Positive top-line results have been announced from a confirmatory clinical study for AVT06, a biosimilar to Eylea (aflibercept) developed by the biotech Alvotech.
Eylea is a widely used biologic for the treatment of eye disorders, including diseases that can lead to vision loss or blindness, such as neovascular age-related macular degeneration (nAMD), macular oedema, and diabetic retinopathy.
The AVT06-GL-C01 confirmatory clinical study is a randomised, double-masked, parallel-group, multicentre, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in patients with nAMD. The primary outcome measure was change from baseline to week eight in best-corrected visual acuity (BCVA). The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea.
Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. The biotech has a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets including the United States, Europe, Japan, China and other Asian countries, large parts of South America, Africa, and the Middle East.
Robert Wessman, Chairman and CEO of Alvotech, said the progress of the company’s product pipeline “clearly illustrates the advantage” of an integrated development and manufacturing platform. Additionally, he said completing the key clinical milestone for AVT06 “demonstrates how our integrated approach enables the rapid advancement of multiple high-quality biosimilar candidates simultaneously”.
References
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
