Zydus trastuzumab

Trastuzumab biosimilar developed by Cadila Healthcare (Zydus Lifesciences). Reference product Herceptin.

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
CDSCOOct 2015permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Zydus trastuzumab

Zydus, then Cadila Healthcare, received its trastuzumab permission in India in October 2015 for advanced breast cancer. It followed Biocon and Reliance as the third Indian manufacturer. The product is sold in India and has not been filed with the regulators outside India.

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
Cadila Healthcare Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Oct 2015
Application or permission
MF-209/2015; BULK-210/2015
Indications as licensed
HER2-positive metastatic breast cancer
Presentations
150 mg single-use and 440 mg multi-use vials
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
CDSCO6Biocad (Biocad trastuzumab), Biocon Biologics (Ogivri / CANMAb), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Dr. Reddy's Laboratories (Dr. Reddy's trastuzumab), Intas Pharmaceuticals (Intas trastuzumab), Reliance Life Sciences (Reliance Life Sciences trastuzumab)

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 pertuzumab, Zydus rituximab, Zydus teriparatide.

Chronology

Sources

All trastuzumab biosimilars

Planning trastuzumab biosimilar development?

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Data current to September 2026.