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) · Commercial partner or holder: Hetero Drugs · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOMar 2015permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Hetero rituximab
Hetero received its rituximab permission in India in March 2015, for lymphoma, leukaemia and rheumatoid arthritis, a month after Reliance.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Hetero rituximab holds an approval, these are the other rituximab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 6 | Biocad (Biocad rituximab), Intas Pharmaceuticals (Intas rituximab), Reliance Life Sciences (Reliance Life Sciences rituximab), Virchow Biotech (Virchow Biotech rituximab), Zenotech Laboratories (Zenotech rituximab), Zydus Lifesciences (Zydus rituximab) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Hetero: Hetero bevacizumab, Hetero darbepoetin alfa, Hetero denosumab, Mabura.
Chronology
- CDSCOMar 2015CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning rituximab biosimilar development?
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