Posted by Michael Wonder on 03 Feb 2020
Pfizer receives positive CHMP opinion for oncology biosimilar, Ruxience (rituximab)
31 January 2020 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion, recommending marketing authorisation for Ruxience (rituximab), a potential biosimilar to MabThera (rituximab).
Ruxience is a monoclonal antibody for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.
The CHMP’s opinion will now be reviewed by the European Commission, with a regulatory decision anticipated in the first half of 2020.
The regulatory submission is supported by a comprehensive data package which demonstrates biosimilarity of Ruxience to the reference product.
