Mynzepli approved in all European Economic Area member countries for retinal diseases.

Alvotech and Advanz Pharma announce the European Commission's approval of Mynzepli (aflibercept) as a biosimilar to Eylea (aflibercept) for the treatment of various retinal diseases, including neovascular age-related macular degeneration. Approval is based on comprehensive analytical, non-clinical and clinical similarity data, including a confirmatory efficacy study. Mynzepli will be available in pre-filled syringe and vial formulations.

Alvotech (NASDAQ: ALVO) and Advanz Pharma have received significant news with the European Commission's approval of Mynzepli (aflibercept) as a biosimilar to Eylea (aflibercept). This approval marks a pivotal moment for both companies, granting them access to a substantial market for treating various retinal diseases.

Mynzepli is approved for treating multiple eye conditions, including wet age-related macular degeneration (AMD), macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization. The approval covers all European Economic Area countries, providing significant revenue potential in a $3 billion European market for retinal disease treatment [1].

The approval follows positive clinical trial results that demonstrated therapeutic equivalence to Eylea. The biosimilar will be available in both pre-filled syringe and vial formats, offering flexibility for healthcare providers. This comprehensive approval scope maximizes Mynzepli's potential market reach.

Alvotech's Chief Scientific and Technical Officer, Joseph McClellan, commented, "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." Nick Warwick, Chief Medical Officer of Advanz Pharma, added, "The approval of Mynzepli marks an important milestone in our mission to broaden access to high-quality and affordable medicines for patients across Europe."

Mynzepli's approval is part of Alvotech's broader strategy to develop and market biosimilar medicines globally. The company's global ambitions are evident with concurrent regulatory reviews underway in other major markets, including the United States and Japan. If approved in these regions, Alvotech would gain access to even larger portions of the global Eylea market.

The approval of Mynzepli comes at a time when healthcare systems worldwide are seeking cost-effective alternatives to expensive biologics. Biosimilars typically launch at 15-30% discounts to reference products, which could translate to substantial savings for European healthcare systems while maintaining revenue growth opportunities for Alvotech.

References:
[1] https://www.stocktitan.net/news/ALVO/advanz-pharma-and-alvotech-receive-european-approval-for-mynzepli-0z9e8shlnh48.html