Bosaya / Aukelso / Vevzuo / Evfraxy
Denosumab biosimilar developed by Biocon Biologics, development code Bmab 1000. Reference product Prolia and Xgeva.
Brands by market: Bosaya and Aukelso (USA); Vevzuo and Evfraxy (EU) · Commercial partner or holder: Biocon Biologics · 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
About Bosaya / Aukelso / Vevzuo / Evfraxy
Bosaya and Aukelso are Biocon's denosumab in the United States, approved in September 2025 and interchangeable from October. In Europe the same product is called Vevzuo and Evfraxy, approved in June 2025. It extends Biocon's portfolio from its original insulins and cancer antibodies into bone health.
Status by market
FDA
United States · Bosaya
US Food and Drug AdministrationApprovedBrand
Bosaya
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Sep 2025
Application or permission
761436
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 · Aukelso
US Food and Drug AdministrationApprovedBrand
Aukelso
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Sep 2025
Application or permission
761436
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 · Vevzuo
European Medicines Agency and European CommissionApprovedBrand
Vevzuo
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006534
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Evfraxy
European Medicines Agency and European CommissionApprovedBrand
Evfraxy
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006526
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Evfraxy
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Evfraxy
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 · Vevzuo
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Vevzuo
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.
Other developers in the same markets
Where Bosaya / Aukelso / Vevzuo / Evfraxy holds an approval, these are the other denosumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 9 | Celltrion (Stoboclo / Osenvelt), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), 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) |
| EMA | 11 | Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), 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), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
| MHRA | 10 | Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), Celltrion (Stoboclo / Osenvelt), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), 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 Biocon Biologics: Biocon human insulin, Fulphila / Vivlipeg / Biopegfil, Jobevne / Abevmy / Krabeva, Kirsty, Ogivri / CANMAb, Semglee, Yesafili, Yesintek / Usrenty.
Chronology
- EMAJun 2025Authorised by the European Commission as Vevzuo
- EMAJun 2025Authorised by the European Commission as Evfraxy
- FDASep 2025Approved by FDA as Aukelso
- FDASep 2025Approved by FDA as Bosaya
- FDAOct 2025Aukelso designated interchangeable
- FDAOct 2025Bosaya designated interchangeable
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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