Alvotech's Biosimilar AVT06 Shows Promise in Eylea Equivalence Study
Alvotech announced positive top-line results from a crucial confirmatory clinical study for AVT06, its proposed biosimilar to Eylea® (aflibercept), a widely used biologic for treating eye disorders.
Robert Wessman, Chairman and CEO of Alvotech, highlighted the significance of the achievement, stating, "The progress of our product pipeline clearly illustrates the advantage of our integrated development and manufacturing platform, which allows Alvotech to pursue its diversified global biosimilar strategy. Completing this key clinical milestone for AVT06 also demonstrates how our integrated approach enables the rapid advancement of multiple high-quality biosimilar candidates simultaneously."
Eylea, addressing eye disorders leading to vision impairment or blindness such as wet AMD, macular edema, and diabetic retinopathy, has accumulated global sales of approximately US$9.4 billion in the twelve months leading up to September 30, 2023.
The AVT06-GL-C01 confirmatory clinical study, a randomized, double-masked, parallel-group, multicenter therapeutic equivalence study, focused on evaluating the efficacy, safety, and immunogenicity of AVT06 in comparison to Eylea specifically in patients with neovascular (wet) AMD. The primary outcome measure, the change from baseline to Week 8 in Best-Corrected Visual Acuity (BCVA), was successfully met. Results indicate therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea.
About AVT06, a recombinant fusion protein and a biosimilar candidate to Eylea, it functions by binding vascular endothelial growth factors (VEGF), inhibiting neovascularization, and reducing vascular permeability. AVT06 remains an investigational product, with no regulatory approval in any country, and biosimilarity has not yet been established or claimed by regulatory authorities.
