The FDA has accepted the Biologics License Application (BLA) for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab), developed by Alvotech and Teva Pharmaceuticals. This marks the first BLA filing acceptance in the U.S. for a biosimilar candidate to golimumab, a TNF-alpha inhibitor used to treat various inflammatory conditions. The FDA review process is anticipated to conclude in the fourth quarter of 2025, potentially bringing a more affordable treatment option to patients suffering from rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
Clinical Data Supporting AVT05
Alvotech announced positive top-line results from a confirmatory clinical study in April 2024, which compared the efficacy, safety, and immunogenicity of AVT05 to Simponi in patients with moderate to severe rheumatoid arthritis. The study met its primary endpoint, demonstrating therapeutic comparability between the biosimilar and the reference product.
Previously, in November 2023, Alvotech reported positive results from a pharmacokinetic study assessing the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult participants. These studies provide a robust foundation for the FDA's review of AVT05.
Strategic Partnership and Biosimilar Pipeline
Alvotech and Teva entered into a strategic partnership in August 2020 for the commercialization of several Alvotech biosimilar candidates, including AVT05. Alvotech is responsible for development and manufacturing, while Teva handles commercialization in the U.S. This collaboration has already led to the FDA approval of two biosimilars: SIMLANDI (adalimumab-ryvk), a biosimilar to Humira, and SELARSDI (ustekinumab-aekn), a biosimilar to Stelara.
Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, stated, "Biosimilars are ushering a new treatment paradigm and have become an integral staple in the healthcare ecosystem. Teva’s strategic partnership with Alvotech underscores our commitment to continue to bring cost-saving options to more patients and deliver better outcomes for those with inflammatory conditions."
About Golimumab and AVT05
Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF-alpha), a key cytokine involved in inflammatory processes. Elevated TNF-alpha levels are implicated in the pathophysiology of several chronic inflammatory diseases. Simponi and Simponi Aria, the reference products, are approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Joseph McClellan, Chief Scientific Officer of Alvotech, commented, "This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab. 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."
