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Brands by market: Truxima (USA, EU, UAE); Blitzima (EU); Ritemvia and Rituzena (EU, withdrawn) · Commercial partner or holder: Celltrion; Hikma (UAE) · Company profile

FDANov 2018approved

EMAFeb 2017authorised

MHRALicenseddate not shown

PMDANot listed

HCApr 2019approved

CDSCONot listed

EDEApr 2020registered

Approved or registered in 5 of 7 markets

Connections

Rituximabmolecule Celltriondeveloper 5 of 7markets 1trial behind it 9other products, same developer 4rival developers in its markets

About Truxima / Blitzima

Truxima is Celltrion's rituximab, the first rituximab biosimilar approved in Europe, in February 2017, and the first in the United States, in November 2018. In 2026 it became the only rituximab biosimilar designated interchangeable in the United States. Celltrion also holds a second European name, Blitzima, for cancer uses, and withdrew two others. It is registered in the UAE through Hikma and approved in Canada.

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

Reference product in the Purple Book

Rituxan

Marketing status (Purple Book)

Prescription, marketed

Presentations

100 mg/10 mL, 500 mg/50 mL

Remarks

First FDA-approved rituximab biosimilar.

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

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

Remarks

First EU rituximab biosimilar.

Source

S017 (EMA) · checked Sep 2026

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

Remarks

Duplicate authorisation, oncology indications.

Source

S017 (EMA) · checked Sep 2026

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

Remarks

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

Source

S017 (EMA) · checked Sep 2026

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

Remarks

Duplicate authorisation, previously Tuxella.

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Truxima

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Truxima

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.

Canada · Truxima

Health CanadaApproved

Brand

Truxima

Holder or applicant

Celltrion INC.

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Apr 2019

Application or permission

DIN 02478382, 02478390

Presentations

100, 500 mg

Source

S022 (Health Canada) · checked Sep 2026

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 (UAE Emirates Drug Establishment) · checked Sep 2026

Trials behind this product

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

Candidate	Developer or sponsor	Reference product	Phase	Design	Registry status	Started	Primary completion	Registry record
CT-P10	Celltrion	MabThera	Phase 1	Comparative PK	Completed	Feb 2012	Aug 2013	NCT01534884

Other developers in the same markets

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

Market	Rivals	Developers (product)
FDA	3	Amgen (Riabni), Dr. Reddy's Laboratories (Zimrixby / Ituxredi), Pfizer (Ruxience)
EMA	3	Dr. Reddy's Laboratories (Zimrixby / Ituxredi), Pfizer (Ruxience), Sandoz (Rixathon / Riximyo)
MHRA	3	Dr. Reddy's Laboratories (Zimrixby / Ituxredi), Pfizer (Ruxience), Sandoz (Rixathon / Riximyo)
HC	2	Pfizer (Ruxience), Sandoz (Rixathon / Riximyo)
EDE	2	Pfizer (Ruxience), Sandoz (Rixathon / Riximyo)

Same developer, other molecules

Other biosimilars in the Atlas developed by Celltrion: Avtozma, Eydenzelt, Herzuma, Omlyclo, Remsima / Inflectra, Steqeyma, Stoboclo / Osenvelt, Vegzelma, Yuflyma.

Chronology

EMAFeb 2017Authorised by the European Commission as Truxima
EMAJul 2017Authorised by the European Commission as Blitzima
FDANov 2018Approved by FDA as Truxima
HCApr 2019Notice of Compliance, Health Canada 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)
S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All rituximab biosimilars

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Data current to September 2026.