Ruxience FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 31, 2026.

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, Rheumatoid Arthritis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Pemphigus Vulgaris

Ruxience (rituximab-pvvr) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

• Ruxience is indicated for the treatment of:
  Non-Hodgkin’s Lymphoma (NHL)
  • 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)
  • Adult patients with Chronic Lymphocytic Leukemia (CLL).
  - Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
  Rheumatoid Arthritis (RA)
  • 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)
  • Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.
  Pemphigus Vulgaris
  • Moderate to severe Pemphigus Vulgaris (PV) in adult patients.
• Ruxience is approved in the following presentations:
  

  Product Presentation	Strength	Biosimilar / Interchangeable
  Single-Dose Vial (Intravenous Injection)	100 mg / 10 mL (10 mg / mL)	Biosimilar
  Single-Dose Vial (Intravenous Injection)	500 mg / 50 mL (10 mg / mL)	Biosimilar

• FDA approval of Ruxience was based on clinical data that demonstrated 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.
• 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. Warnings and precautions include tumor lysis syndrome, infections, cardiac adverse reactions, renal toxicity, bowel obstruction and perforation, and embryo-fetal toxicity.
• Common adverse reactions in clinical trials in:
  • NHL (greater than or equal to 25%) include infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia.
  • CLL (greater than or equal to 25%) include infusion-related reactions and neutropenia.
  • RA (greater than or equal to 10%) include 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 (greater than or equal to 15 %) include infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, infusion-related reactions.
  • PV (greater than or equal to 15%) include infusion-related reactions, depression, upper respiratory tract infection/nasopharyngitis, headache (other important adverse reactions include infections).
• Ruxience (rituximab-pvvr) is the second FDA-approved biosimilar to Rituxan.

Rituxan Biosimilars

Development timeline for Ruxience

Further information

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

Medical Disclaimer