Pfizer’s Rituxan biosimilar bags FDA approval

The US Food and Drug Administration (FDA) has approved Pfizer’s Ruxience (rituximab-pvvr), a biosimilar to Roche’s Rituxan (rituximab).

The treatment has been approved in adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

The approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of Ruxience to Rituxan, including results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of the biosimilar and found no clinically meaningful differences in safety or efficacy in patients with CD20-positive, low tumour burden follicular lymphoma.

“Rituximab became one of the first monoclonal antibody (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 Haematology Research. “With this FDA approval, clinicians have an additional treatment option that will help improve access to care for patients in need of anti-CD20 mAb therapy.”

Both Rituxan and its biosimilar work by targeting a protein called CD20, which is present on the surface of B cells. When it attaches to CD20, rituximab helps destroy the B cells.

The approval marks Pfizer’s third oncology monoclonal antibody biosimilar to be approved by the FDA this year, and the drug has also been filed for regulatory approval with the European Medicines Agency (EMA).

24th July 2019

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