Home/Biosimilar Atlas/Pertuzumab/Zydus pertuzumab

Zydus pertuzumab

Pertuzumab biosimilar developed by Zydus Lifesciences. Reference product Perjeta.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Zydus Lifesciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOApr 2024permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
PertuzumabmoleculeZydus Lifesciencesdeveloper1 of 7markets0trials behind it10other products, same developer2rival developers in its markets

About Zydus pertuzumab

Zydus received the first pertuzumab permission in the world, in India in April 2024, for advanced breast cancer, with early breast cancer added in August. Zydus makes it alongside its trastuzumab.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

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
Remarks
First pertuzumab biosimilar permitted in India.
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Zydus pertuzumab holds an approval, these are the other pertuzumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO2Enzene Biosciences (Enzene Biosciences pertuzumab), Intas Pharmaceuticals (Intas pertuzumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Zydus Lifesciences: Exemptia / Cadalimab, Nufymco, Zydus aflibercept, Zydus bevacizumab, Zydus epoetin, Zydus follitropin alfa, Zydus peginterferon alfa-2b, Zydus rituximab, Zydus teriparatide, Zydus trastuzumab.

Chronology

Sources

All pertuzumab biosimilars

Planning pertuzumab biosimilar development?

EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.

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Data current to September 2026.