November 28, 2018
On November 28, 2018, the Food and Drug Administration 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, CD20positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
The approval was based on comparisons of extensive structural and functional product characterization, 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 by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).