Virchow Biotech rituximab
Rituximab biosimilar developed by Virchow Biotech. Reference product MabThera (Rituxan in the United States).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Virchow Biotech
FDAnot listed
EMAnot listed
CDSCOAug 2025permitted
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
Virchow Biotech Private Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2025
Application or permission
MF/BIO/25/000114
Indications as licensed
RA, NHL, CLL, GPA and MPA
Presentations
100 mg/10 mL and 500 mg/50 mL
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOAug 2025CDSCO permission granted
Sources
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