22 February 2017 - Truxima is expected to cost less than the reference product and the hope is that these savings could potentially free up budgets for other innovative cancer medications.
Mundipharma and its network of independent associated companies will launch Truxima (rituximab) in the UK, Germany, Italy, Netherlands, Belgium, Republic of Ireland and Luxembourg, following authorisation by the EMA. Truxima is the first biosimilar monoclonal antibody authorised by the European Commission for the treatment of cancers, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukaemia.
The marketing authorisation of Truxima was granted by the EMA on the basis of a rigorous comparability exercise that included preclinical and clinical testing. As a result, it has been demonstrated via quality, nonclinical and clinical data that all major physicochemical characteristics and biological activities of Truxima were comparable to those of the reference product. Like the reference product, Truxima is therefore authorised for the treatment of diffuse large B cell lymphoma, follicular lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.