Stoboclo / Osenvelt
Denosumab biosimilar developed by Celltrion, development code CT-P41. Reference product Prolia and Xgeva.
Brands by market: Stoboclo and Osenvelt (USA, EU) · Commercial partner or holder: Celltrion
FDAFeb 2025approved
EMAFeb 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Stoboclo
US Food and Drug AdministrationApprovedBrand
Stoboclo
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Feb 2025
Application or permission
761404
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
60 mg/mL PFS
Source
S001, S016
FDA
United States · Osenvelt
US Food and Drug AdministrationApprovedBrand
Osenvelt
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Feb 2025
Application or permission
761404
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
120 mg/1.7 mL vial
Source
S001, S016
EMA
European Union · Stoboclo
European Medicines Agency and European CommissionApprovedBrand
Stoboclo
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/006156
Presentations
see SmPC
Source
S017
EMA
European Union · Osenvelt
European Medicines Agency and European CommissionApprovedBrand
Osenvelt
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/006157
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 Osenvelt
- EMAFeb 2025Authorised by the European Commission as Stoboclo
- FDAFeb 2025Approved by FDA as Osenvelt
- FDAFeb 2025Approved by FDA as Stoboclo
- FDAOct 2025Osenvelt designated interchangeable
- FDAOct 2025Stoboclo 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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