RxBNXgeva
denosumab
1 reference · 9 interchangeable
Reference Product
Xgeva
denosumab
351(a) Reference Product (Approval Date 18-Nov-2010)
ApplicantAmgen Inc.
BLA125320
RouteSubcutaneous
Presentation
Single-Dose Vial
Xgeva
denosumab
351(a) Reference Product (Approval Date 18-Nov-2010)
ApplicantAmgen Inc.
BLA125320
·RouteSubcutaneous
Presentation
Single-Dose Vial
Interchangeable Biosimilars
Aukelso
denosumab-kyqq
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantBiocon Biologics Inc.
BLA761436
RouteSubcutaneous
Presentation
Single-Dose Vial
Aukelso
denosumab-kyqq
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantBiocon Biologics Inc.
BLA761436
·RouteSubcutaneous
Presentation
Single-Dose Vial
Bilprevda
denosumab-nxxp
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantShanghai Henlius Biotech, Inc.
BLA761444
RouteSubcutaneous
Presentation
Single-Dose Vial
Bilprevda
denosumab-nxxp
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantShanghai Henlius Biotech, Inc.
BLA761444
·RouteSubcutaneous
Presentation
Single-Dose Vial
Bomyntra
denosumab-bnht
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantFresenius Kabi USA, LLC
BLA761398
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Bomyntra
denosumab-bnht
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantFresenius Kabi USA, LLC
BLA761398
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Jubereq
denosumab-desu
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantAccord BioPharma Inc.
BLA761424
RouteSubcutaneous
Presentation
Single-Dose Vial
Jubereq
denosumab-desu
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantAccord BioPharma Inc.
BLA761424
·RouteSubcutaneous
Presentation
Single-Dose Vial
Osenvelt
denosumab-bmwo
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantCELLTRION, Inc.
BLA761404
RouteSubcutaneous
Presentation
Single-Dose Vial
Osenvelt
denosumab-bmwo
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantCELLTRION, Inc.
BLA761404
·RouteSubcutaneous
Presentation
Single-Dose Vial
Oziltus
denosumab-mobz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 19-Dec-2025)
ApplicantAmneal Pharmaceuticals LLC
BLA761457
RouteSubcutaneous
Presentation
Single-Dose Vial
Oziltus
denosumab-mobz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 19-Dec-2025)
ApplicantAmneal Pharmaceuticals LLC
BLA761457
·RouteSubcutaneous
Presentation
Single-Dose Vial
Wyost
denosumab-bbdz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Mar-2024)
ApplicantSandoz Inc.
BLA761362
RouteSubcutaneous
Presentation
Single-Dose Vial
Wyost
denosumab-bbdz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Mar-2024)
ApplicantSandoz Inc.
BLA761362
·RouteSubcutaneous
Presentation
Single-Dose Vial
Xbryk
denosumab-dssb
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761392
RouteSubcutaneous
Presentation
Single-Dose Vial
Xbryk
denosumab-dssb
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761392
·RouteSubcutaneous
Presentation
Single-Dose Vial
Xtrenbo
denosumab-qbde
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantHikma Pharmaceuticals USA Inc.
BLA761439
RouteSubcutaneous
Presentation
Single-Dose Vial
Xtrenbo
denosumab-qbde
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantHikma Pharmaceuticals USA Inc.
BLA761439
·RouteSubcutaneous
Presentation
Single-Dose Vial
Biosimilars (not interchangeable)
No non-interchangeable biosimilars in this group.