Alvotech's Biosimilar Candidate AVT06 Demonstrates Therapeutic Equivalence to Eylea
Alvotech announced positive results from a confirmatory clinical study for AVT06, its proposed biosimilar to Eylea. The study met its primary endpoint, showing therapeutic equivalence between the candidate and the reference product.
Icelandic biotechnology company Alvotech has announced positive top-line results from a confirmatory clinical study for AVT06, its proposed biosimilar to Eylea® (aflibercept). The drug is a treatment commonly used for various eye conditions.
The study evaluated the efficacy, safety, and immunogenicity of AVT06 compared to Eylea in patients diagnosed with neovascular (wet) age-related macular degeneration (AMD). The primary endpoint, best-corrected visual acuity (BCVA) change from baseline at Week 8, was met, demonstrating therapeutic equivalence.
Eylea, which generated approximately $9.4 billion in global sales in the twelve months prior to September 30, 2023, is a significant treatment for vision-threatening conditions including wet AMD, macular edema, and diabetic retinopathy. AVT06's successful clinical trial is a key step for Alvotech in expanding its biosimilar offerings.
Alvotech specializes in the development and manufacturing of biosimilar medicines worldwide. The company states that its integrated development and manufacturing platform allows for the rapid advancement of multiple high-quality biosimilar candidates simultaneously. AVT06 is an investigational product and has not yet received regulatory approval in any country.