FDA Approves Rituximab-ABBS as Biosimilar to Rituximab for Non-Hodgkin Lymphoma
On November 28, 2018, the U.S. Food and Drug Administration (FDA) approved rituximab-abbs (Truxima) as the first biosimilar to rituximab (Rituxan) for patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.
Rrituximab-abbs is indicated for the treatment of adult patients with the following:
- 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.
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.
Healthcare professionals should review the prescribing information in the labeling for detailed information about the approved uses. View full prescribing information for rituximab-abbs (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf).
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 rituximab-abbs is biosimilar to rituximab. Rituximab-abbs has been approved as a biosimilar (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm), not as an interchangeable product (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm).
The most common side effects of rituximab-abbs 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 (http://www.fda.gov/medwatch/report.htm) or by calling 1-800-FDA-1088.
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