Drug intelligence / Profile preview

ustekinumab CT-P43

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

Overview

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.

Brand names
STEQEYMA
Other names
ustekinumab-stba
02

Targets

IL12B (Interleukin-12/23 p40 subunit)

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