Home/Biosimilar Atlas/Denosumab/Zvogra / Kefdensis / Xbonzy / Acvybra

Zvogra / Kefdensis / Xbonzy / Acvybra

Denosumab biosimilar developed by Alvotech, development code AVT03. Reference product Prolia and Xgeva.

Brands by market: Zvogra and Kefdensis (EU, Stada); Xbonzy and Acvybra (EU, Reddy Holding) · Commercial partner or holder: Stada (EU); Dr. Reddy's (EU)
FDAnot listed
EMANov 2025authorised
CDSCOnot listed
EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Zvogra

European Medicines Agency and European CommissionApproved
Brand
Zvogra
Holder or applicant
Stada Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Nov 2025
Application or permission
EMEA/H/C/006552
Presentations
see SmPC
Source
S017
EMA

European Union · Kefdensis

European Medicines Agency and European CommissionApproved
Brand
Kefdensis
Holder or applicant
Stada Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Nov 2025
Application or permission
EMEA/H/C/006490
Presentations
see SmPC
Source
S017
EMA

European Union · Xbonzy

European Medicines Agency and European CommissionApproved
Brand
Xbonzy
Holder or applicant
Reddy Holding GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2025
Application or permission
EMEA/H/C/006722
Presentations
see SmPC
Source
S017
EMA

European Union · Acvybra

European Medicines Agency and European CommissionApproved
Brand
Acvybra
Holder or applicant
Reddy Holding GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2025
Application or permission
EMEA/H/C/006734
Presentations
see SmPC
Source
S017
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All denosumab biosimilars

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Data current to September 2026.