Jubbonti / Wyost
Denosumab biosimilar developed by Sandoz, development code GP2411. Reference product Prolia and Xgeva.
Brands by market: Jubbonti and Wyost (USA, EU); Jubbonti (UAE); Rolcya (EU) · Commercial partner or holder: Sandoz · Company profile
FDAMar 2024approved
EMAMay 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCFeb 2024approved
CDSCONot listed
EDEJun 2026registered
Approved or registered in 5 of 7 markets
Connections
About Jubbonti / Wyost
Jubbonti and Wyost are Sandoz's denosumab, the first denosumab biosimilar approved in the United States, in March 2024, and interchangeable from the day of approval. The two names match the two uses of the reference product, osteoporosis and cancer. Europe approved them two months later, and Sandoz later added a third European name, Rolcya. Canada approved them the same spring, and Jubbonti was registered in the UAE in 2026. Sandoz was first to market in every Western region.
Status by market
FDA
United States · Jubbonti
US Food and Drug AdministrationApprovedBrand
Jubbonti
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Mar 2024
Application or permission
761362
Licence type
351(k) interchangeable, designated Mar 2024
Reference product in the Purple Book
Prolia
Marketing status (Purple Book)
Prescription, marketed
First-interchangeable exclusivity expiry
Oct 2025
Presentations
60 mg/mL PFS
Remarks
First denosumab biosimilar; interchangeable on licensure.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
FDA
United States · Wyost
US Food and Drug AdministrationApprovedBrand
Wyost
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Mar 2024
Application or permission
761362
Licence type
351(k) interchangeable, designated Mar 2024
Reference product in the Purple Book
Xgeva
Marketing status (Purple Book)
Prescription, marketed
First-interchangeable exclusivity expiry
Oct 2025
Presentations
120 mg/1.7 mL vial
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union · Jubbonti
European Medicines Agency and European CommissionApprovedBrand
Jubbonti
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
May 2024
Application or permission
EMEA/H/C/005964
Indications as licensed
Osteoporosis, bone loss from hormone ablation
Presentations
see SmPC
Remarks
First EU denosumab biosimilar.
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Wyost
European Medicines Agency and European CommissionApprovedBrand
Wyost
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
May 2024
Application or permission
EMEA/H/C/006378
Indications as licensed
Skeletal-related events, giant cell tumour of bone
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Rolcya
European Medicines Agency and European CommissionApprovedBrand
Rolcya
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Jul 2025
Application or permission
EMEA/H/C/006507
Presentations
see SmPC
Remarks
Third Sandoz brand.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Jubbonti
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Jubbonti
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 · Wyost
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Wyost
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 · Jubbonti
Health CanadaApprovedBrand
Jubbonti
Holder or applicant
Sandoz Canada Incorporated
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Feb 2024
Application or permission
DIN 02545411
Presentations
60 mg
Source
S022 (Health Canada) · checked Sep 2026
HC
Canada · Wyost
Health CanadaApprovedBrand
Wyost
Holder or applicant
Sandoz Canada Incorporated
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Mar 2024
Application or permission
DIN 02545764
Presentations
120 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Jubbonti
Emirates Drug EstablishmentRegisteredBrand
Jubbonti
Holder or applicant
Novartis Pharmaceutical Manufacturing GmbH (Sandoz) · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
Jun 2026
Presentations
60 mg/mL
Source
S018 (UAE Emirates Drug Establishment) · checked Sep 2026
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Jubbonti / Wyost 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 |
|---|---|---|---|---|---|---|---|---|
| GP2411 | Sandoz | Prolia | Phase 3 | Comparative efficacy | Completed | Jul 2019 | Apr 2022 | NCT03974100 |
Other developers in the same markets
Where Jubbonti / Wyost 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), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
| 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), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
| 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), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
| HC | 3 | Apotex (Denoza), Celltrion (Stoboclo / Osenvelt), Shanghai Henlius Biotech (Bildyos / Bilprevda) |
| EDE | 1 | Intas Pharmaceuticals (Osvyrti / Jubereq) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Sandoz: Binocrit / Epoetin alfa Hexal / Abseamed, Enzeevu / Afqlir, Erelzi, Hyrimoz / Hefiya, Inclunox, Omnitrope, Rixathon / Riximyo, Zarxio / Zarzio, Ziextenzo.
Chronology
- HCFeb 2024Notice of Compliance, Health Canada as Jubbonti
- HCMar 2024Notice of Compliance, Health Canada as Wyost
- FDAMar 2024Approved by FDA as Jubbonti
- FDAMar 2024Approved by FDA as Wyost
- EMAMay 2024Authorised by the European Commission as Jubbonti
- EMAMay 2024Authorised by the European Commission as Wyost
- EMAJul 2025Authorised by the European Commission as Rolcya
- EDEJun 2026Registered in the UAE as Jubbonti
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)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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