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News From the Food and Drug Administration
January 1/8, 2019

A First in Non-Hodgkin Lymphoma Treatment

JAMA. 2019;321(1):23. doi:10.1001/jama.2018.20501

The first biosimilar to rituximab for patients with non-Hodgkin lymphoma has received FDA approval. Rituximab-abbs is indicated for adults with CD20-positive, B-cell non-Hodgkin lymphoma. It can be used as a single agent or in combination with chemotherapy.

Biosimilars are biological products that are approved based on data showing that they’re highly similar to a biological product that already has received FDA approval. Biosimilars can have no clinically meaningful differences in safety and effectiveness, and they must meet other criteria specified by law.