On January 31, 2020 Pfizer Inc. (NYSE: PFE) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for RUXIENCE (rituximab),1 a potential biosimilar to MabThera (rituximab).2,3 RUXIENCE is a monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV) (Press release, Pfizer, JAN 31, 2020, View Source [SID1234553744]).1 The CHMP’s opinion will now be reviewed by the European Commission, with a regulatory decision anticipated in the first half of 2020.
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"Biosimilars like RUXIENCE can play an important role in cancer care, helping to expand patient access to potentially life-changing therapies," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "We are committed to bringing biosimilars like RUXIENCE to the market as a treatment option with similar safety and efficacy to the originator product at a potentially lower cost. If approved, RUXIENCE would become Pfizer’s fifth oncology biosimilar to receive regulatory approval in Europe."
The regulatory submission is supported by a comprehensive data package which demonstrates biosimilarity of RUXIENCE to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of RUXIENCE and found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma.4
Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to help create a more sustainable healthcare system. With more than 10 years of global in-market experience and five approved biosimilar products in Europe, Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. RUXIENCE was also approved for use in the United States for the treatment of adult patients with NHL, CLL, GPA and MPA in 2019 and was recently made available to U.S. patients.