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 · Company profile
FDAJul 2019approved
EMAApr 2020authorised
MHRALicenseddate not shown
PMDASep 2019approved
HCMay 2020approved
CDSCONot listed
EDEFeb 2021registered
Approved or registered in 6 of 7 markets
Connections
About Ruxience
Ruxience is Pfizer's rituximab, approved in the United States in 2019, in Japan the same year, in Europe and Canada in 2020, and registered in the UAE in 2021. With Trazimera and Zirabev it completes Pfizer's set of three cancer antibody biosimilars.
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
Reference product in the Purple Book
Rituxan
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 mg/10 mL, 500 mg/50 mL
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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 (EMA) · checked Sep 2026
MHRA
United Kingdom · Ruxience
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Ruxience
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 [Pfizer]
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Rituximab BS [Pfizer]
Holder or applicant
Pfizer Japan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2019
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 2.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Ruxience
Health CanadaApprovedBrand
Ruxience
Holder or applicant
Pfizer Canada ULC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
May 2020
Application or permission
DIN 02495724
Presentations
10 mg
Source
S022 (Health Canada) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Ruxience holds an approval, these are the other rituximab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 3 | Amgen (Riabni), Celltrion (Truxima / Blitzima), Dr. Reddy's Laboratories (Zimrixby / Ituxredi) |
| EMA | 3 | Celltrion (Truxima / Blitzima), Dr. Reddy's Laboratories (Zimrixby / Ituxredi), Sandoz (Rixathon / Riximyo) |
| MHRA | 3 | Celltrion (Truxima / Blitzima), Dr. Reddy's Laboratories (Zimrixby / Ituxredi), Sandoz (Rixathon / Riximyo) |
| PMDA | 1 | Sandoz (Rixathon / Riximyo) |
| HC | 2 | Celltrion (Truxima / Blitzima), Sandoz (Rixathon / Riximyo) |
| EDE | 2 | Celltrion (Truxima / Blitzima), Sandoz (Rixathon / Riximyo) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Pfizer: Abrilada / Amsparity, Ixifi / Zessly, Nivestym / Nivestim, Nyvepria, Trazimera, Zirabev.
Chronology
- FDAJul 2019Approved by FDA as Ruxience
- PMDASep 2019Approved by MHLW as Rituximab BS [Pfizer]
- EMAApr 2020Authorised by the European Commission as Ruxience
- HCMay 2020Notice of Compliance, Health Canada 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)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)
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