FDA Approves Ruxience, Second Biosimilar Rituximab

July 23, 2019

Biosimilars Team

The Food and Drug Administration (FDA) has approved Ruxience (rituximab-pvvr; Pfizer), a biosimilar to rituximab (Rituxan; Biogen/Genentech). Both products are monoclonal antibodies that target the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes.

Ruxience is the second biosimilar rituximab. Truxima (rituximab-abbs; Celltrion) was approved in November 2018. Neither Ruxience nor Truxima is approved as an interchangeable product.

Ruxience is approved for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. Specifically, Ruxience is indicated for:

  • Relapsed or refractory, low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma as a single agent.
  • Previously untreated follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma 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.
  • Nonprogressing (including stable disease), low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
  • Previously untreated diffuse large B-cell, CD20-positive non-Hodgkin’s lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy.
  • Previously untreated and previously treated CD20-positive chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide (FC).
  • Granulomatosis with Polyangiitis (GPA; Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.

Like Rituxan, the labeling for Ruxience contains a Boxed Warning to alert health care professionals and patients about increased risks of the following: fatal infusion-related reactions; severe skin and mouth reactions, some with fatal outcomes; hepatitis B virus reactivation, that may cause serious liver problems including liver failure and death; and progressive multifocal leukoencephalopathy, a rare, serious brain infection that can result in severe disability or death. This product must be dispensed with a patient Medication Guide that provides important information about the drug’s uses and risks.