Intas rituximab
Rituximab biosimilar developed by Intas Pharmaceuticals. Reference product MabThera (Rituxan in the United States).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Intas Pharmaceuticals
FDAnot listed
EMAnot listed
CDSCOFeb 2013permitted
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
Feb 2013
Application or permission
MF-05/2013; BULK-06/2013; additional indication 9 October 2013
Indications as licensed
Relapsed or chemoresistant indolent NHL, previously untreated follicular lymphoma, DLBCL; CLL added October 2013
Presentations
100 mg and 500 mg vials (10 mg/mL)
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOFeb 2013CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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