Sandoz receives approval in Europe for Rixathon (biosimilar rituximab) to treat blood cancers and immunological diseases.
Sandoz, a Novartis division, announced today 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*** 2, 3.
“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,” said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz. “Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches we plan in the next four years. We have worked with care and passion towards this approval, and now is the time when we are bringing this medicine to healthcare professional and patients in Europe.”
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 polyangiitis2.
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 quality4-7.
Sandoz now has four biosimilar medicines approved in Europe. The company said it plans to obtain approval for and launch four more biosimilars of major oncology and immunology biologics by 2020.
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 arthritis6.
- 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 medicines7.
*Sandoz biosimilar rituximab has also been approved in the EU as Riximyo® under a duplicate marketing authorization.
**European Economic Area (EEA). The European Economic Area (EEA) provides for the free movement of persons, goods, services and capital within the internal market of the European Union (EU) between its 28 member states, as well as three of the four member states of the European Free Trade Association (EFTA): Iceland, Liechtenstein, and Norway.
***MabThera® is a registered trademark of F. Hoffmann-La Roche AG.
1 European Medicines Agency. European public assessment reports. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124. [Accessed: June 2017].
2 European Medicines Agency. Rixathon® Summary of Product Characteristics.
3 European Medicines Agency. MabThera® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/2570. [Accessed: June 2017].
4 Visser J, et al. Physicochemical and Functional Comparability Between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab. BioDrugs. 2013; 27: 495-507.
5 Da Silva A, et al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma. 2014; 55: 1609-1617.
6 Smolen J, et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of proposed rituximab biosimilar (GP2013) vs. EU-Approved rituximab (rtx) in patients with rheumatoid arthritis: results from a randomized controlled trial (GP13-201) over 52 weeks. EULAR congress, 8-11 June 2016, London, UK: FRI0222.
7 Jurczak W, et al. A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma. ASH annual meeting, 3-6 December 2016, San Diego, USA: 1809.