FDA accepts Alvotech, Teva's BLAs for Simponi biosimilars

Simponi and Simponi Aria (golimumab) are prescribed to treat a variety of inflammatory conditions.

2/4/2025

Alvotech and Teva announced that the Food and Drug Administration has accepted for review Biologics License Applications for AVT05, Alvotech’s proposed biosimilar to Simponi and Simponi Aria (golimumab), which are prescribed to treat a variety of inflammatory conditions.

These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed 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."

Thomas Rainey, senior vice president, U.S. biosimilars at Teva, added, “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.”