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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) ยท Commercial partner or holder: Zydus Lifesciences
FDAnot listed
EMAnot listed
CDSCOJun 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 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
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All rituximab biosimilars

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Data current to September 2026.