Dr. Reddy's trastuzumab
Trastuzumab biosimilar developed by Dr. Reddy's Laboratories. Reference product Herceptin.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Dr. Reddy's Laboratories
FDAnot listed
EMAnot listed
CDSCOMar 2018permitted
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
Dr. Reddy's Laboratories Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2018
Application or permission
MF-69/2018; BULK-70/2018
Indications as licensed
HER2-positive early and metastatic breast cancer
Presentations
150 mg and 440 mg vials
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMar 2018CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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