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Drug intelligence / Profile preview
ustekinumab CT-P43 is a biosimilar monoclonal antibody developed as an alternative to originator ustekinumab (Stelara). It is a fully human monoclonal antibody that targets the p40 subunit shared by **interleukin-12 (IL-12)** and **interleukin-23 (IL-23)**, antagonizing these cytokines to inhibit inflammatory signaling. Its therapeutic effects derive from blocking these cytokine pathways involved in immune-mediated diseases. ustekinumab CT-P43, branded as STEQEYMA, is FDA-approved for adults and children with **plaque psoriasis** and **psoriatic arthritis**, and for adults with **Crohn's disease** and **ulcerative colitis**, matching the indications of its reference biologic. The biosimilar exhibits equivalent efficacy, pharmacokinetics, safety, and immunogenicity compared to originator ustekinumab, as demonstrated in phase III trials in moderate to severe plaque psoriasis.
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