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); Vysribli (EU); brand not published by CDSCO (India) · Commercial partner or holder: Accord BioPharma (USA); Accord Healthcare (EU, UAE) · Company profile
FDAOct 2025approved
EMAMay 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCOJan 2018permitted
EDESep 2025registered
Approved or registered in 5 of 7 markets
Connections
About Osvyrti / Jubereq
Osvyrti and Jubereq are the denosumab developed by Intas, sold in the United States, Europe and the UAE by Accord, Intas's international arm. Intas was the first company in the world to receive a denosumab permission, in India in January 2018, with the cancer dose added in 2021. Europe approved the product in May 2025, the UAE registered it in September, and the United States approved it in October, interchangeable from the start. Intas also holds a third European name, Vysribli.
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
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 · 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
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 · 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) · checked Sep 2026
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 (EMA) · checked Sep 2026
EMA
European Union · Vysribli
European Medicines Agency and European CommissionApprovedBrand
Vysribli
Holder or applicant
Intas Third Party Sales 2005 S.L.
Pathway
Centralised (Article 10(4))
Approved
Nov 2025
Application or permission
EMEA/H/C/006797
Presentations
see SmPC
Remarks
Third Intas brand, authorised as Denosumab Intas and renamed.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Jubereq
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Jubereq
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
MHRA
United Kingdom · Osvyrti
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Osvyrti
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
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
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
Remarks
First denosumab biosimilar permitted in India.
Source
S014 (CDSCO) · checked Sep 2026
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)
Remarks
Oncology presentation.
Source
S011 (CDSCO) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Osvyrti / Jubereq 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 |
|---|---|---|---|---|---|---|---|---|
| INTP23 | Intas Pharmaceuticals | Prolia | Phase 3 | Comparative efficacy | Unknown, last recruiting | Nov 2021 | Sep 2024 | NCT05419427 |
Other developers in the same markets
Where Osvyrti / Jubereq 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), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), 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), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), 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), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
| CDSCO | 4 | Enzene Biosciences (Osqay / Enzene denosumab), Hetero (Hetero denosumab), Lupin (Lupin denosumab), Reliance Life Sciences (Reliance Life Sciences denosumab) |
| EDE | 1 | Sandoz (Jubbonti / Wyost) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas etanercept, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas pertuzumab, Intas rituximab, Intas trastuzumab, Pelgraz / Ennumo, Rexatilux / Razumab, Sondelbay / Intas teriparatide.
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
- EMANov 2025Authorised by the European Commission as Vysribli
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
Planning denosumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.