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Intas rituximab

Rituximab biosimilar developed by Intas Pharmaceuticals. Reference product MabThera (Rituxan in the United States).

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Intas Pharmaceuticals · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOFeb 2013permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
RituximabmoleculeIntas Pharmaceuticalsdeveloper1 of 7markets0trials behind it11other products, same developer6rival developers in its markets

About Intas rituximab

Intas received its rituximab permission in India in February 2013, for lymphoma, with leukaemia added later that year. It is one of the earliest permissions in the published Indian lists. Intas's rituximab remains an Indian product.

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 OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Feb 2013
Application or permission
MF-05/2013; BULK-06/2013; additional indication 9 October 2013
Indications as licensed
Relapsed or chemoresistant indolent NHL, previously untreated follicular lymphoma, DLBCL; CLL added October 2013
Presentations
100 mg and 500 mg vials (10 mg/mL)
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Intas rituximab holds an approval, these are the other rituximab biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO6Biocad (Biocad rituximab), Hetero (Hetero 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 Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas etanercept, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas pertuzumab, Intas trastuzumab, Osvyrti / Jubereq, Pelgraz / Ennumo, Rexatilux / Razumab, Sondelbay / Intas teriparatide.

Chronology

Sources

All rituximab biosimilars

Planning rituximab biosimilar development?

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Data current to September 2026.