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) · Company profile
FDADec 2025approved
EMAJun 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
About Boncresa / Oziltus / Denbrayce / Izamby
Boncresa and Oziltus are the denosumab developed by mAbxience of Spain and sold in the United States by Amneal, approved in December 2025 and interchangeable from the start. In Europe the product carries four names: Denbrayce and Izamby under mAbxience's own licence, and Zadenvi and Enwylma under a licence to Zentiva, all approved in June 2025.
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
Reference product in the Purple Book
Prolia
Marketing status (Purple Book)
Prescription, marketed
Presentations
60 mg/mL PFS
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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
Reference product in the Purple Book
Xgeva
Marketing status (Purple Book)
Prescription, marketed
Presentations
120 mg/1.7 mL vial
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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) · checked Sep 2026
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
Remarks
Zentiva licence of the mAbxience product.
Source
S017 (EMA) · checked Sep 2026
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
Remarks
Zentiva licence of the mAbxience product.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Denbrayce
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Denbrayce
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
120 mg
Source
S023 (MHRA Products) · checked Sep 2026
MHRA
United Kingdom · Izamby
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Izamby
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
60 mg syringe
Source
S023 (MHRA Products) · checked Sep 2026
MHRA
United Kingdom · Zadenvi
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Zadenvi
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
60 mg syringe
Source
S023 (MHRA Products) · checked Sep 2026
MHRA
United Kingdom · Enwylma
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Enwylma
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
120 mg
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Boncresa / Oziltus / Denbrayce / Izamby by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| MB09 | mAbxience | Prolia | Phase 3 | Comparative efficacy | Completed | Mar 2022 | Dec 2023 | NCT05338086 |
| MB09 | mAbxience | Xgeva | Phase 1 | Comparative PK | Completed | Mar 2022 | Mar 2023 | NCT05299073 |
Other developers in the same markets
Where Boncresa / Oziltus / Denbrayce / Izamby holds an approval, these are the other denosumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 9 | Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), Celltrion (Stoboclo / Osenvelt), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma) |
| EMA | 11 | Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), Celltrion (Stoboclo / Osenvelt), Enzene Biosciences (Osqay / Enzene denosumab), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma) |
| MHRA | 10 | Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), Celltrion (Stoboclo / Osenvelt), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma) |
Same developer, other molecules
Other biosimilars in the Atlas developed by mAbxience: Alymsys / Oyavas.
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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