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.