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Zydus pertuzumab

Pertuzumab biosimilar developed by Zydus Lifesciences. Reference product Perjeta.

Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Zydus Lifesciences
FDAnot listed
EMAnot listed
CDSCOApr 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
Zydus Lifesciences Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Apr 2024
Application or permission
MF/BIO/24/000041; additional indication MF/BIO/24/000091 (August 2024)
Indications as licensed
Metastatic breast cancer at permission; early breast cancer added August 2024
Presentations
420 mg/14 mL (30 mg/mL) vial
Note
First pertuzumab biosimilar permitted in India.
Source
S011
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All pertuzumab biosimilars

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Data current to September 2026.