- The FDA has accepted Alvotech and Teva Pharmaceuticals’ Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to Simponi (golimumab).
- The FDA decision is expected in Q4 2025, potentially marking the first biosimilar golimumab approved in the U.S.

Alvotech, a global biotech company focused on biosimilars, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has accepted their Biologics License Applications (BLAs) for AVT05. The proposed biosimilar targets Simponi and Simponi Aria (golimumab), which are used to treat inflammatory conditions. This milestone represents the first U.S. BLA acceptance for a biosimilar to golimumab, with an FDA decision expected in the fourth quarter of 2025.
“This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “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.”
Alvotech and Teva began their strategic partnership in 2020, focusing on the development and commercialization of biosimilars. Teva is responsible for U.S. sales, while Alvotech oversees development and manufacturing using its end-to-end platform. The partnership has expanded to include nine biosimilar candidates.
The FDA’s acceptance follows positive clinical trial results. In April 2024, Alvotech reported strong efficacy, safety, and immunogenicity outcomes for AVT05 in rheumatoid arthritis patients. Earlier studies also confirmed pharmacokinetic and safety equivalence to Simponi in healthy participants.
Teva’s Senior Vice President of U.S. Biosimilars, Thomas Rainey, noted, “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 bring cost-saving options to more patients and deliver better outcomes for those with inflammatory conditions.”
Alvotech and Teva have previously secured FDA approval for two biosimilars, SIMLANDI (adalimumab-ryvk) and SELARSDITM (ustekinumab-aekn), further demonstrating their capabilities in the biosimilars market.