Posted by Michael Wonder on 19 Jun 2017
Sandoz receives approval in Europe for Rixathon (biosimilar rituximab) to treat blood cancers and immunological diseases
19 June 2017 - Sandoz now has four biosimilars approved in Europe — more than any other company.
Sandoz announced today that the European Commission has approved Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine, MabThera.
Rixathon is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis,
The European Commission approval was based on a comprehensive development program generating analytical, preclinical, and clinical — including pharmacokinetic/pharmacodynamic — data. The program demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality.
