FDA Approves Rituximab-ABBS as Biosimilar to Rituximab for Non-Hodgkin Lymphoma

November 28, 2018
FDA Approves Rituximab-ABBS as Biosimilar to Rituximab for Non-Hodgkin’s 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:

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.

In collaboration with the FDA and as a service to our members, ONS provides updates on recent FDA approvals and other important FDA actions (e.g., updated safety information, new prescribing information) pertaining to therapies for patients with cancer. This allows the agency to inform oncologists and professionals in oncology-related fields in a timely manner. Included in the FDA updates is a link to the product label or to other sites for additional relevant clinical information. In supplying this information, ONS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

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