Boncresa / Oziltus / Denbrayce / Izamby
Denosumab biosimilar developed by mAbxience, development code MB09. Reference product Prolia and Xgeva.
Brands by market: Boncresa and Oziltus (USA); Denbrayce and Izamby (EU, mAbxience); Zadenvi and Enwylma (EU, Zentiva) · Commercial partner or holder: Amneal (USA); Zentiva (EU)
FDADec 2025approved
EMAJun 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Boncresa
US Food and Drug AdministrationApprovedBrand
Boncresa
Holder or applicant
Amneal Pharmaceuticals LLC
Pathway
351(k)
Approved
Dec 2025
Application or permission
761456
Licence type
351(k) interchangeable, designated Dec 2025
Presentations
60 mg/mL PFS
Source
S001, S016
FDA
United States · Oziltus
US Food and Drug AdministrationApprovedBrand
Oziltus
Holder or applicant
Amneal Pharmaceuticals LLC
Pathway
351(k)
Approved
Dec 2025
Application or permission
761457
Licence type
351(k) interchangeable, designated Dec 2025
Presentations
120 mg/1.7 mL vial
Source
S001, S016
EMA
European Union · Denbrayce
European Medicines Agency and European CommissionApprovedBrand
Denbrayce
Holder or applicant
Mabxience Research SL
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006199
Presentations
see SmPC
Source
S017
EMA
European Union · Izamby
European Medicines Agency and European CommissionApprovedBrand
Izamby
Holder or applicant
Mabxience Research SL
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006152
Presentations
see SmPC
Source
S017
EMA
European Union · Zadenvi
European Medicines Agency and European CommissionApprovedBrand
Zadenvi
Holder or applicant
Zentiva k.s.
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006377
Presentations
see SmPC
Note
Zentiva licence of the mAbxience product.
Source
S017
EMA
European Union · Enwylma
European Medicines Agency and European CommissionApprovedBrand
Enwylma
Holder or applicant
Zentiva k.s.
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006376
Presentations
see SmPC
Note
Zentiva licence of the mAbxience product.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJun 2025Authorised by the European Commission as Denbrayce
- EMAJun 2025Authorised by the European Commission as Enwylma
- EMAJun 2025Authorised by the European Commission as Izamby
- EMAJun 2025Authorised by the European Commission as Zadenvi
- FDADec 2025Approved by FDA as Boncresa
- FDADec 2025Approved by FDA as Oziltus
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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