FDA Approves Truxima as Biosimilar to Rituxan for Non-Hodgkin’s Lymphoma

It should be used as a single agent or in combination with chemotherapy

On 28 November 2018, the US Food and Drug Administration (FDA) approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

Truxima is indicated for the treatment of adult patients with:

  • 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; and
  • 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.

Healthcare professionals should review the prescribing information in the labelling for detailed information about the approved uses.

Full prescribing information for Truxima is available here.

The approval was based on comparisons of extensive structural and functional product characterisation, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity, and other clinical safety and effectiveness data demonstrating that Truxima is biosimilar to US Rituxan. Truxima has been approved as a biosimilar, not as an interchangeable product.

The most common side effects of Truxima are infusion reactions, fever, lymphopenia, chills, infection, and asthenia.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.