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Denoza

Denosumab biosimilar developed by Apotex. Reference product Prolia and Xgeva.

Brands by market: Denoza (Canada) · Commercial partner or holder: Apotex

FDAnot listed

EMAnot listed

PMDAnot listed

HCMar 2026approved

CDSCOnot listed

EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

PMDA

Japan

Not listed by PMDA.

Canada · Denoza

Health CanadaApproved

Brand

Denoza

Holder or applicant

Apotex INC

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Mar 2026

Application or permission

DIN 02566265

Presentations

60 mg

Source

S022

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Chronology

HCMar 2026Notice of Compliance, Health Canada

Sources

S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)

All denosumab biosimilars

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Data current to September 2026.