RxBNRituxan
rituximab
1 reference · 1 interchangeable · 3 biosimilar-only
Reference Product
Rituxan
rituximab
351(a) Reference Product (Approval Date 26-Nov-1997)
ApplicantGenentech, Inc.
BLA103705
RouteIntravenous
Presentation
Single-Dose Vial
Rituxan
rituximab
351(a) Reference Product (Approval Date 26-Nov-1997)
ApplicantGenentech, Inc.
BLA103705
·RouteIntravenous
Presentation
Single-Dose Vial
Interchangeable Biosimilars
Truxima
rituximab-abbs
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Jun-2026)
ApplicantCELLTRION, Inc.
BLA761088
RouteIntravenous
Presentation
Single-Dose Vial
Truxima
rituximab-abbs
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Jun-2026)
ApplicantCELLTRION, Inc.
BLA761088
·RouteIntravenous
Presentation
Single-Dose Vial
Biosimilars (not interchangeable)
Riabni
rituximab-arrx
351(k) Biosimilar (Approval Date 17-Dec-2020)
ApplicantAmgen Inc.
BLA761140
RouteIntravenous
Presentation
Single-Dose Vial
Riabni
rituximab-arrx
351(k) Biosimilar (Approval Date 17-Dec-2020)
ApplicantAmgen Inc.
BLA761140
·RouteIntravenous
Presentation
Single-Dose Vial
Ruxience
rituximab-pvvr
351(k) Biosimilar (Approval Date 23-Jul-2019)
ApplicantPfizer Ireland Pharmaceuticals Unlimited Company
BLA761103
RouteIntravenous
Presentation
Single-Dose Vial
Ruxience
rituximab-pvvr
351(k) Biosimilar (Approval Date 23-Jul-2019)
ApplicantPfizer Ireland Pharmaceuticals Unlimited Company
BLA761103
·RouteIntravenous
Presentation
Single-Dose Vial
Zimrixby
rituximab-cdxx
351(k) Biosimilar (Approval Date 31-Jul-2026)
ApplicantDr. Reddy's Laboratories SA
BLA761376
RouteIntravenous
Presentation
Single-Dose Vial
Zimrixby
rituximab-cdxx
351(k) Biosimilar (Approval Date 31-Jul-2026)
ApplicantDr. Reddy's Laboratories SA
BLA761376
·RouteIntravenous
Presentation
Single-Dose Vial