Case Study: Sandoz’s EU approval for Rixathon

Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) has approved Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine, MabThera. Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches what Sandoz plan in the next four years.

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.

The EC 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.

EC approval was based on a comprehensive development program, including analytical, preclinical, and clinical data, demonstrating biosimilarity of Rixathon to the reference medicine, MabThera^®. Clinical studies included:

• The ASSIST-RA study, which demonstrated 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 ASSIST-FL study; a Phase III confirmatory efficacy and safety study. The study met its primary endpoint of equivalence in overall response rate (ORR) between Rixathon and the reference medicine after six months. Results also confirmed the comparable safety profile of the two medicines

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilar medicines. It is the pioneer and global leader in biosimilars, and now has four biosimilar medicines approved in Europe. Sandoz has a leading biosimilar pipeline, and plans to obtain approval for and launch four more biosimilars of major oncology and immunology biologics by 2020. A division of the Novartis Group, Sandoz is well positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing, and commercialization.