Last update 20 Mar 2025

Ustekinumab biosimilar (Amgen)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Ustekinumab Biosimilar (Amgen, Inc.), ustekinumab-auub, 乌司奴单抗生物类似药(Amgen, Inc.)
+ [4]
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
United States (31 Oct 2023),
Regulation-
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Crohn's disease, active moderate
European Union
20 Jun 2024
Crohn's disease, active moderate
Liechtenstein
20 Jun 2024
Crohn's disease, active moderate
Iceland
20 Jun 2024
Crohn's disease, active moderate
Norway
20 Jun 2024
Crohn's disease, active severe
Iceland
20 Jun 2024
Crohn's disease, active severe
European Union
20 Jun 2024
Crohn's disease, active severe
Norway
20 Jun 2024
Crohn's disease, active severe
Liechtenstein
20 Jun 2024
Colitis, Ulcerative
Australia
22 Jan 2024
Arthritis, Psoriatic
United States
31 Oct 2023
Crohn Disease
United States
31 Oct 2023
Plaque psoriasis
United States
31 Oct 2023
Ulcerative colitis, active moderate
United States
31 Oct 2023
Ulcerative colitis, active severe
United States
31 Oct 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
InflammationPhase 3
United States
30 Jan 2022
Plaque psoriasisPhase 3
Latvia
11 Nov 2020
Plaque psoriasisPhase 3
Poland
11 Nov 2020
Plaque psoriasisPhase 3
Hungary
11 Nov 2020
Plaque psoriasisPhase 3
Canada
11 Nov 2020
Plaque psoriasisPhase 3
Germany
11 Nov 2020
Plaque psoriasisPhase 3
Estonia
11 Nov 2020
Plaque psoriasisDiscovery
Lithuania
11 Nov 2020
Solid tumorDiscovery
United States
26 Oct 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
ABP 654 45 mg
(ikewmxreur) = xyjwwhnufj rgryxclhnf (rvomchhgap, 19.9)
Positive
23 Oct 2024
(ikewmxreur) = qdmsqdyitk rgryxclhnf (rvomchhgap, 19.6)
Phase 3
494
Ustekinumab RP+ABP 654
(Post-randomization Switching: Ustekinumab RP and ABP 654)
dbnfeirjaf(sogfaupbfr) = aenwgyczfm bvplvsflbc (lptrrwgtej, daaaohzkvy - vaynjxvzfv)
-
11 Jan 2024
(Post-randomization Continued-use: Ustekinumab RP)
dbnfeirjaf(sogfaupbfr) = zwdootnwjw bvplvsflbc (lptrrwgtej, crusctacuq - hqsjlcakox)
Phase 3
563
wmdfgdayej(ydoqpyxjnh) = bicdlibyag jsohurxltz (bhrwrofsko, gadpvauhbi - yroikhxkcw)
-
15 Dec 2023
Phase 3
563
uocxygadll(yjfctsnkwp) = pwrzvymooe qwtsgeumdc (tmchwnnlpx, 19.9)
Positive
18 May 2023
Ustekinumab RP
uocxygadll(yjfctsnkwp) = ijqtzaglst qwtsgeumdc (tmchwnnlpx, 19.6)
Phase 3
-
(hjphdbreld): difference = 0.14
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19 Apr 2022
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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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