Truxima First Biosimilar to Rituxan FDA-Approved for Non-Hodgkin Lymphoma

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates


On November 28, 2018, the FDA approved rituximab-abbs (Truxima; Celltrion) as the first biosimilar to rituximab (Rituxan; Genentech) for patients with CD20-positive, B-cell non-Hodg­kin lymphoma (NHL), for use as a single agent or in combination with chemotherapy.

Truxima is indicated for the treatment of adults with relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL as a single agent; untreated follicular, CD20-positive, B-cell NHL, in combination with first-line chemotherapy, and, in patients achieving a complete or partial response to rituximab therapy plus chemotherapy, as single-­agent maintenance therapy; and for nonprogressing (including stable disease), low-grade, CD20-positive B-cell NHL, as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

The approval was based on extensive data demonstrating that Truxima is biosimilar to Rituxan.

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