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

Further information

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