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ustekinumab-aauz
- Development stage
- Approved
- Lead developer
- Formycon
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous, Subcutaneous
01
Overview
FYB202 (ustekinumab-aauz) is a biosimilar to the reference drug Stelara (ustekinumab), developed by Formycon and Fresenius Kabi. It is a recombinant human monoclonal antibody of the IgG1 kappa subclass that targets the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23), thereby inhibiting their activity. This mechanism suppresses pro-inflammatory signaling pathways involved in several serious inflammatory diseases. FYB202 is indicated for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The drug has demonstrated pharmacokinetic equivalence and comparable efficacy and safety to reference ustekinumab in clinical trials. It received regulatory approvals in the US, EU, UK, and Canada between September 2024 and early 2025[1][2][3][4][5].
- Brand names
- Otulfi
- Other names
- ustekinumab-aauzustekinumab biosimilarStelara biosimilar candidate
02
Targets
IL12B (Interleukin-12/23 p40 subunit)IL12RB1 (Interleukin-12 receptor)
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