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) · Company profile
FDANot listed
EMANov 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 2 of 7 markets
Connections
DenosumabmoleculeAlvotechdeveloper2 of 7markets3trials behind it4other products, same developer11rival developers in its markets

About Zvogra / Kefdensis / Xbonzy / Acvybra

Alvotech's denosumab was approved in Europe in November 2025 under four names: Zvogra and Kefdensis through Stada, and Xbonzy and Acvybra through Dr. Reddy's. Alvotech, based in Iceland, licenses all its products to partners. This is Dr. Reddy's first European biosimilar sourced from another developer. The product has not yet been filed in the United States.

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) · checked Sep 2026
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) · checked Sep 2026
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) · checked Sep 2026
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 (EMA) · checked Sep 2026
MHRA

United Kingdom · Acvybra

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Acvybra
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 · Xbonzy

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Xbonzy
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 · Zvogra

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Zvogra
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 · Kefdensis

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Kefdensis
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

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Zvogra / Kefdensis / Xbonzy / Acvybra by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
AVT03AlvotechProliaPhase 3Comparative efficacyCompletedAug 2022May 2024NCT05395091
AVT03AlvotechXgevaPhase 1Comparative PKCompletedJul 2023Apr 2024NCT05876949
AVT03AlvotechProliaPhase 1Comparative PKCompletedJun 2022Oct 2023NCT05126784

Other developers in the same markets

Where Zvogra / Kefdensis / Xbonzy / Acvybra holds an approval, these are the other denosumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
EMA11Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), 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)
MHRA10Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), 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 Alvotech: Afiveg / Mynzepli, Gobivaz / Gotenfia, Selarsdi / Uzpruvo / Usgena, Simlandi / Hukyndra / Libmyris.

Chronology

Sources

All denosumab biosimilars

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 consultant
Data current to September 2026.