The U.S. Food and Drug Administration (FDA) has approved for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept), a biologic used to treat eye disorders, including those that can cause vision loss or blindness.

Eylea is a widely used biologic for the treatment of eye disorders, such as neovascular (wet) Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. The regulatory approval process is expected to be completed by 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 January 2024, Alvotech announced positive top-line results from a confirmatory clinical study (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence and comparable safety including immunogenicity between AVT06 and Eylea.

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