EMA Recommends Approval of Alvotech's Biosimilar to Eylea for Eye Disorders
核心洞察
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval for AVT06, Alvotech's proposed biosimilar to Eylea (aflibercept 2 mg).
The biosimilar is intended for treating adults with neovascular age-related macular degeneration (搜索), visual impairment due to macular edema (搜索) secondary to retinal vein occlusion (搜索), diabetic macular edema (搜索), and myopic choroidal neovascularization (搜索).
Alvotech's confirmatory clinical study demonstrated therapeutic equivalence between AVT06 and Eylea in patients with neovascular AMD, meeting the primary endpoint.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval for AVT06, Alvotech's proposed biosimilar to Eylea (aflibercept 2 mg), marking a significant milestone in expanding access to treatments for serious eye disorders across Europe.
The positive recommendation from CHMP enables the European Commission to approve the biosimilar for marketing throughout the European Economic Area, which encompasses the 27 European Union member states plus Norway, Iceland, and Liechtenstein.
Therapeutic Indications and Market Impact
The CHMP opinion recommends granting marketing authorization for AVT06 for treating adults with several vision-threatening conditions: neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema (搜索) secondary to retinal vein occlusion (搜索) (branch RVO or central RVO), visual impairment due to diabetic macular edema (搜索) (DME), and visual impairment due to myopic choroidal neovascularization (搜索) (myopic CNV).
The market opportunity is substantial, with global sales of Eylea reaching approximately $9 billion in 2024, and one-third of these sales occurring in Europe. This biosimilar entry could significantly impact treatment accessibility and healthcare costs across the region.
Clinical Evidence Supporting Approval
Alvotech's regulatory submission was supported by positive results from a confirmatory clinical study (AVT06-GL-C01) announced in January 2024. The randomized, double-masked, parallel-group, multicenter study compared the efficacy, safety, and immunogenicity of AVT06 to Eylea in patients with neovascular AMD.
The study successfully met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech's biosimilar candidate and the reference product Eylea. This clinical evidence formed the foundation for the regulatory approval recommendation.
Mechanism of Action and Development
AVT06 is a recombinant fusion protein that functions as a biosimilar candidate to Eylea (aflibercept). The drug works by binding vascular endothelial growth factors (搜索) (VEGF (搜索)), thereby inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability.
Beyond AVT06, Alvotech is also developing AVT29, a proposed biosimilar to Eylea HD, which contains a higher dose of aflibercept (8 mg). Advanz Pharma (搜索) has licensed distribution rights from Alvotech for both biosimilar candidates within the same territory.
Partnership and Commercialization Strategy
The collaboration between Alvotech and Advanz Pharma (搜索) divides responsibilities strategically: Alvotech handles development and commercial supply of the proposed biosimilar, while Advanz Pharma manages registration and holds exclusive commercialization rights for most European countries.
"CHMP's positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers. Alvotech looks forward to increasing access to this vital biologic treatment for eye disorders," said Joseph McClellan, Chief Scientific Officer of Alvotech.
Nick Warwick, Chief Medical Officer of Advanz Pharma (搜索), added, "We are pleased with the CHMP's positive opinion, which marks an important milestone in our mission to bring high-quality, specialist medicines to patients across Europe."
The positive CHMP opinion represents a crucial step toward final European Commission approval, which would enable the biosimilar's commercial launch across the European Economic Area, potentially improving treatment accessibility for patients with serious retinal disorders while offering healthcare systems a cost-effective alternative to the reference product.