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Dazublys / CuraTeQ trastuzumab

Trastuzumab biosimilar developed by CuraTeQ Biologics (Aurobindo). Reference product Herceptin.

Brands by market: Dazublys (EU); brand not published by CDSCO (India) · Commercial partner or holder: CuraTeQ Biologics · Company profile
FDANot listed
EMAJun 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCOMar 2024permitted
EDENot listed
Approved or registered in 3 of 7 markets
Connections
TrastuzumabmoleculeCuraTeQ Biologicsdeveloper3 of 7markets0trials behind it3other products, same developer12rival developers in its markets

About Dazublys / CuraTeQ trastuzumab

Dazublys is CuraTeQ's trastuzumab, approved in Europe in 2025. CuraTeQ is the biologics arm of Aurobindo, and this was one of its first European approvals, following its filgrastim and pegfilgrastim. The same product was permitted in India in 2024, with early breast cancer and gastric cancer added in 2026.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Dazublys

European Medicines Agency and European CommissionApproved
Brand
Dazublys
Holder or applicant
CuraTeQ Biologics (Malta) Limited
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006219
Indications as licensed
Early and metastatic breast cancer, metastatic gastric cancer
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Dazublys

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Dazublys
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
150 mg vial
Source
S023 (MHRA Products) · checked Sep 2026
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
CuraTeQ Biologics Private Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2024
Application or permission
MF/BIO/24/000036; additional indications MF/BIO/26/000049
Indications as licensed
HER2-positive metastatic breast cancer at permission; early breast cancer and metastatic gastric cancer added May 2026
Presentations
150 mg and 420 mg vials
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
EMA7Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), EirGenix (Herwenda), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac)
MHRA5Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac)
CDSCO6Biocad (Biocad trastuzumab), Biocon Biologics (Ogivri / CANMAb), Dr. Reddy's Laboratories (Dr. Reddy's trastuzumab), Intas Pharmaceuticals (Intas trastuzumab), Reliance Life Sciences (Reliance Life Sciences trastuzumab), Zydus Lifesciences (Zydus trastuzumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by CuraTeQ Biologics: CuraTeQ bevacizumab, Dyrupeg / Cavoley, Zefylti.

Chronology

Sources

All trastuzumab biosimilars

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Data current to September 2026.