August 5, 2026
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FDA approves rituximab biosimilar for B-cell malignancies

The United States Food and Drug Administration has approved a rituximab biosimilar candidate developed by pharmaceutical company Dr. Reddy’s Laboratories.

Rituximab is a monoclonal antibody that targets CD20 on B cells to treat adult B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia.

Under an exclusive commercialization agreement, the global healthcare company Fresenius Kabi holds rights to commercialize the drug in the United States. The product was developed, manufactured, and submitted for approval by Dr. Reddy’s Laboratories, according to a press release.

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