European Commission (EC) has approved Sandoz’s Rixathon (biosimilar rituximab) for use in all indications of the reference medicine, MabThera.
“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. It also allows healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies” said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz. “Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches we plan in the next four years. We have worked with care and passion towards this approval, and now is the time when we are bringing this medicine to healthcare professional and patients in Europe.”
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, Novartis’s biosimilars division said in its press release.
The company said that the approval was based on a comprehensive development program generating analytical, preclinical, and clinical – including pharmacokinetic/ pharmacodynamic (PK/PD) – data. The program demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality.