Lancet Haematology publishes data demonstrating Sandoz Rixathon® (biosimilar rituximab) matches efficacy and safety of reference biologic
Aug 29, 2017
Lancet Haematology publishes data from ASSIST-FL study of Sandoz Rixathon®, in patients with previously untreated advanced follicular lymphoma
ASSIST-FL, results of which were first announced in December 2017, achieved its primary endpoint1
Rixathon® received European Commission approval for use in all indications of the reference biologic in June 2017 2,3
Holzkirchen, August 29, 2017 – Lancet Haematology has published data from the ASSIST-FL trial demonstrating that the efficacy and safety of Sandoz Rixathon® (biosimilar rituximab) matches that of the reference biologic MabThera®* in follicular lymphoma.1 The newly published data formed part of the submission package on which the European Commission based its recent approval of Rixathon for the treatment of follicular lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia and several immunological diseases.
The ASSIST-FL trial met its primary endpoint of equivalence of overall response rate between Rixathon and the reference biologic at the end of induction treatment.1 Equivalent efficacy, comparable safety, pharmacokinetics and pharmacodynamics between Rixathon and the reference medicine were demonstrated.1
“The publication of these data in Lancet Haematology further evidences that our biosimilar rituximab, recently approved as Rixathon, is a valuable new treatment option for patients with life-threatening blood cancers, as well as immunological diseases,” said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “Oncology services are under increasing pressure and new strategies are needed to ensure patients are able to access treatment. By making Rixathon available in Europe we aim to tackle these barriers and make it possible for more people to benefit from rituximab moving forward.”
Follicular lymphoma is the second most common non-Hodgkin lymphoma – accounting for approximately 10-20% of all lymphomas in Western countries.4 Although it is more common in people over the age of 50, it can occur at any age.5
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 five biosimilar medicines approved in Europe – more than any company. Sandoz has a leading biosimilar pipeline and plans to launch a total of five major oncology and immunology biosimilars between 2017 and 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.
AboutRixathon Rixathon is the Sandoz biosimilar of the reference medicine, MabThera®. Rixathon has been studied in a global development program that included a comprehensive comparison of Rixathon and the reference medicine at the analytical, preclinical, and clinical levels. It has received approval from the European Commission for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases including rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
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About Sandoz Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
*MabThera® is a registered trademark of F. Hoffmann-La Roche AG
Jurczak, W et al. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematology. Online first publication DOI: http://dx.doi.org/10.1016/S2352-3026(17)30106-0