RxBNProlia
denosumab
1 reference · 10 interchangeable
Reference Product
Prolia
denosumab
351(a) Reference Product (Approval Date 1-Jun-2010)
ApplicantAmgen Inc.
BLA125320
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Prolia
denosumab
351(a) Reference Product (Approval Date 1-Jun-2010)
ApplicantAmgen Inc.
BLA125320
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Interchangeable Biosimilars
Bildyos
denosumab-nxxp
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantShanghai Henlius Biotech, Inc.
BLA761444
RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Bildyos
denosumab-nxxp
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantShanghai Henlius Biotech, Inc.
BLA761444
·RouteSubcutaneous
Presentation
Pre-Filled SyringeSingle-Dose Vial
Boncresa
denosumab-mobz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 19-Dec-2025)
ApplicantAmneal Pharmaceuticals LLC
BLA761456
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Boncresa
denosumab-mobz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 19-Dec-2025)
ApplicantAmneal Pharmaceuticals LLC
BLA761456
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Bosaya
denosumab-kyqq
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantBiocon Biologics Inc.
BLA761436
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Bosaya
denosumab-kyqq
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantBiocon Biologics Inc.
BLA761436
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Conexxence
denosumab-bnht
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantFresenius Kabi USA, LLC
BLA761398
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Conexxence
denosumab-bnht
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantFresenius Kabi USA, LLC
BLA761398
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Enoby
denosumab-qbde
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantHikma Pharmaceuticals USA Inc.
BLA761439
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Enoby
denosumab-qbde
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantHikma Pharmaceuticals USA Inc.
BLA761439
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Jubbonti
denosumab-bbdz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Mar-2024)
ApplicantSandoz Inc.
BLA761362
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Jubbonti
denosumab-bbdz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 5-Mar-2024)
ApplicantSandoz Inc.
BLA761362
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Ospomyv
denosumab-dssb
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761392
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Ospomyv
denosumab-dssb
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761392
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Osvyrti
denosumab-desu
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantAccord BioPharma Inc.
BLA761424
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Osvyrti
denosumab-desu
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantAccord BioPharma Inc.
BLA761424
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Ponlimsi
denosumab-adet
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 27-Mar-2026)
ApplicantTeva Pharmaceuticals, Inc.
BLA761385
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Ponlimsi
denosumab-adet
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 27-Mar-2026)
ApplicantTeva Pharmaceuticals, Inc.
BLA761385
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Stoboclo
denosumab-bmwo
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantCELLTRION, Inc.
BLA761404
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Stoboclo
denosumab-bmwo
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Oct-2025)
ApplicantCELLTRION, Inc.
BLA761404
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Biosimilars (not interchangeable)
No non-interchangeable biosimilars in this group.