Alvotech and Teva Pharmaceuticals announce FDA accepts Biologics License Application for AVT06

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Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept) 2 mg.

Joseph McClellan, chief scientific officer of Alvotech, and Thomas Rainey, senior vice president, US biosimilars at Teva, commented on the acceptance in a press release from the company.

"Our success in developing multiple biosimilar candidates in parallel for global markets demonstrates the advantage of our fully integrated approach and broad in-house capabilities in both R&D and manufacturing," said McClellan. While Rainey stated, "This acceptance continues to build on our shared commitment to improving patient outcomes by offering cost-saving and accessible options."

Alvotech is also currently developing AVT29, a biosimilar candidate for Eylea HD (aflibercept) 8 mg.

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) age-related macular degeneration (AMD).

According to the companies, the process to obtain regulatory approval is anticipated to be completed in the fourth quarter of 2025.

Reference:

1. Alvotech and Teva announce filing acceptance of U.S. biologics license application for AVT06, a proposed biosimilar to Eylea (aflibercept). Published February 18, 2025. Accessed February 18, 2025.https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-teva-announce-filing-acceptance-us-biologics-0