Home/Biosimilar Atlas/Rituximab/Rixathon / Riximyo

Rixathon / Riximyo

Rituximab biosimilar developed by Sandoz, development code GP2013. Reference product MabThera (Rituxan in the United States).

Brands by market: Rixathon (EU, UAE); Riximyo (EU) · Commercial partner or holder: Sandoz · Company profile

FDANot listed

EMAJun 2017authorised

MHRALicenseddate not shown

PMDASep 2017approved

HCApr 2020approved

CDSCONot listed

EDEMar 2019registered

Approved or registered in 5 of 7 markets

Connections

Rituximabmolecule Sandozdeveloper 5 of 7markets 2trials behind it 9other products, same developer 3rival developers in its markets

About Rixathon / Riximyo

Rixathon is Sandoz's rituximab, approved in Europe in 2017 under two names, Rixathon and Riximyo, and in Japan the same year, where it was the first rituximab biosimilar and was developed with Kyowa Kirin. It is registered in the UAE and approved in Canada as Riximyo. Sandoz has not filed it in the United States.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Rixathon

European Medicines Agency and European CommissionApproved

Brand

Rixathon

Holder or applicant

Sandoz GmbH

Pathway

Centralised (Article 10(4))

Approved

Jun 2017

Application or permission

EMEA/H/C/003903

Indications as licensed

NHL, CLL, RA, GPA and MPA

Presentations

see SmPC

Source

S017 (EMA) · checked Sep 2026

EMA

European Union · Riximyo

European Medicines Agency and European CommissionApproved

Brand

Riximyo

Holder or applicant

Sandoz GmbH

Pathway

Centralised (Article 10(4))

Approved

Jun 2017

Application or permission

EMEA/H/C/004729

Presentations

see SmPC

Remarks

Duplicate authorisation of Rixathon.

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Rixathon

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Rixathon

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 · Rituximab BS [KHK]

Pharmaceuticals and Medical Devices Agency and MHLWApproved

Brand

Rituximab BS [KHK]

Holder or applicant

Sandoz K.K. (co-developed with Kyowa Kirin)

Pathway

Biosimilar (MHLW approval on PMDA review)

Approved

Sep 2017

Indications as licensed

CD20-positive B-cell NHL, post-transplant lymphoproliferative disorder, GPA and MPA

Presentations

100 mg and 500 mg vials

Remarks

Rituximab Biosimilar 1, the first in Japan.

Source

S020 (PMDA) · checked Sep 2026

Canada · Riximyo

Health CanadaApproved

Brand

Riximyo

Holder or applicant

Sandoz Canada Incorporated

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Apr 2020

Application or permission

DIN 02498316

Presentations

10 mg

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Rixathon

Emirates Drug EstablishmentRegistered

Brand

Rixathon

Holder or applicant

Lek Pharmaceuticals d.d., Slovenia (Sandoz) · UAE supplier Alphamed Drug Store

Pathway

Registered medical product

Registered

Mar 2019

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 Rixathon / Riximyo 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
GP2013	Sandoz	MabThera	Phase 3	Comparative efficacy	Completed	Dec 2011	Jul 2015	NCT01419665
GP2013	Sandoz	MabThera	Phase 3	Comparative efficacy	Completed	Jul 2015	Jul 2016	NCT02514772

Other developers in the same markets

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

Market	Rivals	Developers (product)
EMA	3	Celltrion (Truxima / Blitzima), Dr. Reddy's Laboratories (Zimrixby / Ituxredi), Pfizer (Ruxience)
MHRA	3	Celltrion (Truxima / Blitzima), Dr. Reddy's Laboratories (Zimrixby / Ituxredi), Pfizer (Ruxience)
PMDA	1	Pfizer (Ruxience)
HC	2	Celltrion (Truxima / Blitzima), Pfizer (Ruxience)
EDE	2	Celltrion (Truxima / Blitzima), Pfizer (Ruxience)

Same developer, other molecules

Other biosimilars in the Atlas developed by Sandoz: Binocrit / Epoetin alfa Hexal / Abseamed, Enzeevu / Afqlir, Erelzi, Hyrimoz / Hefiya, Inclunox, Jubbonti / Wyost, Omnitrope, Zarxio / Zarzio, Ziextenzo.

Chronology

EMAJun 2017Authorised by the European Commission as Rixathon
EMAJun 2017Authorised by the European Commission as Riximyo
PMDASep 2017Approved by MHLW as Rituximab BS [KHK]
EDEMar 2019Registered in the UAE as Rixathon
HCApr 2020Notice of Compliance, Health Canada as Riximyo

Sources

S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) 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.