Alvotech and Teva Announce Acceptance of BLA for AVT04, a Proposed Biosimilar to STELARA (ustekinumab)

On Jan 6, 2023, Alvotech and Teva announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab), and stated that the companies anticipate that the FDA’s review will be completed in the second half of 2023.

In August 2020, Alvotech and Teva announced a strategic partnership for the exclusive commercialization in the U.S. of five of Alvotech’s biosimilar product candidates. Then in May 2022, Alvotech announced that a confirmatory clinical, safety and efficacy study for AVT04 had met its primary endpoint, demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and the reference product in patients with moderate to severe chronic plaque-type psoriasis. Also in May 2022, Alvotech announced positive results from a pharmacokinetic similarity study for AVT04.