Alvotech and Teva Pharmaceuticals have announced that the US Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for AVT06.
AVT06 is a proposed biosimilar to Eylea (aflibercept), a treatment for eye disorders that can cause vision loss or blindness.
The FDA will review the application, with regulatory approval expected by Q4 2025.
Alvotech is developing two biosimilars for Eylea. AVT06 targets the 2 mg dose, while AVT29 is an investigational biosimilar candidate for the 8 mg HD dose.
Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries, also holds the commercialisation rights for AVT29 in the US.
Eylea is used to treat eye disorders like neovascular (wet) Age-related Macular Degeneration (AMD), macular oedema, and diabetic retinopathy.
In 2024, aflibercept sales in the US reached $4.77bn.
Alvotech chief scientific officer Joseph McClellan said: “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.
“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.”
In January last year, Alvotech announced positive top-line results from the AVT06-GL-C01 confirmatory clinical study.
The study compared the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) AMD.
The results met the primary endpoint, showing therapeutic equivalence and comparable safety, including immunogenicity, between AVT06 and aflibercept.
Teva Biosimilars US senior vice president Thomas Rainey said: “We are delighted to share this latest biosimilar milestone with Alvotech for those living with retinal diseases.
“This acceptance continues to build on our shared commitment to improving patient outcomes by offering cost saving and accessible options.”
Nasdaq-listed Alvotech global biotech company specialising in developing biosimilar medicines.
Last month, Alvotech and Teva Pharmaceuticals announced that the FDA has accepted the BLA for AVT05, a biosimilar to Simponi and Simponi Aria (golimumab). These drugs treat various inflammatory conditions.
The FDA review process is expected to be completed by Q4 2025.
In November 2024, Sandoz secured the European Commission (EC) approval for Eylea biosimilar, Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection.
