Biosimilar Ruxience Approved for Some Blood Cancers and Autoimmune Conditions

The FDA has approved rituximab-pvvr (Ruxience, Pfizer), a rituximab biosimilar (Rituxan), for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

Rituximab-pvvr is a mAb biosimilar to Rituxan that targets the protein CD20, which is present on the surface of B cells. When it attaches to CD20, rituximab helps destroy the B cells.

The approval was based on a review of data demonstrating rituximab-pvvr’s biosimilarity to the reference product, including results from the REFLECTIONS B3281006 clinical comparative study. The study evaluated the efficacy, safety and immunogenicity, pharmacokinetics, and pharmacodynamics of rituximab-pvvr.

The most common side effects reported in patients treated with rituximab-pvvr are infusion-related reactions, fever, lymphopenia, neutropenia, chills, infection, weakness, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.

Source: Centers for Biosimilars and Healio, July 23, 2019