RxBNStelara
ustekinumab
2 reference · 16 interchangeable · 2 biosimilar-only
Reference Product
Stelara
ustekinumab
351(a) Reference Product (Approval Date 25-Sep-2009)
ApplicantJanssen Biotech, Inc.
BLA125261
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Stelara
ustekinumab
351(a) Reference Product (Approval Date 25-Sep-2009)
ApplicantJanssen Biotech, Inc.
BLA125261
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Stelara
ustekinumab
351(a) Reference Product (Approval Date 23-Sep-2016)
ApplicantJanssen Biotech, Inc.
BLA761044
RouteIntravenous
Presentation
Single-Dose Vial
Stelara
ustekinumab
351(a) Reference Product (Approval Date 23-Sep-2016)
ApplicantJanssen Biotech, Inc.
BLA761044
·RouteIntravenous
Presentation
Single-Dose Vial
Interchangeable Biosimilars
Imuldosa
ustekinumab-srlf
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Jun-2026)
ApplicantAccord BioPharma Inc.
BLA761364
RouteIntravenous
Presentation
Single-Dose Vial
Imuldosa
ustekinumab-srlf
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Jun-2026)
ApplicantAccord BioPharma Inc.
BLA761364
·RouteIntravenous
Presentation
Single-Dose Vial
Imuldosa
ustekinumab-srlf
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Jun-2026)
ApplicantAccord BioPharma Inc.
BLA761364
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Imuldosa
ustekinumab-srlf
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Jun-2026)
ApplicantAccord BioPharma Inc.
BLA761364
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Otulfi
ustekinumab-aauz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantFresenius Kabi USA, LLC
BLA761379
RouteIntravenous
Presentation
Single-Dose Vial
Otulfi
ustekinumab-aauz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantFresenius Kabi USA, LLC
BLA761379
·RouteIntravenous
Presentation
Single-Dose Vial
Otulfi
ustekinumab-aauz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantFresenius Kabi USA, LLC
BLA761379
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Otulfi
ustekinumab-aauz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantFresenius Kabi USA, LLC
BLA761379
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Pyzchiva
ustekinumab-ttwe
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761373
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Pyzchiva
ustekinumab-ttwe
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761373
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Pyzchiva
ustekinumab-ttwe
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761425
RouteIntravenous
Presentation
Single-Dose Vial
Pyzchiva
ustekinumab-ttwe
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761425
·RouteIntravenous
Presentation
Single-Dose Vial
Selarsdi
ustekinumab-aekn
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantAlvotech USA Inc.
BLA761343
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Selarsdi
ustekinumab-aekn
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantAlvotech USA Inc.
BLA761343
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Selarsdi
ustekinumab-aekn
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantAlvotech USA Inc.
BLA761343
RouteIntravenous
Presentation
Single-Dose Vial
Selarsdi
ustekinumab-aekn
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantAlvotech USA Inc.
BLA761343
·RouteIntravenous
Presentation
Single-Dose Vial
Starjemza
ustekinumab-hmny
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 22-May-2025)
ApplicantBio-Thera Solutions, Ltd.
BLA761419
RouteIntravenous
Presentation
Single-Dose Vial
Starjemza
ustekinumab-hmny
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 22-May-2025)
ApplicantBio-Thera Solutions, Ltd.
BLA761419
·RouteIntravenous
Presentation
Single-Dose Vial
Starjemza
ustekinumab-hmny
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 22-May-2025)
ApplicantBio-Thera Solutions, Ltd.
BLA761419
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Starjemza
ustekinumab-hmny
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 22-May-2025)
ApplicantBio-Thera Solutions, Ltd.
BLA761419
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Steqeyma
ustekinumab-stba
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantCELLTRION, Inc.
BLA761338
RouteIntravenous
Presentation
Single-Dose Vial
Steqeyma
ustekinumab-stba
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantCELLTRION, Inc.
BLA761338
·RouteIntravenous
Presentation
Single-Dose Vial
Steqeyma
ustekinumab-stba
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantCELLTRION, Inc.
BLA761338
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Steqeyma
ustekinumab-stba
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantCELLTRION, Inc.
BLA761338
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Wezlana
ustekinumab-auub
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 31-Oct-2023)
ApplicantAmgen Inc.
BLA761331
RouteIntravenous
Presentation
Single-Dose Vial
Wezlana
ustekinumab-auub
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 31-Oct-2023)
ApplicantAmgen Inc.
BLA761331
·RouteIntravenous
Presentation
Single-Dose Vial
Wezlana
ustekinumab-auub
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 31-Oct-2023)
ApplicantAmgen Inc.
BLA761285
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Wezlana
ustekinumab-auub
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 31-Oct-2023)
ApplicantAmgen Inc.
BLA761285
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Yesintek
ustekinumab-kfce
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantBiocon Biologics Inc.
BLA761406
RouteIntravenous
Presentation
Single-Dose Vial
Yesintek
ustekinumab-kfce
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantBiocon Biologics Inc.
BLA761406
·RouteIntravenous
Presentation
Single-Dose Vial
Yesintek
ustekinumab-kfce
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantBiocon Biologics Inc.
BLA761406
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Yesintek
ustekinumab-kfce
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 30-Apr-2025)
ApplicantBiocon Biologics Inc.
BLA761406
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Biosimilars (not interchangeable)
Wezlana
ustekinumab-auub
351(k) Biosimilar (Approval Date 26-Dec-2024)
ApplicantAmgen Inc.
BLA761285
RouteSubcutaneous
Presentation
Autoinjector
Wezlana
ustekinumab-auub
351(k) Biosimilar (Approval Date 26-Dec-2024)
ApplicantAmgen Inc.
BLA761285
·RouteSubcutaneous
Presentation
Autoinjector
Yesintek
ustekinumab-kfce
351(k) Biosimilar (Approval Date 14-Aug-2026)
ApplicantBiocon Biologics Inc.
BLA761406
RouteSubcutaneous
Presentation
Autoinjector
Yesintek
ustekinumab-kfce
351(k) Biosimilar (Approval Date 14-Aug-2026)
ApplicantBiocon Biologics Inc.
BLA761406
·RouteSubcutaneous
Presentation
Autoinjector