Ospomyv / Xbryk / Obodence
Denosumab biosimilar developed by Samsung Bioepis, development code SB16. Reference product Prolia and Xgeva.
Brands by market: Ospomyv and Xbryk (USA); Obodence and Xbryk (EU) · Commercial partner or holder: Samsung Bioepis
FDAFeb 2025approved
EMAFeb 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Ospomyv
US Food and Drug AdministrationApprovedBrand
Ospomyv
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Feb 2025
Application or permission
761392
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
60 mg/mL PFS
Source
S001, S016
FDA
United States · Xbryk
US Food and Drug AdministrationApprovedBrand
Xbryk
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Feb 2025
Application or permission
761392
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
120 mg/1.7 mL vial
Source
S001, S016
EMA
European Union · Obodence
European Medicines Agency and European CommissionApprovedBrand
Obodence
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/006424
Presentations
see SmPC
Source
S017
EMA
European Union · Xbryk
European Medicines Agency and European CommissionApprovedBrand
Xbryk
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/006468
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAFeb 2025Authorised by the European Commission as Obodence
- EMAFeb 2025Authorised by the European Commission as Xbryk
- FDAFeb 2025Approved by FDA as Ospomyv
- FDAFeb 2025Approved by FDA as Xbryk
- FDAOct 2025Ospomyv designated interchangeable
- FDAOct 2025Xbryk 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)
Planning denosumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.