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Alvotech and Advanz Pharma announced on June 23, 2025, that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for AVT06, a proposed biosimilar to Eylea® (aflibercept 2 mg). This positive recommendation may lead to the marketing authorization of AVT06 in the European Economic Area, addressing significant medical needs for treating eye disorders like neovascular age-related macular degeneration and diabetic macular edema.
The global sales of Eylea® reached approximately US$9 billion in 2024, with a significant portion of these sales occurring in Europe. Alvotech oversees the development and commercial supply of AVT06, while Advanz Pharma handles registration and has exclusive commercialization rights across most European markets.
Despite the positive opinion, there is no specific timeline for the market launch of AVT06, and it remains classified as an investigational product pending regulatory approval in any country.
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