References:
[1] https://www.stocktitan.net/news/ALVO/advanz-pharma-and-alvotech-receive-european-approval-for-mynzepli-0z9e8shlnh48.html
[2] Use of trademarks. Eylea® is a registered trademark of Bayer AG.