Home/Biosimilar Atlas/Denosumab/Ospomyv / Xbryk / Obodence

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 · Company profile
FDAFeb 2025approved
EMAFeb 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
DenosumabmoleculeSamsung Bioepisdeveloper3 of 7markets2trials behind it9other products, same developer11rival developers in its markets

About Ospomyv / Xbryk / Obodence

Ospomyv and Xbryk are Samsung Bioepis's denosumab, approved in the United States in February 2025 and interchangeable since October that year. In Europe the osteoporosis form is called Obodence and the cancer form Xbryk, both approved in February 2025. They arrived in the second wave, eleven months after Sandoz.

Status by market

FDA

United States · Ospomyv

US Food and Drug AdministrationApproved
Brand
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
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 · Xbryk

US Food and Drug AdministrationApproved
Brand
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
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 · Obodence

European Medicines Agency and European CommissionApproved
Brand
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) · checked Sep 2026
EMA

European Union · Xbryk

European Medicines Agency and European CommissionApproved
Brand
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 (EMA) · checked Sep 2026
MHRA

United Kingdom · Obodence

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Obodence
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 · Xbryk

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Xbryk
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 Ospomyv / Xbryk / Obodence by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
SB16Samsung BioepisProliaPhase 3Comparative efficacyCompletedNov 2020Jun 2022NCT04664959
SB16Samsung BioepisProliaPhase 1Comparative PKCompletedOct 2020Nov 2022NCT04621318

Other developers in the same markets

Where Ospomyv / Xbryk / Obodence holds an approval, these are the other denosumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA9Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), Celltrion (Stoboclo / Osenvelt), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
EMA11Alvotech (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), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
MHRA10Alvotech (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), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)

Same developer, other molecules

Other biosimilars in the Atlas developed by Samsung Bioepis: Aybintio, Byooviz, Epysqli, Eticovo / Benepali, Hadlima / Imraldi, Ontruzant, Opuviz, Pyzchiva, Renflexis / Flixabi.

Chronology

Sources

All denosumab biosimilars

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Data current to September 2026.