The Food and Drug Administration approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), for the treatment of certain adult patients with CD20-positive B-cell non-Hodgkin’s lymphoma and those with chronic lymphocytic leukemia.
The Food and Drug Administration (FDA) approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with specific types of non-Hodgkin’s lymphoma (NHL) and those with chronic lymphocytic leukemia (CLL).
The biosimilar’s indications include treatment for:
This is the second biosimilar for Rituxan to be approved in the United States, and the 22nd biosimilar product to be approved by the FDA.
Biosimilar approvals are contingent on the fact that they are highly similar to a reference product, or a product that has already been approved by the FDA. These drugs must also be shown to have no clinically meaningful differences in safety or efficacy from the reference product.