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
FDAnot listed
EMAJun 2025authorised
CDSCOMar 2024permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Dazublys
European Medicines Agency and European CommissionApprovedBrand
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
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
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
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMar 2024CDSCO permission granted
- EMAJun 2025Authorised by the European Commission as Dazublys
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)
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