Sandoz Announces European Approval of Biosimilar Rituximab

Sandoz announced today that its biosimilar rituximab product has been approved by the European Commission to treat blood cancers and immunological diseases. Sandoz’s product will be marketed as both Rixathon and Riximyo under a duplicate marketing authorization.

Sandoz’s rituximab is approved for use in all indications of its reference, Roche’s MabThera, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The European Commission based its approval on analytical, preclinical, and clinical data, including pharmacokinetic (PK) and pharmacodynamic (PD) data that demonstrated equivalent safety, efficacy, and quality of the biosimilar and reference treatments. Clinical studies for the biosimilar included a phase 3 efficacy and safety study in patients with previously untreated advanced follicular lymphoma. The study met its primary endpoint of demonstrating equivalence in overall response rate to the reference product, and additionally demonstrated similarity in efficacy, PK and PD.

"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,” said Carol Lynch, global head of biopharmaceuticals at Sandoz. “It also allows healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies," Lynch added.

Sandoz’s product joins Celltrion’s Truxima, another biosimilar rituximab, in the European marketplace. Celltrion’s product, granted European authorization in February of 2017, has already been supplied to 50 hospitals in the United Kingdom. According to Celltrion, patient populations treated with Truxima included patients who were switched to the biosimilar. Competition from Sandoz and Celltrion poses a challenge to Roche, which relied on its innovative product for approximately $7.2 billion of its global sales in 2016.