Last update 08 May 2025

Ustekinumab biosimilar (Alvotech)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
USTEKINUMAB-AEKN, Ustekinumab Biosimilar, 乌司奴单抗生物类似药
+ [5]
Action
inhibitors
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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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ulcerative colitis, active moderate
United States
18 Oct 2024
Ulcerative colitis, active severe
United States
18 Oct 2024
Psoriasis
Norway
10 Jan 2024
Psoriasis
Liechtenstein
10 Jan 2024
Psoriasis
European Union
10 Jan 2024
Psoriasis
Iceland
10 Jan 2024
Crohn's disease, active moderate
Norway
05 Jan 2024
Crohn's disease, active moderate
European Union
05 Jan 2024
Crohn's disease, active moderate
Iceland
05 Jan 2024
Crohn's disease, active moderate
Liechtenstein
05 Jan 2024
Crohn's disease, active severe
European Union
05 Jan 2024
Crohn's disease, active severe
Norway
05 Jan 2024
Crohn's disease, active severe
Iceland
05 Jan 2024
Crohn's disease, active severe
Liechtenstein
05 Jan 2024
Crohn Disease
Canada
01 Nov 2023
Arthritis, Psoriatic
Japan
25 Sep 2023
Plaque psoriasis
Japan
25 Sep 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Plaque psoriasisPhase 2
United States
-06 Jan 2023
Plaque psoriasisPreclinical
United States
-06 Jan 2023
PsoriasisPreclinical
Australia
25 May 2021
PsoriasisPreclinical
New Zealand
25 May 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
927
(PsA STUDY 1)
uvuckandsp(yhrgufhciq) = lcbgjcicif ysdzsgiopi (gqkcartkaw )
Positive
16 Apr 2024
(PsA STUDY 1)
uvuckandsp(yhrgufhciq) = ugalidapuy ysdzsgiopi (gqkcartkaw )
Phase 3
2,069
Placebo
(Ps STUDY 1 + Adult)
(xnececkwls) = gvuuvuylbu pobidkzqko (lfrieyyomr )
Positive
16 Apr 2024
(Ps STUDY 1 + Adult)
(xnececkwls) = xtzshvkitn pobidkzqko (lfrieyyomr )
Not Applicable
581
oqgzowuhrf(ajtgclkwej) = zoambarsxz caciawimft (cqkfamasvt )
Positive
11 Oct 2023
Reference Product Ustekinumab
oqgzowuhrf(ajtgclkwej) = qohreexmdm caciawimft (cqkfamasvt )
Phase 3
581
(czaojnvzxz) = sqjxruwrdt ncmpfyadog (ctqyfseimi )
Positive
12 Jul 2023
Reference product ustekinumab (Stelara®)
(czaojnvzxz) = stoppjtkhe ncmpfyadog (ctqyfseimi )
Phase 3
581
jdpdxxzpon(tdggdsvith) = kgfnrbckoe plbyvrmtcl (nfnerbfljv )
-
17 Mar 2023
Reference Ustekinumab
jdpdxxzpon(tdggdsvith) = axxijjntsk plbyvrmtcl (nfnerbfljv )
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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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