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AVT04 is a monoclonal antibody biosimilar to ustekinumab (Stelara), developed by Alvotech. It binds to the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), which are involved in inflammatory and immune responses. By targeting the shared p40 subunit of IL-12 and IL-23, AVT04 prevents these cytokines from binding to their receptor complexes on natural killer cells and T cells, thereby inhibiting downstream pro-inflammatory signaling pathways associated with Th1 and Th17 cell lineages. AVT04 has demonstrated similar efficacy, safety, pharmacokinetics, and immunogenicity profiles compared to reference ustekinumab in clinical studies. It is approved for use in Japan (as Ustekinumab BS F), Canada (as Jamteki), and the European Economic Area (as Uzpruvo) for indications where Stelara is approved[1][4][5][6].
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