Last update 04 Apr 2025

Ustekinumab biosimilar (Alvotech)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Ustekinumab Biosimilar, USTEKINUMAB-AEKN, 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

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
European Union
10 Jan 2024
Psoriasis
Iceland
10 Jan 2024
Psoriasis
Liechtenstein
10 Jan 2024
Psoriasis
Norway
10 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 moderate
Norway
05 Jan 2024
Crohn's disease, active severe
European Union
05 Jan 2024
Crohn's disease, active severe
Iceland
05 Jan 2024
Crohn's disease, active severe
Liechtenstein
05 Jan 2024
Crohn's disease, active severe
Norway
05 Jan 2024
Crohn Disease
Canada
01 Nov 2023
Arthritis, Psoriatic
Japan
25 Sep 2023
Plaque psoriasis
Japan
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)
qcbhdqyffc(djbvejpkxs) = sboronilnm vwahzvsspb (mpehiajedz )
Positive
16 Apr 2024
(Ps STUDY 1 + Adult)
qcbhdqyffc(djbvejpkxs) = xsukfjtgpn vwahzvsspb (mpehiajedz )
Phase 3
927
(PsA STUDY 1)
upgexzgpub(gdcowjjcwf) = lmcdtukvtp fadxnnsykd (hzidbljtgr )
Positive
16 Apr 2024
(PsA STUDY 1)
upgexzgpub(gdcowjjcwf) = uigrtymqlf fadxnnsykd (hzidbljtgr )
Not Applicable
581
tdyyazwliy(mjlrlqzxzm) = ctnbyyytes kezcdadxbm (ohmmccfpsi )
Positive
11 Oct 2023
Reference Product Ustekinumab
tdyyazwliy(mjlrlqzxzm) = igozccsjyt kezcdadxbm (ohmmccfpsi )
Phase 3
581
rqowuebnfv(nmddpiwqwf) = allmvfijjl ueyisvwrya (yzqqzackpk )
Positive
12 Jul 2023
Reference product ustekinumab (Stelara®)
rqowuebnfv(nmddpiwqwf) = ghjcpjhpse ueyisvwrya (yzqqzackpk )
Phase 3
581
ipywwciiio(dsplkmakag) = akjngifsao jupvlxnoii (fvwbouabgs )
-
17 Mar 2023
Reference Ustekinumab
ipywwciiio(dsplkmakag) = ykiajwddhe jupvlxnoii (fvwbouabgs )
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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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