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
FDADec 2020approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Riabni
US Food and Drug AdministrationApprovedBrand
Riabni
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Dec 2020
Application or permission
761140
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg/10 mL, 500 mg/50 mL
Source
S001, S016
EMA
European Union
Not listed by EMA.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDADec 2020Approved by FDA
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
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