RxBNActemra
tocilizumab
2 reference · 2 interchangeable · 4 biosimilar-only
Reference Product
Actemra
tocilizumab
351(a) Reference Product (Approval Date 8-Jan-2010)
ApplicantGenentech, Inc.
BLA125276
RouteIntravenous
Presentation
Single-Dose Vial
Actemra
tocilizumab
351(a) Reference Product (Approval Date 8-Jan-2010)
ApplicantGenentech, Inc.
BLA125276
·RouteIntravenous
Presentation
Single-Dose Vial
Actemra
tocilizumab
351(a) Reference Product (Approval Date 21-Oct-2013)
ApplicantGenentech, Inc.
BLA125472
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Actemra
tocilizumab
351(a) Reference Product (Approval Date 21-Oct-2013)
ApplicantGenentech, Inc.
BLA125472
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Interchangeable Biosimilars
Avtozma
tocilizumab-anoh
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 24-Jan-2025)
ApplicantCELLTRION, Inc.
BLA761420
RouteIntravenous
Presentation
Single-Dose Vial
Avtozma
tocilizumab-anoh
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 24-Jan-2025)
ApplicantCELLTRION, Inc.
BLA761420
·RouteIntravenous
Presentation
Single-Dose Vial
Avtozma
tocilizumab-anoh
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 24-Jan-2025)
ApplicantCELLTRION, Inc.
BLA761498
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Avtozma
tocilizumab-anoh
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 24-Jan-2025)
ApplicantCELLTRION, Inc.
BLA761498
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Biosimilars (not interchangeable)
Avtozma
tocilizumab-anoh
351(k) Biosimilar (Approval Date 24-Jan-2025)
ApplicantCELLTRION, Inc.
BLA761498
RouteSubcutaneous
Presentation
Autoinjector
Avtozma
tocilizumab-anoh
351(k) Biosimilar (Approval Date 24-Jan-2025)
ApplicantCELLTRION, Inc.
BLA761498
·RouteSubcutaneous
Presentation
Autoinjector
Tofidence
tocilizumab-bavi
351(k) Biosimilar (Approval Date 29-Sep-2023)
ApplicantBiogen MA Inc.
BLA761354
RouteIntravenous
Presentation
Single-Dose Vial
Tofidence
tocilizumab-bavi
351(k) Biosimilar (Approval Date 29-Sep-2023)
ApplicantBiogen MA Inc.
BLA761354
·RouteIntravenous
Presentation
Single-Dose Vial
Tyenne
tocilizumab-aazg
351(k) Biosimilar (Approval Date 14-Mar-2025)
ApplicantFresenius Kabi USA, LLC
BLA761449
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Tyenne
tocilizumab-aazg
351(k) Biosimilar (Approval Date 14-Mar-2025)
ApplicantFresenius Kabi USA, LLC
BLA761449
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Tyenne
tocilizumab-aazg
351(k) Biosimilar (Approval Date 5-Mar-2024)
ApplicantFresenius Kabi USA, LLC
BLA761275
RouteIntravenous
Presentation
Single-Dose Vial
Tyenne
tocilizumab-aazg
351(k) Biosimilar (Approval Date 5-Mar-2024)
ApplicantFresenius Kabi USA, LLC
BLA761275
·RouteIntravenous
Presentation
Single-Dose Vial