FDA Approves Truxima, First Biosimilar Rituximab

November 28, 2018

Biosimilars Team

The Food and Drug Administration (FDA) has approved Truxima (rituximab-abbs; Celltrion), the first biosimilar rituximab (Rituxan; Biogen/Genentech). Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes.

Truxima is indicated for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma. It is the first biosimilar approved in the United States for the treatment of non-Hodgkin’s lymphoma.

Specifically, Truxima is indicated for the treatment of adult patients with:

  • 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.
  • Non-progressing (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.

Truxima is not approved as an interchangeable product.

Like Rituxan, the labeling for Truxima contains a Boxed Warning to alert health care professionals and patients about increased risks of the following: fatal infusion 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.