Original Title: Biosimilares de rituximab

Authors' recommendations: CONCLUSIONS The TRUXINA® (CT-P10 molecule) rituximab is the only biosimilar approved by the European Agency of Medicines in February 2017, and it may be exchanged with MABTHERA® (Roche) rituximab since it meets the international standards for biosimilar molecule development stated by the World Health Organization and the regulatory agencies from the United States, Europe and Latin America. No randomized trials comparing the efficacy and safety clinical outcomes of MABTHERA® (Roche) rituximab versus other biosimilars under development have been found. At present, NOVEX® (ELEA) rituximab is approved in Argentina. No published clinical trial results comparing the use of the reference rituximab with the NOVEX® biosimilar have been found for the indications authorized by the Argentine National Administration of Drugs, Food and Medical Technology (ANMAT) (diffuse B-cell lymphoma, rheumatoid arthritis, chronic lymphatic leukemia, Wegener’s granulomatosis and microscopic polyangiitis). Studies with NOVEX® have not been found in the indexed literature either. Anyway, if approved by ANMAT, it should be considered as a bioequivalent for the approved indications. The Argentine Rheumatology Society considers the use of biosimilar molecules adequate in rheumatoid arthritis as long as the clinical trial approval standards are met. The Argentine Hematology Society does not make reference to the use of biosimilars. The difference in the price of both rituximabs in Argentina is approximately 10%. As regards the NOVEX® rituximab coverage policy, according to the Argentine regulations, it is approved by ANMAT so it is considered a biosimilar to the original rituximab. Therefore, the coverage policy used for the approved indications of NOVEX® rituximab would be the same as for those of the original rituximab. However, it should be noted that no studies assessing the effectiveness and/or the safety of NOVEX® rituximab have been found.

Project Status: Completed

Year Published: 2017

URL for published report: https://www.iecs.org.ar/home-ets/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)