What is the difference between Truxima and Rituxan?

Truxima (rituximab-abbs) is a biosimilar to Rituxan (rituximab). Truxima is indicated for the treatment of non-Hodgkin’s lymphoma, while Rituxan is indicated for the expanded treatment of non-Hodgkin’s lymphoma, plus several other medical conditions.

Biosimilars are highly similar to an already-approved biological product with no known differences in safety and effectiveness. The FDA-approved indications and usages differ between Rituxan and Truxima.

Truxima and Rituxan belong to the class of drugs called CD20-directed cytolytic antibodies.

Truxima is approved for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL):

• 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.

Rituxan is indicated for the expanded treatment of non-Hodgkin’s lymphoma, plus several other medical conditions in adults patients, including:

• 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 Rituxan 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 inpatients two years of age and older.
• Pemphigus Vulgaris (PV):
  • Moderate to severe disease in adult patients.

For more information, see What Are Biosimilars? Top Facts You May Not Know