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Rituximab Biosimilar Nears EU Approval for Oncologic and Other Indications

Gina Columbus @ginacolumbusonc
Published: Monday, Feb 03, 2020

Chris Boshoff, MD, PhD

Chris Boshoff, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab (Rituxan) biosimilar PF-05280586 (rituximab-pvvr; Ruxience) for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris.1

The regulatory submission is supported by a comprehensive data package demonstrating biosimilarity with PF-05280586 to reference rituximab, including results from the REFLECTIONS B3281006 study that evaluated the efficacy, safety and immunogenicity, pharmacokinetics, and pharmacodynamics of PF-05280586. Results showed that there were no clinically meaningful differences in safety or efficacy between the biosimilar and standard rituximab in patients with CD20-positive, low tumor burden follicular lymphoma.2

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