Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US
Shots:
- The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25
- AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization, and vascular permeability. Teva holds US commercialization rights for AVT29
- On Jan’24, Alvotech reported the positive top-line data from its trial (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) AMD. Furthermore, the company is also developing a biosimilar of Eylea i.e. AVT29 (8mg)
Ref: Alvotech | Image: Alvotech & Teva
Related News:- Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)
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