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Sandoz' Rituximab Biosimilar Rixathon Wins EC Clearance

05:09 EDT 19 Jun 2017 | Genetic Engineering News

The EC approved Sandoz’ Rixathon ® biosimilar of Roche’s blockbuster monoclonal antibody (mAb) rituximab (MabThera ® /Rituxan ® ). Rixathon is cleared in Europe for use in all MabThera-approved indications, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. "Today's approval of Rixathon represents a big win for patients in Europe with blood cancers or immunological diseases because it enables increased access to biologics,” stated Carol Lunch, global head for Biopharmaceuticals at Sandoz. Rixathon is the second rituximab biosimilar approved in Europe within the last few months. In February the EC cleared Celltrion Healthcare’s rituximab copy Truxima™ as the first biosimilar mAb approved in anywhere in the world for a cancer indication. Clearance of Rixathon in Europe was based on a preclinical and clinical development program to demonstrate that Rixathon matched rituximab safety, efficacy and quality. This included the ASSIST-RA study, ...

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