Home/Biosimilar Atlas/Denosumab/Jubbonti / Wyost

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

FDAMar 2024approved

EMAMay 2024authorised

CDSCOnot listed

EDEJun 2026registered

Status by market

FDA

United States · Jubbonti

US Food and Drug AdministrationApproved

Brand

Jubbonti

Holder or applicant

Sandoz Inc.

Pathway

351(k)

Approved

Mar 2024

Application or permission

761362

Licence type

351(k) interchangeable, designated Mar 2024

Presentations

60 mg/mL PFS

Note

First denosumab biosimilar; interchangeable on licensure.

Source

S001, S016

FDA

United States · Wyost

US Food and Drug AdministrationApproved

Brand

Wyost

Holder or applicant

Sandoz Inc.

Pathway

351(k)

Approved

Mar 2024

Application or permission

761362

Licence type

351(k) interchangeable, designated Mar 2024

Presentations

120 mg/1.7 mL vial

Source

S001, S016

EMA

European Union · Jubbonti

European Medicines Agency and European CommissionApproved

Brand

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

Note

First EU denosumab biosimilar.

Source

S017

EMA

European Union · Wyost

European Medicines Agency and European CommissionApproved

Brand

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

European Union · Rolcya

European Medicines Agency and European CommissionApproved

Brand

Rolcya

Holder or applicant

Sandoz GmbH

Pathway

Centralised (Article 10(4))

Approved

Jul 2025

Application or permission

EMEA/H/C/006507

Presentations

see SmPC

Note

Third Sandoz brand.

Source

S017

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Jubbonti

Emirates Drug EstablishmentRegistered

Brand

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

Chronology

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)

All denosumab biosimilars

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Data current to September 2026.