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FDA accepts Alvotech, Teva's BLA for proposed Eylea biosimilar

Eylea is a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness.

Alvotech and Teva shared that the Food and Drug Administration has accepted for review a Biologics License Application for AVT06, Alvotech’s proposed biosimilar to Regeneron’s Eylea (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness.

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

"We are extremely pleased with this new step in the development of our biosimilar candidate to Eylea, as better access will benefit patients and their caregivers," said Joseph McClellan, chief scientific officer of Alvotech. "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."

“We are delighted to share this latest biosimilar milestone with Alvotech for those living with retinal diseases,” said Thomas Rainey, senior vice president, U.S. biosimilars at Teva. “This acceptance continues to build on our shared commitment to improving patient outcomes by offering cost saving and accessible options.”

In addition to AVT06, which is a biosimilar candidate for Eylea 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea HD 8 mg. Teva also holds commercialization rights for AVT29 in the United States.

Eylea is a widely used biologic for the treatment of eye disorders, such as neovascular (wet) age-related macular degeneration, macular edema and diabetic retinopathy. In 2024, sales of Eylea (low dose and HD combined) were $4.77 billion, Teva said.

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