FDA approves Pfizer’s biosimilar version of Genentech’s Rituxan

pharmafile | July 24, 2019 | News story | Research and Development FDA, Pfizer, Rituxan, Ruxience, biosimilars, pharma 

Pfizer has seen Ruxience, its biosimilar version of Genentech’s Rituxan (rituximab), approved by the FDA in the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukaemia, and granulomatosis with polyangiitis and microscopic polyangiitis. While rheumatoid arthritis is also an approved indication of the reference product, the approval of Ruxience did not cover this disease area.

The marketing authorisation follows the submission of data which demonstrated that Ruxience was comparable in terms of efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics to its reference product in patients with CD20-positive, low tumour burden follicular lymphoma, resulting in “sustained, profound” B cell suppression up after 25 weeks of treatment.

“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,” commented Dr Jeff Sharman, Medical Director, US 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.”

Andy Schmeltz, Global President of Pfizer Oncology, also remarked on the approval: “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. The FDA approval marks our third oncology biosimilar to be approved in the US this year, reinforcing our commitment to bring these important medicines to patients living with cancer.”

Ruxience is also currently awaiting review by the European Medicines Agency.

Matt Fellows

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