U.S. Food and Drug Administration Approves Biosimilar Rituximab-pvvr (Ruxience) for CD20-positive non-Hodgkin B-cell Lymphomas and Chronic Lymphocytic Leukemia

On July 23, 2019, the U.S. Food and Drug Administration (FDA) announced it has approved the use of rituximab-pvvr (Ruxience, Pfizer), a biosimilar to rituximab (Rituxan, Genentech, Biogen) for the treatment of CD20-positive non-Hodgkin B-cell Lymphoma (NHL) and chronic lymphocytic leukemia (CLL).  This is the second biosimilar to rituximab approved for the treatment of lymphoma.

Indications for rituximab-pvvr include:

  • Relapsed/refractory, low grade or follicular lymphoma (FL), CD20-positive B-cell NHL as a single agent;
  • Previously untreated FL, 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 a single-agent maintenance therapy;
  • Non-progressing, low-grade, CD20-positive, B-cell NHL as a single agent first line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy;
  • Previously untreated diffuse large B-cell lymphoma (DLBCL) 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 (FC).

The U.S. Congress, through the Biologics Price Competition and Innovation Act of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. These standards may be viewed on the FDA website.

“The approval of rituximab-pvvr represents a new treatment option for people with non-Hodgkin lymphoma and chronic lymphocytic leukemia,” said Meghan Gutierrez, Chief Executive Officer at the Lymphoma Research Foundation. “Additional biologic and novel therapies are important to ensuring that patients and their physicians, through shared decision making, are able to access the right treatments at the right time.”

For more information on the FDA approval of rituximab-pvvr (Ruxience), visit the FDA’s website.