Intas trastuzumab
Trastuzumab biosimilar developed by Intas Pharmaceuticals. Reference product Herceptin.
About Intas trastuzumab
Intas received its trastuzumab permission in India in April 2018, for advanced breast cancer. Intas is one of India's largest biosimilar makers, and several of its products have reached Europe through Accord, its European arm, but the trastuzumab has stayed in India so far.
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 Intas 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), Dr. Reddy's Laboratories (Dr. Reddy's trastuzumab), Reliance Life Sciences (Reliance Life Sciences trastuzumab), Zydus Lifesciences (Zydus trastuzumab) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas etanercept, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas pertuzumab, Intas rituximab, Osvyrti / Jubereq, Pelgraz / Ennumo, Rexatilux / Razumab, Sondelbay / Intas teriparatide.
Chronology
- CDSCOApr 2018CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning trastuzumab biosimilar development?
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