Pfizer's biosimilar Rituxan has been approved by the FDA

the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.'s Ruxience (rituximab-pvvr), a biosimilar similar to Roche's Rituxan.The treatment has been approved for the treatment of adult patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and granuloma accompanied by polyvascularitis (GPA) and microscopic multivascularitis (MPA).The approval was based on a review of the comprehensive packet, which demonstrated the biological similarity between Ruxxan and Rituxan, including the results of the REFLECTIONSB3281006 clinical comparative study, which assessed the efficacy, safety and immunogenicity of biosimilars, pharmacogenetics and pharmacology, and clinically found no clinical differences in the safety or efficacy of CD20-positive patients with low tumor load blistering lymphoma.“ Lytoxi monoantigen, which was initially approved by the FDA as one of the first monoclonal antibody (mAb) cancer treatments, represents significant progression and is the only available option for oncologists and their patients for a period of time," said Dr. Jeff Sharman, Director of Hematology Research Medicine at oncology in the United States. TheRituxan and its biosimilars both work by targeting a protein called CD20, which is present on the surface of B cells. When it is attached to CD20, lysoxi monoantigen helps destroy B cells.The approval marks Pfizer's third FDA-approved oncology monoclonal antibody biosimilar this year, and the drug has also been regulatoryly approved by the European Medicines Agency (EMA). （cyy123.com）