Pfizer gets FDA nod for biosimilar Rituxan

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Pfizer gets FDA nod for biosimilar Rituxan

By Sandra Levy - 07/24/2019
Pfizer has received the Food and Drug Administration’s green light for Ruxience (rituximab-pvvr), a biosimilar to Genentech's Rituxan. It is indicated for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

“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 of Pfizer Oncology. “The FDA approval marks our third oncology biosimilar to be approved in the United States this year, reinforcing our commitment to bring these important medicines to patients living with cancer.”

"Rituximab became one of the first monoclonal antibody, or 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 Jeff Sharman, medical director, U.S. Oncology Hematology 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.”

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