Riabni FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 2, 2021.
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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.