Alvotech, Advanz Pharma Secure EU Approval for Biosimilar Retinal Treatment

Alvotech SA, a biotechnology company, has received EU approval for its retinal treatment biosimilar. The company's pipeline includes eight biosimilar candidates for treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed strategic partnerships for global reach in markets such as the US, Europe, Japan, China, and other countries.

Alvotech SA, a biotechnology company, has secured European Union (EU) approval for its retinal treatment biosimilar, Mynzepli (aflibercept). This approval marks a significant milestone in Alvotech's strategy to develop and market biosimilar medicines globally. Mynzepli is a biosimilar to Eylea (aflibercept), which is used to treat various retinal diseases including neovascular age-related macular degeneration (AMD), macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization.

The approval covers all European Economic Area (EEA) countries, providing Alvotech with substantial market access. Eylea generated approximately $9 billion in global sales in 2024, with about $3 billion coming from Europe alone [1]. The approval of Mynzepli is expected to generate significant revenue potential in the $3 billion European market for retinal disease treatment.

Alvotech's Chief Scientific and Technical Officer, Joseph McClellan, commented on the approval, stating, "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 will be available in both pre-filled syringe and vial formulations, offering flexibility for healthcare providers. The approval follows positive clinical trial results that demonstrated therapeutic equivalence to Eylea. Alvotech's broader strategy includes concurrent regulatory reviews in other major markets, including the United States and Japan, which could further expand the company's market reach.

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