CHMP recommends Ruxience a biosimilar to MabThera.-Pfizer

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ruxience, intended for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and Pemphigus vulgaris (PV). The applicant for this medicinal product is Pfizer Europe MA EEIG. Ruxience will be available as 100 mg and 500 mg concentrates for solution for infusion. The active substance of Ruxience is rituximab, a monoclonal antibody (ATC code: L01XC02) that binds specifically to the transmembrane protein CD20 found on both malignant and normal B cells. In NHL and CLL, this promotes destruction of malignant B cells and thus controls tumour growth. In RA, GPA, MPA and PV it reduces the number of B cells involved in their pathogenesis. Ruxience is a biosimilar medicinal product. It is highly similar to the reference product MabThera, which was authorised in the EU on 2 June 1998. Data show that Ruxience has comparable quality, safety and efficacy to MabThera (rituximab).