Riabni

Rituximab biosimilar developed by Amgen, development code ABP 798. Reference product MabThera (Rituxan in the United States).

Brands by market: Riabni (USA) · Commercial partner or holder: Amgen · Company profile
FDADec 2020approved
EMANot listed
MHRANot listed
PMDANot listed
HCWithdrawn
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Riabni

Riabni is Amgen's rituximab, approved in the United States in December 2020. Its Canadian approval was cancelled after marketing. Amgen has not filed it in Europe.

Status by market

FDA

United States · Riabni

US Food and Drug AdministrationApproved
Brand
Riabni
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Dec 2020
Application or permission
761140
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

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada · Riabni

Health CanadaWithdrawn
Brand
Riabni
Holder or applicant
Amgen Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Mar 2021
Application or permission
DIN 02513447
Withdrawn
date not published
Presentations
10 mg
Remarks
Cancelled post-market in the Drug Product Database.
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
FDA3Celltrion (Truxima / Blitzima), Dr. Reddy's Laboratories (Zimrixby / Ituxredi), Pfizer (Ruxience)

Same developer, other molecules

Other biosimilars in the Atlas developed by Amgen: Amjevita / Amgevita, Avsola, Bkemv / Bekemv, Kanjinti, Mvasi, Pavblu, Wezlana / Wezenla.

Chronology

Sources

All rituximab biosimilars

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Data current to September 2026.