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
FDAJul 2026approved
EMASep 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Zimrixby
US Food and Drug AdministrationApprovedBrand
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
Presentations
100 mg/10 mL, 500 mg/50 mL
Source
S001, S016
EMA
European Union · Ituxredi
European Medicines Agency and European CommissionApprovedBrand
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMASep 2024Authorised by the European Commission as Ituxredi
- FDAJul 2026Approved by FDA as Zimrixby
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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