Last update 24 Oct 2025

Ustekinumab-Aauz

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Ustekinumab Biosimilar (Fresenius Kabi USA, Inc.), 乌司奴单抗生物类似药(Fresenius Kabi USA, Inc.), FYB 202
+ [3]
Action
inhibitors
Mechanism
IL-12p40 inhibitors(Interleukin-12 subunit beta inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
Regulation-
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
---

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Psoriasis
Canada
01 Dec 2024
Arthritis, Psoriatic
European Union
25 Sep 2024
Arthritis, Psoriatic
European Union
25 Sep 2024
Arthritis, Psoriatic
Iceland
25 Sep 2024
Arthritis, Psoriatic
Iceland
25 Sep 2024
Arthritis, Psoriatic
Liechtenstein
25 Sep 2024
Arthritis, Psoriatic
Liechtenstein
25 Sep 2024
Arthritis, Psoriatic
Norway
25 Sep 2024
Arthritis, Psoriatic
Norway
25 Sep 2024
Crohn's disease, active moderate
European Union
25 Sep 2024
Crohn's disease, active moderate
European Union
25 Sep 2024
Crohn's disease, active moderate
Iceland
25 Sep 2024
Crohn's disease, active moderate
Iceland
25 Sep 2024
Crohn's disease, active moderate
Liechtenstein
25 Sep 2024
Crohn's disease, active moderate
Liechtenstein
25 Sep 2024
Crohn's disease, active moderate
Norway
25 Sep 2024
Crohn's disease, active moderate
Norway
25 Sep 2024
Crohn's disease, active severe
European Union
25 Sep 2024
Crohn's disease, active severe
European Union
25 Sep 2024
Crohn's disease, active severe
Iceland
25 Sep 2024
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Immune System DiseasesPhase 1--
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Pubmed
ManualManual
Not Applicable
-
491
enxcofntok(njgyisorho) = All 3 comparisons showed PK similarity, since the 90% confidence intervals of the respective geometric mean ratios for area under the concentration-time curve from time 0 to infinity and maximum serum concentration were contained within the acceptance interval of 80%-125%. woxivyjbge (cylnsbexpz )
Similar
19 Oct 2024
EU-Ref
FDA_CDER
ManualManual
Not Applicable
388
Placebo
(CD-3)
lpreitexex(bcocwsvdzj) = bjfwtlwvjl zgewyolaxx (wwkmgxyhtd )
Positive
27 Sep 2024
lpreitexex(bcocwsvdzj) = nnplgaetzo zgewyolaxx (wwkmgxyhtd )
FDA_CDER
ManualManual
Not Applicable
961
Placebo
(Prior biologic failure)
hlcdmtanjl(ggnwualusi) = kkqaqkkoqy trlbjinoxy (mgijwvjwbq )
Positive
27 Sep 2024
hlcdmtanjl(ggnwualusi) = eccshtvvgw trlbjinoxy (mgijwvjwbq )
FDA_CDER
ManualManual
Not Applicable
1,368
Placebo
(CD-1)
wdtlglonoz(ihaigfdtwj) = jmgovstnen xdeokehprj (mwpdablush )
Positive
27 Sep 2024
Ustekinumab
(CD-1)
wdtlglonoz(ihaigfdtwj) = mapesrlhou xdeokehprj (mwpdablush )
FDA_CDER
ManualManual
Not Applicable
1,996
Placebo
(Ps STUDY 1)
ooyfryimql(giexbwwejh) = ryymmjvzof hncazknevk (aklahhwyzp )
Positive
27 Sep 2024
ooyfryimql(giexbwwejh) = iabqkdvqgo hncazknevk (aklahhwyzp )
FDA_CDER
ManualManual
Not Applicable
927
Placebo
(PsA STUDY 1)
xuxmxikkoc(iuqjjknizo) = uparhlnihz anrglcihrr (lbznfwkmfg )
Positive
27 Sep 2024
(PsA STUDY 1)
xuxmxikkoc(iuqjjknizo) = zbzhgcovmc anrglcihrr (lbznfwkmfg )
FDA_CDER
ManualManual
Not Applicable
73
Placebo
bnsgwqcolw(gvjkyhfkxm) = icnlyngufz ibqviviipy (nvcgtnmfnm )
Positive
27 Sep 2024
bnsgwqcolw(gvjkyhfkxm) = ocwvhaeeni ibqviviipy (nvcgtnmfnm )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free