Alvotech's AVT06 shows therapeutic equivalence to aflibercept in clinical trial

(image Credit: AdobeStock/kwanchaift)

Alvotech announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech’s proposed biosimilar to aflibercept.

In the new release¹, Robert Wessman, Chairman and CEO of Alvotech shared how the company’s focus on biosimilars propels it forward. He said, “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.”

Aflibercept, trademarked as Eylea by Regeneron Pharmaceuticals Inc, is used in the treatment of several eye disorders, including diseases known to cause vision loss or blindness, such as wet AMD, macular edema, and diabetic retinopathy.¹

The AVT06-GL-C01 confirmatory clinical study is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with aflibercept (Eylea) in patients with neovascular AMD. The primary outcome measure was change from baseline to Week 8 in Best-Corrected Visual Acuity (BCVA). The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea.¹

Founded with the sole focus of developing and manufacturing biosimilars medicines for patients worldwide, Alvotech’s strives to be a global leader in the biosimilar space by delivering high-quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities.¹

Reference:

1. Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea® (aflibercept). Alvotech. January 3, 2024. Accessed January 3, 2024. https://www.globenewswire.com/news-release/2024/01/03/2803065/0/en/Alvotech-Clinical-Study-Results-Demonstrate-Therapeutic-Equivalence-between-Biosimilar-Candidate-AVT06-and-Reference-Product-Eylea-aflibercept.html