Home/Biosimilar Atlas/Pertuzumab/Enzene Biosciences pertuzumab

Enzene Biosciences pertuzumab

Pertuzumab biosimilar developed by Enzene Biosciences (Alkem). Reference product Perjeta.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Enzene Biosciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJun 2025permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Enzene Biosciences pertuzumab

Enzene received its pertuzumab permission in India in June 2025, the third Indian company to make it, adding to its adalimumab, bevacizumab, denosumab and ranibizumab.

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
Enzene Biosciences Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2025
Application or permission
MF/BIO/25/000085
Indications as licensed
HER2-positive metastatic breast cancer
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 Enzene Biosciences pertuzumab holds an approval, these are the other pertuzumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO2Intas Pharmaceuticals (Intas pertuzumab), Zydus Lifesciences (Zydus pertuzumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Enzene Biosciences: Enzene Biosciences adalimumab, Enzene Biosciences bevacizumab, Enzene Biosciences ranibizumab, Enzene Biosciences teriparatide, Osqay / Enzene denosumab.

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.

Talk to a biosimilar regulatory consultant
Data current to September 2026.