In July 2025, Alvotech and Teva jointly announced that the FDA accepted their Biologics License Application (BLA) for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab). The submission includes data from analytical, non-clinical, and Phase I/III clinical studies that demonstrated biosimilarity in pharmacokinetics, efficacy, and safety. AVT05 is expected to be reviewed under the Biosimilar User Fee Act (BsUFA) with a decision projected in mid-2026. If approved, it would become the first biosimilar to Simponi Aria in the U.S., potentially offering cost savings and market pressure on the IV golimumab franchise. Simponi Aria's utilization has been stable but lags behind subcutaneous TNF options in PsA. With biosimilars gaining traction in rheumatology and gastroenterology, this development may signal a shift in payer preference toward lower-cost alternatives.

Citation: https://www.alvotech.com/news/alvotech-and-teva-announce-fda-acceptance-of-bla-for-avt05-biosimilar-to-simponi-and-simponi-aria/

Implication: AVT05's entry could reduce Simponi Aria's market share, especially if payer-mandated switching occurs.