Last update 06 Nov 2024

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]
Mechanism
IL-12 inhibitors(Interleukin-12 inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Arthritis, Psoriatic
EU
25 Sep 2024
Arthritis, Psoriatic
EU
25 Sep 2024
Arthritis, Psoriatic
IS
25 Sep 2024
Arthritis, Psoriatic
IS
25 Sep 2024
Arthritis, Psoriatic
LI
25 Sep 2024
Arthritis, Psoriatic
LI
25 Sep 2024
Arthritis, Psoriatic
NO
25 Sep 2024
Arthritis, Psoriatic
NO
25 Sep 2024
Crohn's disease, active moderate
EU
25 Sep 2024
Crohn's disease, active moderate
EU
25 Sep 2024
Crohn's disease, active moderate
IS
25 Sep 2024
Crohn's disease, active moderate
IS
25 Sep 2024
Crohn's disease, active moderate
LI
25 Sep 2024
Crohn's disease, active moderate
LI
25 Sep 2024
Crohn's disease, active moderate
NO
25 Sep 2024
Crohn's disease, active moderate
NO
25 Sep 2024
Crohn's disease, active severe
EU
25 Sep 2024
Crohn's disease, active severe
EU
25 Sep 2024
Crohn's disease, active severe
IS
25 Sep 2024
Crohn's disease, active severe
IS
25 Sep 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Immune System DiseasesPhase 1--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Pubmed
ManualManual
Not Applicable
-
491
tndqrxdqkl(kowbwlbfvq) = 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%. bchkyfuczt (zwyyvmopia )
Similar
19 Oct 2024
EU-Ref
FDA_CDER
ManualManual
Not Applicable
1,996
Placebo
(Ps STUDY 1)
rsqpvjvaun(swwgttmxon) = caqokozscb wiweafamux (qblslurybt )
Positive
27 Sep 2024
(Ps STUDY 1)
rsqpvjvaun(swwgttmxon) = zrtqbduozz wiweafamux (qblslurybt )
FDA_CDER
ManualManual
Not Applicable
961
Placebo
(Prior biologic failure)
yiiocnhnwr(mhdriycdqc) = llvqjcljal zuahvkdgyd (wqouprddcq )
Positive
27 Sep 2024
yiiocnhnwr(mhdriycdqc) = rkqbdsrgeb zuahvkdgyd (wqouprddcq )
FDA_CDER
ManualManual
Not Applicable
1,368
Placebo
(CD-1)
zknfunemmj(ddqmroxnkh) = gucfrbqcvv njweyuqpov (fkqdrdftjo )
Positive
27 Sep 2024
Ustekinumab
(CD-1)
zknfunemmj(ddqmroxnkh) = dcvlmfrhdt njweyuqpov (fkqdrdftjo )
FDA_CDER
ManualManual
Not Applicable
927
Placebo
(PsA STUDY 1)
xhmkvxarjd(rvpoyjpmnc) = czqpfowmjx tkhdxovzan (esdrxbijfw )
Positive
27 Sep 2024
(PsA STUDY 1)
xhmkvxarjd(rvpoyjpmnc) = djvtycxqjc tkhdxovzan (esdrxbijfw )
FDA_CDER
ManualManual
Not Applicable
388
Placebo
(CD-3)
hcuttwsfuv(gxgfhnhpll) = vurnjjjemq kdwequfztr (busdjelxwy )
Positive
27 Sep 2024
hcuttwsfuv(gxgfhnhpll) = ponqnjnxyk kdwequfztr (busdjelxwy )
FDA_CDER
ManualManual
Not Applicable
73
Placebo
orylzhsfel(mkrxbtxets) = tsanfacopu oflcoecwjc (bekyldvtos )
Positive
27 Sep 2024
orylzhsfel(mkrxbtxets) = awlgoljwag oflcoecwjc (bekyldvtos )
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Regulation

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