Home/Biosimilar Atlas/Denosumab/Enoby / Xtrenbo / Junod / Yaxwer

Enoby / Xtrenbo / Junod / Yaxwer

Denosumab biosimilar developed by Gedeon Richter, development code RGB-14. Reference product Prolia and Xgeva.

Brands by market: Enoby and Xtrenbo (USA); Junod and Yaxwer (EU) · Commercial partner or holder: Hikma (USA) · Company profile
FDASep 2025approved
EMAJun 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
DenosumabmoleculeGedeon Richterdeveloper3 of 7markets1trial behind it3other products, same developer11rival developers in its markets

About Enoby / Xtrenbo / Junod / Yaxwer

Enoby and Xtrenbo are the denosumab developed by Gedeon Richter of Hungary and sold in the United States by Hikma, approved in September 2025 and interchangeable from October. In Europe Richter sells them itself as Junod and Yaxwer, approved in June 2025. Richter, better known for women's health medicines, has a growing biosimilar range that also includes teriparatide, tocilizumab and ustekinumab.

Status by market

FDA

United States · Enoby

US Food and Drug AdministrationApproved
Brand
Enoby
Holder or applicant
Hikma Pharmaceuticals USA Inc.
Pathway
351(k)
Approved
Sep 2025
Application or permission
761439
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 · Xtrenbo

US Food and Drug AdministrationApproved
Brand
Xtrenbo
Holder or applicant
Hikma Pharmaceuticals USA Inc.
Pathway
351(k)
Approved
Sep 2025
Application or permission
761439
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 · Junod

European Medicines Agency and European CommissionApproved
Brand
Junod
Holder or applicant
Gedeon Richter Plc.
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006436
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Yaxwer

European Medicines Agency and European CommissionApproved
Brand
Yaxwer
Holder or applicant
Gedeon Richter Plc.
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006437
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Junod

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Junod
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 · Yaxwer

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Yaxwer
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 Enoby / Xtrenbo / Junod / Yaxwer by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
RGB-14Gedeon RichterProliaPhase 3Comparative efficacyCompletedSep 2021Oct 2023NCT05087030

Other developers in the same markets

Where Enoby / Xtrenbo / Junod / Yaxwer 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), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), 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), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), 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), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), 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 Gedeon Richter: Terrosa / Movymia, Tuyory, Usymro.

Chronology

Sources

All denosumab biosimilars

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Data current to September 2026.