Alvotech, Teva announce FDA accepts BLA for AVT05

Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the U.S. FDA has accepted for review Biologics License Applications for AVT05, Alvotech’s proposed biosimilar to Simponi and Simponi Aria, 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.