Enoby / Xtrenbo / Junod / Yaxwer
Denosumab biosimilar developed by Gedeon Richter, development code RGB-14. Reference product Prolia and Xgeva.
Brands by market: Enoby and Xtrenbo (USA); Junod and Yaxwer (EU) · Commercial partner or holder: Hikma (USA)
FDASep 2025approved
EMAJun 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Enoby
US Food and Drug AdministrationApprovedBrand
Enoby
Holder or applicant
Hikma Pharmaceuticals USA Inc.
Pathway
351(k)
Approved
Sep 2025
Application or permission
761439
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
60 mg/mL PFS
Source
S001, S016
FDA
United States · Xtrenbo
US Food and Drug AdministrationApprovedBrand
Xtrenbo
Holder or applicant
Hikma Pharmaceuticals USA Inc.
Pathway
351(k)
Approved
Sep 2025
Application or permission
761439
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
120 mg/1.7 mL vial
Source
S001, S016
EMA
European Union · Junod
European Medicines Agency and European CommissionApprovedBrand
Junod
Holder or applicant
Gedeon Richter Plc.
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006436
Presentations
see SmPC
Source
S017
EMA
European Union · Yaxwer
European Medicines Agency and European CommissionApprovedBrand
Yaxwer
Holder or applicant
Gedeon Richter Plc.
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006437
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJun 2025Authorised by the European Commission as Junod
- EMAJun 2025Authorised by the European Commission as Yaxwer
- FDASep 2025Approved by FDA as Enoby
- FDASep 2025Approved by FDA as Xtrenbo
- FDAOct 2025Enoby designated interchangeable
- FDAOct 2025Xtrenbo 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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