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Intas pertuzumab

Pertuzumab biosimilar developed by Intas Pharmaceuticals. Reference product Perjeta.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Intas Pharmaceuticals · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJan 2025permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
PertuzumabmoleculeIntas Pharmaceuticalsdeveloper1 of 7markets0trials behind it11other products, same developer2rival developers in its markets

About Intas pertuzumab

Intas received its pertuzumab permission in India in January 2025, with the use before surgery added in February 2026. It is the second Indian pertuzumab.

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
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2025
Application or permission
MF/BIO/25/000006; additional indication MF/BIO/26/000006 (February 2026)
Indications as licensed
HER2-positive metastatic breast cancer; neoadjuvant early breast cancer added February 2026
Presentations
420 mg/14 mL (30 mg/mL) vial
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
CDSCO2Enzene Biosciences (Enzene Biosciences pertuzumab), Zydus Lifesciences (Zydus pertuzumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas etanercept, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas rituximab, Intas trastuzumab, Osvyrti / Jubereq, Pelgraz / Ennumo, Rexatilux / Razumab, Sondelbay / Intas teriparatide.

Chronology

Sources

All pertuzumab biosimilars

Planning pertuzumab biosimilar development?

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Data current to September 2026.