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Truxima / Blitzima

Rituximab biosimilar developed by Celltrion, development code CT-P10. Reference product MabThera (Rituxan in the United States).

Brands by market: Truxima (USA, EU, UAE); Blitzima (EU); Ritemvia and Rituzena (EU, withdrawn) · Commercial partner or holder: Celltrion; Hikma (UAE)

FDANov 2018approved

EMAFeb 2017authorised

CDSCOnot listed

EDEApr 2020registered

Status by market

FDA

United States · Truxima

US Food and Drug AdministrationApproved

Brand

Truxima

Holder or applicant

CELLTRION, Inc.

Pathway

351(k)

Approved

Nov 2018

Application or permission

761088

Licence type

351(k) interchangeable, designated Jun 2026

Presentations

100 mg/10 mL, 500 mg/50 mL

Note

First FDA-approved rituximab biosimilar.

Source

S001, S016

EMA

European Union · Truxima

European Medicines Agency and European CommissionApproved

Brand

Truxima

Holder or applicant

Celltrion Healthcare Hungary Kft.

Pathway

Centralised (Article 10(4))

Approved

Feb 2017

Application or permission

EMEA/H/C/004112

Indications as licensed

NHL, CLL, RA, GPA and MPA

Presentations

see SmPC

Note

First EU rituximab biosimilar.

Source

S017

EMA

European Union · Blitzima

European Medicines Agency and European CommissionApproved

Brand

Blitzima

Holder or applicant

Celltrion Healthcare Hungary Kft.

Pathway

Centralised (Article 10(4))

Approved

Jul 2017

Application or permission

EMEA/H/C/004723

Presentations

see SmPC

Note

Duplicate authorisation, oncology indications.

Source

S017

EMA

European Union · Ritemvia

European Medicines Agency and European CommissionWithdrawn

Brand

Ritemvia

Holder or applicant

Celltrion Healthcare Hungary Kft.

Pathway

Centralised (Article 10(4))

Approved

Jul 2017

Application or permission

EMEA/H/C/004725

Withdrawn

date not published

Presentations

see SmPC

Note

Duplicate authorisation; withdrawal date not published in the EMA table.

Source

S017

EMA

European Union · Rituzena

European Medicines Agency and European CommissionWithdrawn

Brand

Rituzena

Holder or applicant

Celltrion Healthcare Hungary Kft.

Pathway

Centralised (Article 10(4))

Approved

Jul 2017

Application or permission

EMEA/H/C/004724

Withdrawn

Apr 2019

Presentations

see SmPC

Note

Duplicate authorisation, previously Tuxella.

Source

S017

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Truxima

Emirates Drug EstablishmentRegistered

Brand

Truxima

Holder or applicant

Hikma Pharmaceuticals, Jordan (for Celltrion) · UAE supplier Alphamed Drug Store

Pathway

Registered medical product

Registered

Apr 2020

Presentations

100 mg/10 mL, 500 mg/50 mL

Source

S018

Chronology

EMAFeb 2017Authorised by the European Commission as Truxima
EMAJul 2017Authorised by the European Commission as Blitzima
FDANov 2018Approved by FDA as Truxima
EMAApr 2019Rituzena authorisation withdrawn
EDEApr 2020Registered in the UAE as Truxima
FDAJun 2026Truxima designated interchangeable

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)
S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)

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Data current to September 2026.