FDA Approves First Biosimilar for Non-Hodgkin Lymphoma

The US Food and Drug Administration (FDA) has approved the first biosimilar drug to treat adults with some types of non-Hodgkin lymphoma. Truxima (rituximab-abbs) is a biosimilar to Rituxan (rituximab), a type of immunotherapy drug called a monoclonal antibody.

A biosimilar is a product that has been shown to very similar to a biological product that has already been approved. Biosimilars are approved when studies show there are no important differences in how well they work and how safe they are. They can potentially be less expensive than the original version.

In this case, Truxima works the same way as Rituxan. For patients with CD20-positive, B-cell non-Hodgkin lymphoma, Truxima targets the CD20 antigen, a substance on the surface of B lymphocytes (including B-cell lymphoma cells). It can be used along with chemotherapy or on its own, depending on the individual cancer diagnosis.

“The Truxima approval is our third biosimilar approval in the past month,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures. We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval.”

The FDA based its approval of Truxima on scientific data that show its safety and effectiveness is similar to Rituxan’s. But the FDA notes that it has approved Truxima as a biosimilar, and not as a product that is interchangeable with Rituxan.  Health care providers should review prescribing information for detailed information about the approved uses.

Side effects of Truxima are expected to be similar to those of Rituxan. The most common side effects include infusion reactions, fever, chills, infection, low white blood cell counts, and weakness. People taking Truxima should also be monitored for tumor lysis syndrome (a treatment complication that can occur when tumor cells are killed off quickly and their content is released into the blood), heart or kidney problems, and bowel obstruction. Patients should not get vaccinations while taking Truxima. Women who are pregnant or breastfeeding should not take Truxima.

Like Rituxan, Truxima contains a boxed warning to alert providers and patients to the most serious side effects.

Truxima is marketed by Celltrion. Rituxan is marketed by Genentech.

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