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Riabni FDA Approval History

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

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), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

  • 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.
    • 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

DateArticle
Dec 17, 2020ApprovalFDA 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

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