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Zydus rituximab

Rituximab biosimilar developed by Zydus Lifesciences. Reference product MabThera (Rituxan in the United States).

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Zydus Lifesciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJun 2025permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
RituximabmoleculeZydus Lifesciencesdeveloper1 of 7markets0trials behind it10other products, same developer6rival developers in its markets

About Zydus rituximab

Zydus received its rituximab permission in India in June 2025, for rheumatoid arthritis with methotrexate rather than for cancer, an unusual choice of first indication. It is the most recent of Zydus's Indian biosimilar permissions.

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
Zydus Lifesciences Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2025
Application or permission
MF/BIO/25/000093
Indications as licensed
Rheumatoid arthritis in combination with methotrexate
Presentations
100 mg/10 mL and 500 mg/50 mL (10 mg/mL)
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
CDSCO6Biocad (Biocad rituximab), Hetero (Hetero rituximab), Intas Pharmaceuticals (Intas rituximab), Reliance Life Sciences (Reliance Life Sciences rituximab), Virchow Biotech (Virchow Biotech rituximab), Zenotech Laboratories (Zenotech rituximab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Zydus Lifesciences: Exemptia / Cadalimab, Nufymco, Zydus aflibercept, Zydus bevacizumab, Zydus epoetin, Zydus follitropin alfa, Zydus peginterferon alfa-2b, Zydus pertuzumab, Zydus teriparatide, Zydus trastuzumab.

Chronology

Sources

All rituximab biosimilars

Planning rituximab biosimilar development?

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Data current to September 2026.