RUXIENCE™ biosimilar granted approval from FDA

The US Food and Drug Administration (FDA) has approved RUXIENCE (rituximab-pvvr), a biosimilar to Rituxan (rituximab). The drug is for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

The medicine, produced by Pfizer, is a monoclonal antibody (mAb) biosimilar which works by targeting a protein called CD20, present on the surface of B cells. When it attaches to CD20, rituximab helps destroy the B cells.

The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of RUXIENCE to the reference product. The trial found no clinically meaningful differences in safety or efficacy compared to the reference drug.

“Rituximab became one of the first mAb cancer treatments when it was initially approved by the FDA, representing a significant treatment advance and the only option available to oncologists and their patients for a period of time,” said Dr Jeff Sharman, Medical Director, US Oncology Hematology Research.

RUXIENCE is Pfizer’s third oncology mAb biosimilar to be approved by the FDA this year. It has also been filed for regulatory approval with the European Medicines Agency (EMA) and is under review.

“Biosimilars like RUXIENCE have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care,” said Andy Schmeltz, Global President, Pfizer Oncology.