Drug intelligence / Profile preview

AVT04

Development stage
Approved
Lead developer
Alvotech
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous, Intravenous
01

Overview

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].

Brand names
JamtekiUzpruvoUstekinumab BS F
Other names
ustekinumab biosimilar
02

Targets

IL12B (Interleukin-12/23 p40 subunit)

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