Home » Pfizer’s MabThera Biosimilar Nabs European Approval
Pfizer’s MabThera Biosimilar Nabs European Approval
The European Commission has approved Pfizer’s Ruxience (rituximab) for treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.
The approval was based on the results of a clinical trial that found no clinically meaningful differences in the drug’s safety or efficacy compared to Roche’s MabThera in patients with CD20-positive, low-tumor-burden follicular lymphoma.
Ruxience was recently made available to adult patients in the U.S. for several of the same indications and launched in Japan in January.
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