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

News
Article

The study illustrates efficacy of AVT06 as compared with aflibercept (Eylea) for neovascular age-related macular degeneration

A group of people at a table look at data from study results. Image credit: ©Nuttapong punna – stock.adobe.com

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
Recent Videos
Charles Wykoff, MD, PhD, discusses his Floretina ICOOR presentation topic, retinal non-perfusion in diabetic retinopathy, with David Hutton, editor of Ophthalmology Times
Quan Dong Nguyen, MD, MSc, of the Byers Eye Institute at Stanford University School of Medicine, discusses his presentation on Stargardt disease at the American Academy of Ophthalmology meeting
David Yorston, FRCS, FRCOphth, discusses his EURETINA keynote lecture
Hoda Shamsnajafabadi, MSc, PhD, presents at the 2024 EURETINA meeting
Timothy L Jackson PhD, MB ChB, FRCOphth, speaks about a combination therapy for VEGF-A/C/D inhibition with sozinibercept and ranibizumab
Carl Awh, MD, FASRS, speaks about the American Society of Retina Specialists (ASRS) at EURETINA
Stefano Mercuri, MD, first author of the winning eposter “Genotype-phenotype correlations in a cohort of genetically determined Retinitis Pigmentosa (RP) Italian patients with Rho gene mutations”
Bahram Bodaghi, MD, PHD, FEBO at the 2024 EURETINA meeting
Aleksandra Rachitskaya, MD, FASRS, speaks about the Vit-Buckle Society at the 2024 EURETINA Congress.
© 2024 MJH Life Sciences

All rights reserved.