FDA Approves Rituxan Biosimilar to Treat Blood Cancers

The Food and Drug Administration (FDA) approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with specific types of non-Hodgkin’s lymphoma (NHL) and those with chronic lymphocytic leukemia (CLL).

The biosimilar’s indications include treatment for:

• 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 Rituxan 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 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; and
• Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide.

This is the second biosimilar for Rituxan to be approved in the United States, and the 22nd biosimilar product to be approved by the FDA.

Biosimilar approvals are contingent on the fact that they are highly similar to a reference product, or a product that has already been approved by the FDA. These drugs must also be shown to have no clinically meaningful differences in safety or efficacy from the reference product.

Check back later for more information on what this approval means for patients.