Drug intelligence / Profile preview

ustekinumab biosimilar ABP 654

Development stage
Phase 3
Lead developer
Amgen
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Subcutaneous
01

Overview

ABP 654 is a biosimilar to ustekinumab, a recombinant human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that acts as an antagonist of interleukin-12 (IL-12) and interleukin-23 (IL-23). It binds with high specificity and affinity to the p40 protein subunit shared by both IL-12 and IL-23 cytokines, thereby inhibiting their signaling pathways. This mechanism disrupts inflammatory cascades involved in chronic immune-mediated diseases. ABP 654 is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients, active psoriatic arthritis in adults and pediatric patients, moderate-to-severe active Crohn’s disease in adults, and moderate-to-severe active ulcerative colitis in adults. Developed by Amgen, ABP 654 is the first FDA-approved interchangeable biosimilar for ustekinumab[1][2][3][4][5][6].

Brand names
WEZLANAWEZENLA
Other names
ustekinumab-auub
02

Targets

IL-23 (Interleukin-23)

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