FDA Accepts BLA for AVT06 Biosimilar to Eylea

Alvotech and Teva Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for AVT06, a proposed biosimilar to Eylea (aflibercept) 2 mg. This milestone marks a significant step in expanding treatment options for patients with retinal diseases.

Industry Leaders Highlight the Impact of AVT06

Key executives from both companies emphasized the importance of this development in a recent press release.

“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 Joseph McClellan, Chief Scientific Officer at Alvotech.

“This acceptance continues to build on our shared commitment to improving patient outcomes by offering cost-saving and accessible options,” stated Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva.

AVT06: A Step Toward Expanding Biosimilar Options in Ophthalmology

AVT06 is designed as a biosimilar to Eylea (aflibercept) 2 mg, a widely used anti-VEGF therapy for the treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal diseases. The acceptance of the BLA submission moves AVT06 one step closer to regulatory approval in the United States.

Ongoing Developments: AVT29 and Eylea HD Biosimilars

In addition to AVT06, Alvotech is developing AVT29, a biosimilar candidate for Eylea HD (aflibercept) 8 mg, further strengthening its pipeline of ophthalmic biosimilars.

Clinical Progress and Regulatory Timeline

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study, which assessed the efficacy, safety, and immunogenicity of AVT06 compared to Eylea in patients with wet AMD.

The regulatory review process is expected to be completed by Q4 2025, potentially bringing a more affordable biosimilar treatment option to retinal disease patients in the U.S.

With this development, Alvotech and Teva continue to drive innovation in the ophthalmology space, aiming to enhance accessibility to high-quality biosimilars while maintaining clinical efficacy and safety standards.