Posted by Michael Wonder on 15 Mar 2017
First biosimilar monoclonal antibody in oncology granted EU approval: implications for the U.S. market
14 March 2017 - Recent developments in Europe may augur a new push for oncology biosimilars in the United States.
On 22 February 2017, the European Commission approved Celltrion’s Truxima for all indications of reference rituximab (marketed as Rituxan), the world’s top selling cancer drug in 2015.
Truxima, the first biosimilar monoclonal antibody approved in an oncology indication in Europe, is approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
