New report: Alvotech announces positive top-line results for AVT06, a proposed biosimilar to aflibercept

Alvotech announced clinical study results demonstrating therapeutic equivalence for its proposed biosimilar, AVT06. Image credit: ©Nuttapong punna – stock.adobe.com

Alvotech announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech’s proposed biosimilar to aflibercept. Alvotech is headquartered in Reykjavík, Iceland, with offices in India, the United States and throughout Europe.

In the news 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 as wet AMD, macular oedema 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 strives to be a global leader in the biosimilar space. According to company materials, Alvotech focuses on 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