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
FDAnot listed
EMAJun 2017authorised
CDSCOnot listed
EDEMar 2019registered
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Rixathon
European Medicines Agency and European CommissionApprovedBrand
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
European Union · Riximyo
European Medicines Agency and European CommissionApprovedBrand
Riximyo
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Jun 2017
Application or permission
EMEA/H/C/004729
Presentations
see SmPC
Note
Duplicate authorisation of Rixathon.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Rixathon
Emirates Drug EstablishmentRegisteredBrand
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
Chronology
- EMAJun 2017Authorised by the European Commission as Rixathon
- EMAJun 2017Authorised by the European Commission as Riximyo
- EDEMar 2019Registered in the UAE as Rixathon
Sources
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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