Dr. Reddy's trastuzumab
Trastuzumab biosimilar developed by Dr. Reddy's Laboratories. Reference product Herceptin.
About Dr. Reddy's trastuzumab
Dr. Reddy's received its trastuzumab permission in India in March 2018, covering both early and advanced breast cancer. Dr. Reddy's has since taken its rituximab to Europe and the United States, but its trastuzumab remains an Indian product.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Dr. Reddy's trastuzumab holds an approval, these are the other trastuzumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 6 | Biocad (Biocad trastuzumab), Biocon Biologics (Ogivri / CANMAb), CuraTeQ Biologics (Dazublys / CuraTeQ 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 Dr. Reddy's Laboratories: Dr. Reddy's bevacizumab, Dr. Reddy's darbepoetin alfa, Dr. Reddy's pegfilgrastim, Teriparatide Dr. Reddy's, Zimrixby / Ituxredi.
Chronology
- CDSCOMar 2018CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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