Hetero rituximab
Rituximab biosimilar developed by Hetero Drugs. Reference product MabThera (Rituxan in the United States).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Hetero Drugs
FDAnot listed
EMAnot listed
CDSCOMar 2015permitted
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
Hetero Drugs Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2015
Application or permission
MF-76/2015; BULK-78/2015
Indications as licensed
NHL, CLL, RA
Presentations
100 mg/10 mL and 500 mg/50 mL vials
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMar 2015CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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