Regulatory Affairs

Sandoz gets EC nod for Rixathon to treat blood cancers and immunological diseases

PBR Staff Writer Published 20 June 2017

Novartis subsidiary Sandoz has secured approval from the European Commission (EC) for its Rixathon (biosimilar rituximab) to treat blood cancers and immunological diseases.

The approval has been granted for Rixathon to be used in all indications of the reference medicine, MabThera.

Novartis has received approval for Rixathon to treat non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, in addition to immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The approval was based on a development program, including analytical, preclinical and clinical data, showing biosimilarity of Rixathon to the reference medicine MabThera.

The ASSIST-RA study, which showed that Rixathon and its reference medicine have equivalent PK/PD profiles, with no clinically meaningful differences in safety, tolerability, or immunogenicity in patients with rheumatoid arthritis.

The study achieved its primary endpoint of equivalence in overall response rate (ORR) between Rixathon and the reference medicine after six months.

With the latest approval, Sandoz currently has four biosimilar medicines approved in Europe. It is also planning to secure approval and launch four more biosimilars of oncology and immunology biologics by 2020.

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.”

Image: Sandoz biopharmaceuticals global head Carol Lynch. Photo: courtesy of Novartis AG.