Home/Biosimilar Atlas/Rituximab/Zimrixby / Ituxredi

Zimrixby / Ituxredi

Rituximab biosimilar developed by Dr. Reddy's Laboratories, development code DRL_RI. Reference product MabThera (Rituxan in the United States).

Brands by market: Zimrixby (USA); Ituxredi (EU) · Commercial partner or holder: Dr. Reddy's Laboratories · Company profile
FDAJul 2026approved
EMASep 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
RituximabmoleculeDr. Reddy's Laboratoriesdeveloper3 of 7markets2trials behind it5other products, same developer4rival developers in its markets

About Zimrixby / Ituxredi

Dr. Reddy's rituximab was approved in Europe in September 2024 as Ituxredi, and in the United States in July 2026 as Zimrixby. It is the first rituximab from an Indian developer to reach either market, and follows Dr. Reddy's Reditux, sold in India since 2007 and widely regarded as the first rituximab biosimilar in the world.

Status by market

FDA

United States · Zimrixby

US Food and Drug AdministrationApproved
Brand
Zimrixby
Holder or applicant
Dr. Reddy's Laboratories SA
Pathway
351(k)
Approved
Jul 2026
Application or permission
761376
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Rituxan
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 mg/10 mL, 500 mg/50 mL
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Ituxredi

European Medicines Agency and European CommissionApproved
Brand
Ituxredi
Holder or applicant
Reddy Holding GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2024
Application or permission
EMEA/H/C/006224
Indications as licensed
NHL, CLL, RA, GPA and MPA
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Ituxredi

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Ituxredi
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
100 mg and 500 mg vials
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Zimrixby / Ituxredi by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
DRL_RIDr. Reddy's LaboratoriesMabTheraPhase 3Comparative efficacyCompletedApr 2020Jan 2022NCT04268771
DRL_RIDr. Reddy's LaboratoriesMabTheraPhase 3Comparative efficacyCompletedMay 2019Sep 2022NCT03976102

Other developers in the same markets

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

MarketRivalsDevelopers (product)
FDA3Amgen (Riabni), Celltrion (Truxima / Blitzima), Pfizer (Ruxience)
EMA3Celltrion (Truxima / Blitzima), Pfizer (Ruxience), Sandoz (Rixathon / Riximyo)
MHRA3Celltrion (Truxima / Blitzima), Pfizer (Ruxience), Sandoz (Rixathon / Riximyo)

Same developer, other molecules

Other biosimilars in the Atlas developed by Dr. Reddy's Laboratories: Dr. Reddy's bevacizumab, Dr. Reddy's darbepoetin alfa, Dr. Reddy's pegfilgrastim, Dr. Reddy's trastuzumab, Teriparatide Dr. Reddy's.

Chronology

Sources

All rituximab biosimilars

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Data current to September 2026.