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Hetero denosumab

Denosumab biosimilar developed by Hetero Biopharma. Reference product Prolia and Xgeva.

Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Hetero Biopharma
FDAnot listed
EMAnot listed
CDSCODec 2024permitted
EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Hetero Biopharma Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Dec 2024
Application or permission
MF/BIO/24/000132; bulk MF/BIO/25/000099
Indications as licensed
Skeletal-related events in bone metastases
Presentations
120 mg/1.7 mL vial (70 mg/mL)
Source
S011
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All denosumab biosimilars

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Data current to September 2026.