Aflibercept Biosimilar AVT06 up for Review for Inherited Retinal Diseases

The FDA has accepted Alvotech and Teva’s Biologics License Application (BLA) for AVT06, a proposed biosimilar for aflibercept (Eylea) to treat inherited retinal diseases (IRDs), Teva announced today. The review is expected to complete by the fourth quarter of 2025.¹

"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," Joseph McClellan, Chief Scientific Officer of Alvotech, said in a statement.¹ "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."

AVT06 is intended to treat the IRDs that aflibercept is indicated for, including neovascular (wet) Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. It is a recombinant fusion protein that inhibits the binding and activation of VEGF receptors, neovascularization, and vascular permeability.

“We are delighted to share this latest biosimilar milestone with Alvotech for those living with retinal diseases,” Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, added.¹ “This acceptance continues to build on our shared commitment to improving patient outcomes by offering cost saving and accessible options.”

Alovtech previously announced topline results from the confirmatory clinical AVT06-GL-C01 study that demonstrated therapeutic equivalence and comparable immunogenicity and safety between AVT06 and aflibercept in patients with wet AMD, meeting the study’s primary endpoint.²

The AVT06-GL-C01 confirmatory clinical study is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study with a primary outcome measure of change from baseline to Week 8 in Best-Corrected Visual Acuity (BCVA).

“The progress of our product pipeline clearly illustrates the advantage of our integrated development and manufacturing platform, which allows Alvotech to pursue its diversified global biosimilar strategy,” Robert Wessman, Chairman and CEO of Alvotech, said in a statement at that time.² “Completing this key clinical milestone for AVT06, also demonstrates how our integrated approach enables the rapid advancement of multiple high-quality biosimilar candidates simultaneously.”

It's been a good month for the 2 companies, with the FDA accepting another BLA for their golimumab (Simponi) biosimilar AVT05 for treating inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and ulcerative colitis (UC).³

AVT05’s review is also expected to be completed in the fourth quarter of 2025. These submissions were based off of positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between AVT05 and reference golimumab in patients with moderate to severe rheumatoid arthritis. Another previous pharmacokinetic study demonstrated comparable pharmacokinetics, safety, and tolerability of AVT05 compared to and reference golimumab in healthy adult participants, data from which was announced in November 2023.³

"This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab," McClellan said earlier in February.³ “Our in-house capability allowing us to match the cell line and process used to manufacture the reference biologic, has given us an important head start in developing a biosimilar candidate to Simponi® and Simponi Aria® for global markets."

REFERENCES
1. Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept). News release. Teva. February 18, 2025. https://www.tevapharm.com/news-and-media/latest-news/alvotech-and-teva-announce-filing-acceptance-ofu.s.-biologics-license-application-for-avt06a-proposed-

2. Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea® (aflibercept). News release. January 3, 2024. Alvotech. https://investors.alvotech.com/news-releases/news-release-details/alvotech-clinical-study-results-demonstrate-therapeutic-0

3. Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab). News release. Alvotech. January 27, 2025. https://www.globenewswire.com/news-release/2025/01/27/3015410/0/en/Alvotech-and-Teva-Announce-Filing-Acceptance-of-U-S-Biologics-License-Applications-for-AVT05-a-Proposed-Biosimilar-to-Simponi-and-Simponi-Aria-golimumab.html