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FDA Accepts Alvotech And Teva's Biosimilar AVT05 For BLA Review

Alvotech and Teva’s biosimilar for Simponi® earns FDA acceptance; decision expected by Q4 2025.

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  • Jan 28, 2025

  • Simantini Singh Deo

FDA Accepts Alvotech And Teva's Biosimilar AVT05 For BLA Review

Alvotech, a global biotech company focused on biosimilar medicines, and Teva Pharmaceuticals, the U.S. arm of Teva Pharmaceutical Industries announced that the FDA has accepted Biologics License Applications (BLA) for AVT05, Alvotech’s biosimilar to Simponi® and Simponi Aria® (golimumab). These medications are used to treat inflammatory conditions. This marks the first time the FDA has accepted a biosimilar candidate for golimumab, with a decision expected by the fourth quarter of 2025. Alvotech had previously reported positive clinical results for AVT05. 

Joseph McClellan, Chief Scientific Officer of Alvotech, said in a statement, "This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab. Our in-house capability, which allows 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."

In April 2024, a confirmatory study showed comparable efficacy, safety, and immunogenicity to Simponi® in rheumatoid arthritis patients. Additionally, in November 2023, a pharmacokinetic study demonstrated that AVT05 had similar safety, tolerability, and drug absorption in healthy participants. Alvotech and Teva have been strategic partners since 2020, working together to develop and commercialize biosimilar products. Alvotech leads the development and manufacturing, while Teva handles U.S. commercialization by utilising its strong sales and marketing capabilities. Initially focusing on five products, the partnership has since expanded to include nine.

Thomas Rainey, Senior Vice President of U.S. Biosimilars at Teva, commented, “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.”

The collaboration has already resulted in two FDA-approved biosimilars. In February 2024, SIMLANDI® (adalimumab-ryvk), a high-concentration interchangeable biosimilar to Humira®, received FDA approval and was launched in May 2024. SELARSDITM (ustekinumab-aekn), a biosimilar to Stelara®, was approved in April 2024 and is set to enter the U.S. market in February 2025.

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