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Ruxience FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Jul 23, 2019.

FDA Approved: Yes (First approved July 23, 2019)
Brand name: Ruxience
Generic name: rituximab-pvvr
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, Microscopic polyangiitis

Ruxience (rituximab-pvvr) 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 Ruxience 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 Ruxience is based on clinical data that demonstrates Ruxience is biosimilar to Rituxan.
  • Ruxience 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).
  • Ruxience (rituximab-pvvr) is the second FDA-approved rituximab biosimilar, following the approval of Truxima (rituximab-abbs) in November 2018.

Development Timeline for Ruxience

Jul 23, 2019Approval FDA Approves Ruxience (rituximab-pvvr), a Biosimilar to Rituxan

Further information

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