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The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.
Sandoz, a division of Novartis, announced on June 19, 2017 that the European Commission (EC) has approved Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine, MabThera, the company said in a press release.
In a statement, Carol Lynch, global head of Biopharmaceuticals at Sandoz called the approval a “big win for patients in Europe with blood cancers or immunological diseases.” 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 EC approval was based on a comprehensive development program generating analytical, preclinical, and clinical-including pharmacokinetic/pharmacodynamics-data, the company said. The program demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality.