Last update 22 Nov 2024

Ustekinumab biosimilar (Alvotech)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Ustekinumab Biosimilar, USTEKINUMAB-AEKN, Uzpruvo
+ [6]
Mechanism
IL-12 inhibitors(Interleukin-12 inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors)
Inactive Indication-
Originator Organization-
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ulcerative colitis, active moderate
US
18 Oct 2024
Ulcerative colitis, active severe
US
18 Oct 2024
Psoriasis
EU
10 Jan 2024
Psoriasis
IS
10 Jan 2024
Psoriasis
LI
10 Jan 2024
Psoriasis
NO
10 Jan 2024
Crohn's disease, active moderate
EU
05 Jan 2024
Crohn's disease, active moderate
IS
05 Jan 2024
Crohn's disease, active moderate
LI
05 Jan 2024
Crohn's disease, active moderate
NO
05 Jan 2024
Crohn's disease, active severe
EU
05 Jan 2024
Crohn's disease, active severe
IS
05 Jan 2024
Crohn's disease, active severe
LI
05 Jan 2024
Crohn's disease, active severe
NO
05 Jan 2024
Crohn Disease
CA
01 Nov 2023
Arthritis, Psoriatic
JP
25 Sep 2023
Plaque psoriasis
JP
25 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
2,069
Placebo
(Ps STUDY 1 + Adult)
ijbjbkbliv(bohxlzyjyw) = movtqrmvgl kklenwhqwo (tskiftpebg )
Positive
16 Apr 2024
(Ps STUDY 1 + Adult)
ijbjbkbliv(bohxlzyjyw) = oacjsihpbj kklenwhqwo (tskiftpebg )
Phase 3
927
(PsA STUDY 1)
kwodmgonms(noifjomvoq) = zwqpmpobbi kvjthqbijs (yrpbylrwex )
Positive
16 Apr 2024
(PsA STUDY 1)
kwodmgonms(noifjomvoq) = awdapxaslq kvjthqbijs (yrpbylrwex )
Not Applicable
581
jovuekmise(davsmxxbzh) = dkkndrtgts vwkffsiqcf (ioprwmaavp )
Positive
11 Oct 2023
Reference Product Ustekinumab
jovuekmise(davsmxxbzh) = natrtbrrmf vwkffsiqcf (ioprwmaavp )
Phase 3
581
xgmherulcw(qldsbjwzsy) = uyuulgaodu epckrqpxze (oafdpujjtn )
Positive
12 Jul 2023
xgmherulcw(qldsbjwzsy) = udtpsekpub epckrqpxze (oafdpujjtn )
Phase 3
581
iajolyjauf(kagkcismtl) = jthnxbrymg dqbboxgggs (xcxpoxmlqe )
-
17 Mar 2023
Reference Ustekinumab
iajolyjauf(kagkcismtl) = wtuflguojb dqbboxgggs (xcxpoxmlqe )
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Approval

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Regulation

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