European Commission Grants Approval of a Rituximab Biosimilar to Treat Blood Cancers, Immunological Diseases

Sandoz has the highest number of biosimilars approved in Europe.

The European Commission recently granted approval to Rixathon—–a biosimilar of rituximab (MabThera)––for use in all indications to the reference product.

Rixathon is approved to treat non-Hodgkin’s lymphoma, including follicular lymphoma and diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. It is also approved to treat immunological diseases, such as rheumatoid arthritis (RA), 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,” Carol Lynch, global head of Biopharmaceuticals at Sandoz, said in a press release. “It also allows health care systems to redeploy resources to other areas of high need, particularly innovative therapies.

The approval was based on a comprehensive development program, which included analytical, preclinical, and clinical data, demonstrating biosimilarity of Rixathon to the reference product rituximab.

Data from 2 clinical studies were included in the approval: the ASSIST-RA and ASSIST-FL studies.

The ASSIST-RA study demonstrated that Rixathon was equivalent to the reference product regarding PK/PD profiles with no clinically meaningful differences in safety, tolerability, or immunogenicity in patients with RA.

The phase 3 ASSIST-FL study confirmed the efficacy and safety of the biosimilar. The study met its primary endpoint of equivalence in overall response rate between Rixathon and the reference product after 6 months, according to the release.

The findings also confirmed the comparable safety profile of the 2 medications.

“Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be 1 of the 5 major launches we plan in the next 4 years,” Lynch said in a release. “We have worked with care and passion towards this approval, and now is the time when we are bringing this medicine to health care professionals and patients in Europe.”