Osvyrti / Jubereq
Denosumab biosimilar developed by Intas Pharmaceuticals, development code INTP23. Reference product Prolia and Xgeva.
Brands by market: Osvyrti and Jubereq (USA, EU, UAE); brand not published by CDSCO (India) · Commercial partner or holder: Accord BioPharma (USA); Accord Healthcare (EU, UAE)
FDAOct 2025approved
EMAMay 2025authorised
CDSCOJan 2018permitted
EDESep 2025registered
Status by market
FDA
United States · Osvyrti
US Food and Drug AdministrationApprovedBrand
Osvyrti
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Oct 2025
Application or permission
761424
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
60 mg/mL PFS
Source
S001, S016
FDA
United States · Jubereq
US Food and Drug AdministrationApprovedBrand
Jubereq
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Oct 2025
Application or permission
761424
Licence type
351(k) interchangeable, designated Oct 2025
Presentations
120 mg/1.7 mL vial
Source
S001, S016
EMA
European Union · Osvyrti
European Medicines Agency and European CommissionApprovedBrand
Osvyrti
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
May 2025
Application or permission
EMEA/H/C/006399
Presentations
see SmPC
Source
S017
EMA
European Union · Jubereq
European Medicines Agency and European CommissionApprovedBrand
Jubereq
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
May 2025
Application or permission
EMEA/H/C/006398
Presentations
see SmPC
Source
S017
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2018
Application or permission
MF-284/2017; BULK-286/2017
Indications as licensed
Postmenopausal osteoporosis, bone loss from hormone ablation
Presentations
60 mg/mL PFS and vial
Note
First denosumab biosimilar permitted in India.
Source
S014
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2021
Application or permission
MF/BIO/21/000083
Indications as licensed
Skeletal-related events, giant cell tumour of bone, hypercalcaemia of malignancy
Presentations
70 mg/mL vial (120 mg)
Note
Oncology presentation.
Source
S011
EDE
United Arab Emirates · Osvyrti
Emirates Drug EstablishmentRegisteredBrand
Osvyrti
Holder or applicant
Accord Healthcare Limited, United Kingdom · UAE supplier Arabian Ethicals Co.
Pathway
Registered medical product
Registered
Sep 2025
Presentations
60 mg/mL
Source
S018
EDE
United Arab Emirates · Jubereq
Emirates Drug EstablishmentRegisteredBrand
Jubereq
Holder or applicant
Accord Healthcare Limited, United Kingdom · UAE supplier Arabian Ethicals Co.
Pathway
Registered medical product
Registered
Sep 2025
Presentations
120 mg (70 mg/mL)
Source
S018
Chronology
- CDSCOJan 2018CDSCO permission granted
- CDSCOAug 2021CDSCO permission granted
- EMAMay 2025Authorised by the European Commission as Jubereq
- EMAMay 2025Authorised by the European Commission as Osvyrti
- EDESep 2025Registered in the UAE as Jubereq
- EDESep 2025Registered in the UAE as Osvyrti
- FDAOct 2025Approved by FDA as Jubereq
- FDAOct 2025Approved by FDA as Osvyrti
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)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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