RxBNHumira
adalimumab
1 reference · 8 interchangeable · 2 biosimilar-only
Reference Product
Humira
adalimumab
351(a) Reference Product (Approval Date 31-Dec-2002)
ApplicantAbbVie Inc.
BLA125057
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Humira
adalimumab
351(a) Reference Product (Approval Date 31-Dec-2002)
ApplicantAbbVie Inc.
BLA125057
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Interchangeable Biosimilars
Abrilada
adalimumab-afzb
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 4-Oct-2023)
ApplicantPfizer Inc.
BLA761118
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Abrilada
adalimumab-afzb
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 4-Oct-2023)
ApplicantPfizer Inc.
BLA761118
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Amjevita
adalimumab-atto
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 20-Aug-2024)
ApplicantAmgen Inc.
BLA761024
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Amjevita
adalimumab-atto
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 20-Aug-2024)
ApplicantAmgen Inc.
BLA761024
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Cyltezo
adalimumab-adbm
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 20-May-2025)
ApplicantBoehringer Ingelheim Pharmaceuticals, Inc.
BLA761058
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Cyltezo
adalimumab-adbm
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 20-May-2025)
ApplicantBoehringer Ingelheim Pharmaceuticals, Inc.
BLA761058
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Hadlima
adalimumab-bwwd
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 20-May-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761059
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Hadlima
adalimumab-bwwd
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 20-May-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761059
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Hulio
adalimumab-fkjp
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Feb-2025)
ApplicantBiocon Biologics Inc.
BLA761154
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Hulio
adalimumab-fkjp
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Feb-2025)
ApplicantBiocon Biologics Inc.
BLA761154
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Hyrimoz
adalimumab-adaz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Jul-2025)
ApplicantSandoz Inc.
BLA761071
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Hyrimoz
adalimumab-adaz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Jul-2025)
ApplicantSandoz Inc.
BLA761071
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Simlandi
adalimumab-ryvk
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 7-Apr-2025)
ApplicantAlvotech USA Inc.
BLA761299
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Simlandi
adalimumab-ryvk
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 7-Apr-2025)
ApplicantAlvotech USA Inc.
BLA761299
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Yuflyma
adalimumab-aaty
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 21-May-2025)
ApplicantCELLTRION, Inc.
BLA761219
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Yuflyma
adalimumab-aaty
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 21-May-2025)
ApplicantCELLTRION, Inc.
BLA761219
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Biosimilars (not interchangeable)
Idacio
adalimumab-aacf
351(k) Biosimilar (Approval Date 13-Dec-2022)
ApplicantFresenius Kabi USA, LLC
BLA761255
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Idacio
adalimumab-aacf
351(k) Biosimilar (Approval Date 13-Dec-2022)
ApplicantFresenius Kabi USA, LLC
BLA761255
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Yusimry
adalimumab-aqvh
351(k) Biosimilar (Approval Date 17-Dec-2021)
ApplicantEmerge Bioscience Pte. Ltd.
BLA761216
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Yusimry
adalimumab-aqvh
351(k) Biosimilar (Approval Date 17-Dec-2021)
ApplicantEmerge Bioscience Pte. Ltd.
BLA761216
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe