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Riabni FDA Approval History

Last updated by Judith Stewart, BPharm on June 8, 2022.

FDA Approved: Yes (First approved December 17, 2020)
Brand name: Riabni
Generic name: rituximab-arrx
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Rheumatoid Arthritis

Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

  • Riabni is indicated for the treatment of adult patients with:
    • Non-Hodgkin’s Lymphoma (NHL)
      • Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
      • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
      • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
      • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
    • Chronic Lymphocytic Leukemia (CLL)
      • Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
    • Rheumatoid Arthritis (RA)
      • In combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies.
    • Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
      • In combination with glucocorticoids.
  • The product label for Riabni contains a Boxed Warning to alert health care professionals and patients about the increased risk of fatal infusion reactions, severe skin and mouth reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.
  • The FDA approval of Riabni is based on clinical data that demonstrates Riabni is biosimilar to Rituxan.
  • Riabni is administered as an intravenous infusion by a healthcare professional with appropriate medical support to manage severe infusion reactions that may occur.
  • Most common adverse reactions in clinical trials were:
    • NHL (≥25%): infusion-related reactions, fever, lymphopenia, chills, infection and asthenia.
    • CLL (≥25%): infusion-related reactions and neutropenia.
    • RA (≥10%): upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events).
    • GPA and MPA (≥15%): infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema (other important adverse reactions include infusion-related reactions).
  • Riabni (rituximab-arrx) is the third FDA-approved rituximab biosimilar, following the approval of Ruxience (rituximab-pvvr) in July 2019 and Truxima (rituximab-abbs) in November 2018.

Development timeline for Riabni

Jun  7, 2022Approval FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan (rituximab), for Adults with Moderate to Severe Rheumatoid Arthritis
Dec 17, 2020Approval FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan
Aug 22, 2019Amgen And Allergan Announce Positive Top-Line Results From Comparative Clinical Study Of ABP 798, Biosimilar Candidate To Rituxan (Rituximab)
Jan 24, 2019Amgen And Allergan Announce Positive Top-Line Results From Phase 1/ Phase 3 Study Of ABP 798, Biosimilar Candidate To Rituximab

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.