Biocad rituximab
Rituximab biosimilar developed by Biocad, development code BCD-020. Reference product MabThera (Rituxan in the United States).
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: Biocad India (import)
FDAnot listed
EMAnot listed
CDSCOJul 2017permitted
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
Biocad India Pvt Ltd
Pathway
Import and marketing permission
Approved
Jul 2017
Application or permission
Import permission
Indications as licensed
NHL, RA, CLL, GPA and MPA
Presentations
100 mg and 500 mg vials
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJul 2017CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
Planning rituximab biosimilar development?
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