EC approves Sandoz’s Rixathon for blood cancer and immunological diseases
Novartis division Sandoz’s Rixathon (biosimilar rituximab) has received approval from the European Commission (EC) to treat blood cancers and immunological diseases in Europe.
Rixathon is approved for use in all indications of the reference medicine, MabThera.
Sandoz Biopharmaceuticals global head Carol Lynch said: “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.
“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.”
The treatment is currently approved for non-Hodgkin lymphoma (follicular lymphoma and diffuses large B-cell lymphoma) and chronic lymphocytic leukaemia, in addition to immunological diseases such as rheumatoids arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
The approval was based on a comprehensive development programme generating analytical, preclinical, and clinical data, including pharmacokinetic / pharmacodynamic (PK/PD) data.
The programme demonstrates the biosimilarity of Rixathon to its reference medicine MabThera in terms of safety, efficacy and quality.
Image: High-power magnification (1000 X) of a Wright's stained peripheral blood smear showing chronic lymphocytic leukaemia. Photo: courtesy of VashiDonsk at the English language Wikipedia.