Alvotech (ALVO) and Teva Pharmaceuticals, a subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA) based in the U.S., have announced that the FDA has accepted Biologics License Applications for AVT05 for review. AVT05 is Alvotech's proposed biosimilar to Simponi and Simponi Aria, known generically as golimumab, which are used to treat various inflammatory conditions. Importantly, these applications represent the first instance of a biosimilar candidate to golimumab being accepted for filing in the U.S. The FDA's review process is projected to conclude in the fourth quarter of 2025.
Back in 2020, Alvotech and Teva established a strategic alliance focused on the exclusive commercialization of five biosimilar product candidates from Alvotech, including AVT05. Since this partnership was formed, two biosimilars developed under this collaboration have successfully obtained FDA approval.
