First Rituximab Biosimilar Truxima Gets FDA Approval
The Food and Drug Administration (FDA) has approved Truxima (rituximab-abbs; Celltrion and Teva), the first biosimilar to Rituxan (rituximab; Genentech), for the treatment of adults with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as monotherapy or in combination with chemotherapy.
Specifically, Truxima is indicated for:
- 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
The FDA approval was supported by clinical data describing structural and functional characterization, preclinical data, human pharmacokinetic data, clinical immunogenicity data, and other data which showed no clinically meaningful differences between Truxima and Rituxan; the products, however, are not interchangeable.
The most common adverse reactions associated with Truxima were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. Truxima carries a Boxed Warning regarding risks of fatal infusion reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy (PML).
Truxima will be available as a preservative-free solution for intravenous (IV) infusion as 100mg/10mL or 500mg/50mL single-dose vials.
For or more information call (888) 483-8279 or visit Truxima.com.