Last update 29 Jul 2026

Ustekinumab-kfce

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Ustekinumab (BIOSIMILAR COLLABORATIONS IRELAND LIMITED), Ustekinumab Biosimilar (Biocon Ltd.), 乌司奴单抗生物类似药(Biocon Ltd.)
+ [3]
Target
Action
inhibitors
Mechanism
IL-12p40 inhibitors(Interleukin-12 subunit beta inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Colitis, Ulcerative
Canada
17 Oct 2025
Arthritis, Psoriatic
United States
29 Nov 2024
Crohn's disease, active moderate
United States
29 Nov 2024
Crohn's disease, active severe
United States
29 Nov 2024
Plaque psoriasis
United States
29 Nov 2024
Ulcerative colitis, active moderate
United States
29 Nov 2024
Ulcerative colitis, active severe
United States
29 Nov 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseasePhase 1
United Kingdom
19 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
324
wnzarqxiiy(xfjmxgvlcl) = hunnefwhpx nakavxvpkc (rgtvnibjij, 7.51)
Positive
21 Oct 2025
wnzarqxiiy(xfjmxgvlcl) = dfsdhtuigc nakavxvpkc (rgtvnibjij, 5.67)
Phase 3
384
oqzlqteuul(hkaeujmoic): Difference (%) = 0.68 (90.0% CI, -1.27 to 2.63)
Positive
03 Aug 2025
Phase 3
384
jwovnhwdlc(vjspmjgjwt) = uthzwjoghz igouilccnb (inkffiwzkm )
Positive
07 Mar 2025
ahhklarygn(civfwgjsko) = spgotykysc gecsoiapep (kqyuuhujzb )
Phase 3
384
ujsfkckkrb(egpgxgmlpj) = ytnyzvqver pfeycilrwe (yevixekeod, -85.40 to -74.35)
Non-inferior
25 Sep 2024
ujsfkckkrb(egpgxgmlpj) = qqqovzqmlm pfeycilrwe (yevixekeod, -86.01 to -75.10)
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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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

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