06.01.2023 13:50:44

Alvotech : FDA Accepts BLA For AVT04, Proposed Biosimilar To Stelara

(RTTNews) - Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), said that the U.S. Food and Drug Administration has accepted for review a Biologics License Application 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 second half of 2023.

AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. AVT04 is an investigational product and has not received regulatory approval in any country.

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