Behind Riabni™ A Robust Biosimilars Program

RIABNI™ IS A PROVEN BIOSIMILAR TO RITUXAN®

Based on a comprehensive totality of evidence, RIABNI™ demonstrates biosimilarity to Rituxan® with no clinically meaningful differences in safety and efficacy.1

Table name here
BIOSIMILAR DEVELOPMENT STEPS FDA requirements for biosimilar approval2 RIABNI™1,3,4
Analytical comparison
Nonclinical studies
Clinical pharmacology
Comparative clinical study(homogeneous low-grade FL population)
  • FL = follicular lymphoma.

RIABNI™ is FDA approved for all Rituxan® oncology indications4,5,*

  • *RIABNI™ is also indicated for the treatment of Granulomatosis with Polyangiitis (GPA) (Wegener's granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients.

Approval is based on the totality of evidence that includes ≥ 1 confirmatory clinical study.6

I was actually very excited [about Amgen Biosimilars] because Amgen has a very long experience in manufacturing biologics.

– Dr Lee Schwartzberg, Oncologist
logo-amgen-biosim
Interested in learning more about the scientific justification for extrapolation?

RIABNI™ efficacy proven similar to Rituxan® with no clinically meaningful differences

JASMINE: Randomized, double-blind international study that demonstrated clinical similarity of RIABNI™ to Rituxan® (6 infusions of 375 mg/m2 at weeks 1-4, 12, 20) in patients* with CD20-positive previously-untreated follicular lymphoma (FL).1,3,7

OVERALL RESPONSE RATE (ORR) RIABNI™ VS RITUXAN® (primary endpoint)1,3

Overall response rate of RIABNI™ vs. Rituxan®
Overall response rate of RIABNI™ vs. Rituxan®
  • ORR = complete response + unconfirmed complete response + partial response.
  • Secondary endpoints: RD of ORR at week 12, percentage of patients with complete depletion of CD19 cell count and total levels of IgE and IgM (baseline to day 8), immunogenicity of RIABNI™ vs Rituxan®, progression-free survival (PFS) and overall survival (OS).1,3,7

At the end of the study, all patients were alive and median PFS was not reached (both treatment arms)3

  • *Patients (N = 250) with confirmed B-cell FL grade 1, 2, or 3a; low tumor burden, ≥ 18 years of age were enrolled from 150 sites in Europe, North America, Latin America, and Asia Pacific.1,3
  • †Central review.

    CI = confidence interval; IgE = Immunoglobulin E; IgM = Immunoglobulin M.

RIABNI™ has a benefit/risk profile that is consistent with Rituxan® with no clinically meaningful differences in treatment-emergent adverse events (TEAEs) and serious adverse events (AEs).1

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  RIABNI™
(N = 128)
n (%)
Rituxan®
(N = 126)
n (%)
Most common TEAEs (≥ 5%)    
Abdominal pain 4 (3.1) 10 (7.9)
Asthenia 12 (9.4) 6 (4.8)
Diarrhea 3 (2.3) 9 (7.1)
Fatigue 13 (10.2) 12 (9.5)
Headache 15 (11.7) 12 (9.5)
Nausea 6 (4.7) 14 (11.1)
Pruritus 6 (4.7) 12 (9.5)
Pyrexia 8 (6.3) 8 (6.3)
Rash 9 (7.0) 6 (4.8)
Throat irritation 9 (7.0) 8 (6.3)
Upper respiratory tract infection 7 (5.5) 1 (0.8)
Urticaria 7 (5.5) 2 (1.6)
Grade ≥ 3 AE 14 (10.9) 13 (10.3)
Any events of interestAny AE of interest 63 (49.2) 57 (45.2)
Infusion reactions including hypersensitivity* 55 (43.0) 54 (42.9)
Hematological reactions 7 (5.5) 6 (4.8)
Cardiac disorders 3 (2.3) 2 (1.6)
Serious infections 2 (1.6) 0 (0.0)
Severe mucocutaneous reactions 1 (0.8) 0 (0.0)
  • No patients experienced gastrointestinal perforation, hepatitis B reactivation, opportunistic infection, progressive multifocal leukoencephalopathy, reversible posterior leukoencephalopathy syndrome, or tumor lysis syndrome.
  • *Infusion reactions including hypersensitivity adverse events of interest must have start date the same as, or 1 day after, an intraperitoneal product administration start date.

The incidence of developing anti-drug antibodies (ADAs) was consistent across the treatment groups (< 2.5% in either group) and the majority were transient1

See how RIABNI™ and Rituxan® have identical dosing and administration