Biocad rituximab
Rituximab biosimilar developed by Biocad, development code BCD-020. Reference product MabThera (Rituxan in the United States).
About Biocad rituximab
Biocad, the Russian developer, has held an Indian import permission for its rituximab since 2017, covering lymphoma, leukaemia and rheumatoid arthritis. It is one of three Biocad antibodies imported into India.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Biocad rituximab by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| BCD-020 | Biocad | MabThera | Phase 3 | Comparative efficacy | Completed | Dec 2012 | Jul 2015 | NCT01759030 |
| BCD-020 | Biocad | MabThera | Phase 3 | Comparative efficacy | Completed | Sep 2011 | Jan 2017 | NCT01701232 |
Other developers in the same markets
Where Biocad rituximab holds an approval, these are the other rituximab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 6 | Hetero (Hetero 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 Biocad: Biocad infliximab, Biocad trastuzumab.
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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