Posted by Michael Wonder on 02 Apr 2020
Pfizer receives European approval for oncology biosimilar Ruxience (rituximab)
2 April 2020 - Pfizer today announced that the European Commission has approved Ruxience (rituximab), a monoclonal antibody and biosimilar to MabThera (rituximab), for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis and pemphigus vulgaris.
The approval is based on a comprehensive data package which demonstrated 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 tumour burden follicular lymphoma.
