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
FDASep 2025approved
EMAJun 2025authorised
CDSCOnot listed
EDEnot listed
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
Presentations
60 mg/mL PFS
Source
S001, S016
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
Presentations
120 mg/1.7 mL vial
Source
S001, S016
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
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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)
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.