Bildyos / Bilprevda
Denosumab biosimilar developed by Shanghai Henlius Biotech, development code HLX14. Reference product Prolia and Xgeva.
Brands by market: Bildyos and Bilprevda (USA, EU) · Commercial partner or holder: Organon (USA, EU); Sciencepharma (EU holder)
FDAAug 2025approved
EMASep 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Bildyos
US Food and Drug AdministrationApprovedBrand
Bildyos
Holder or applicant
Shanghai Henlius Biotech, Inc.
Pathway
351(k)
Approved
Aug 2025
Application or permission
761444
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
60 mg/mL PFS
Source
S001, S016
FDA
United States · Bilprevda
US Food and Drug AdministrationApprovedBrand
Bilprevda
Holder or applicant
Shanghai Henlius Biotech, Inc.
Pathway
351(k)
Approved
Aug 2025
Application or permission
761444
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
120 mg/1.7 mL vial
Source
S001, S016
EMA
European Union · Bilprevda
European Medicines Agency and European CommissionApprovedBrand
Bilprevda
Holder or applicant
Sciencepharma Sp. z o.o
Pathway
Centralised (Article 10(4))
Approved
Sep 2025
Application or permission
EMEA/H/C/006435
Presentations
see SmPC
Source
S017
EMA
European Union · Bildyos
European Medicines Agency and European CommissionApprovedBrand
Bildyos
Holder or applicant
Sciencepharma Sp. z o.o
Pathway
Centralised (Article 10(4))
Approved
Sep 2025
Application or permission
EMEA/H/C/006434
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAAug 2025Approved by FDA as Bildyos
- FDAAug 2025Approved by FDA as Bilprevda
- EMASep 2025Authorised by the European Commission as Bildyos
- EMASep 2025Authorised by the European Commission as Bilprevda
- FDAOct 2025Bildyos designated interchangeable
- FDAOct 2025Bilprevda designated interchangeable
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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