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NOVEMBER 29, 2018

FDA Approves Truxima, First Biosimilar to Rituxan

By Tom Rosenthal
The FDA approved rituximab-abbs (Truxima, Celltrion/Teva Pharmaceutical Industries) as the first biosimilar to rituximab (Rituxan, Biogen/Genentech) to treat adults with CD20-positive B-cell non-Hodgkin lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

The agency said rituximab-abbs was approved as a biosimilar, not as an interchangeable product.