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Alvotech and Teva Earlier Announced Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara

Benzinga · 01/06/2023 06:12
Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech's proposed biosimilar to Stelara® (ustekinumab), which is prescribed to treat a variety of inflammatory conditions. The companies anticipate that the FDA's review will be completed in the second half of 2023.