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Virchow Biotech rituximab

Rituximab biosimilar developed by Virchow Biotech. Reference product MabThera (Rituxan in the United States).

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Virchow Biotech · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOAug 2025permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
RituximabmoleculeVirchow Biotechdeveloper1 of 7markets0trials behind it1other products, same developer6rival developers in its markets

About Virchow Biotech rituximab

Virchow Biotech received its rituximab permission in India in August 2025, covering both the cancer and the immune uses. Virchow is a Hyderabad company that also received a pegfilgrastim permission in 2021.

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
Virchow Biotech Private Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2025
Application or permission
MF/BIO/25/000114
Indications as licensed
RA, NHL, CLL, GPA and MPA
Presentations
100 mg/10 mL and 500 mg/50 mL
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Virchow Biotech 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), Zenotech Laboratories (Zenotech rituximab), Zydus Lifesciences (Zydus rituximab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Virchow Biotech: Virchow Biotech pegfilgrastim.

Chronology

Sources

All rituximab biosimilars

Planning rituximab biosimilar development?

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Data current to September 2026.