Ruxience
Rituximab biosimilar developed by Pfizer, development code PF-05280586. Reference product MabThera (Rituxan in the United States).
Brands by market: Ruxience (USA, EU, UAE) · Commercial partner or holder: Pfizer
FDAJul 2019approved
EMAApr 2020authorised
CDSCOnot listed
EDEFeb 2021registered
Status by market
FDA
United States · Ruxience
US Food and Drug AdministrationApprovedBrand
Ruxience
Holder or applicant
Pfizer Ireland Pharmaceuticals Unlimited Company
Pathway
351(k)
Approved
Jul 2019
Application or permission
761103
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg/10 mL, 500 mg/50 mL
Source
S001, S016
EMA
European Union · Ruxience
European Medicines Agency and European CommissionApprovedBrand
Ruxience
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Apr 2020
Application or permission
EMEA/H/C/004696
Indications as licensed
NHL, CLL, RA, GPA and MPA
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Ruxience
Emirates Drug EstablishmentRegisteredBrand
Ruxience
Holder or applicant
Pfizer Manufacturing Belgium NV · UAE supplier Modern Pharmaceutical Company
Pathway
Registered medical product
Registered
Feb 2021
Presentations
100 mg/10 mL, 500 mg/50 mL
Source
S018
Chronology
- FDAJul 2019Approved by FDA as Ruxience
- EMAApr 2020Authorised by the European Commission as Ruxience
- EDEFeb 2021Registered in the UAE as Ruxience
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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