Posted from: Friday, August 09, 2019 - 03:17 PM - Present

Ruxience Approved as Rituxan Biosimilar

July 23, 2019 – The U.S. FDA has approved Pfizer’s Ruxience™ (rituximab-pvvr) as a biosimilar for Genentech’s Rituxan® (rituximab). It is indicated to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). Ruxience is the second biosimilar approved for Rituxan in the United States, and the 22nd overall biosimilar approved by the FDA.

In a clinical comparative study, Ruxience was found to have no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma. Recommended dosing is based on the indication. In some cases, Ruxience is indicated for use as a single therapy, while in others it is used in combination with an additional therapy such as chemotherapy or glucocorticoids.

A black box warning cautions that all rituximab products carry a risk of fatal infusion-related reactions, severe mucocutaneous (involving skin and mucous membranes) reactions, hepatitis B reactivation (in patients infected with the virus), and progressive multifocal leukoencephalopathy (a viral infection of the brain).

As a biosimilar, Ruxience is not automatically interchangeable with Rituxan, but may offer patients an alternative treatment at a lower list price. Pfizer has not yet announced launch or pricing plans for the product.

Last Updated Friday, October 18, 2019 - 12:34 AM.