Intas bevacizumab
Bevacizumab biosimilar developed by Intas Pharmaceuticals. Reference product Avastin.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Intas Pharmaceuticals
FDAnot listed
EMAnot listed
CDSCOJun 2016permitted
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
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2016
Application or permission
MF-65/2016; BULK-64/2016
Indications as licensed
First-line NSCLC with platinum chemotherapy
Presentations
100 mg/4 mL and 400 mg/16 mL
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2016CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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