Zydus trastuzumab
Trastuzumab biosimilar developed by Cadila Healthcare (Zydus Lifesciences). Reference product Herceptin.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Zydus Lifesciences
FDAnot listed
EMAnot listed
CDSCOOct 2015permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
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
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOOct 2015CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning trastuzumab 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 consultantData current to September 2026.