Authors' recommendations: No good-quality studies were found comparing the clinical efficacy and safety outcomes of MabThera® rituximab (Roche) with other rituximab biosimilars. The only biosimilar currently approved in Argentina (based on safety studies) is Novex® rituximab (Elea). No published results from any clinical trial approved by the Argentine National Administration for Drugs, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de Argentina, ANMAT) comparing the use of MabThera® rituximab with the Novex® biosimilar for diffuse B-cell lymphoma have been found. Studies for other approved indications (rheumatoid arthritis, chronic lymphocytic leukemia, Wegener's granulomatosis and microscopic polyangiitis) have not been found either. Both the World Health Organization and the United States, European and Latin American regulatory agencies have set international standards for biosimilar molecule development and regulation. Rituximab biosimilars are at investigational stage. Some Asian and Latin American countries have rituximab molecules which are copy intents (approved not having conducted bioequivalence studies). The Argentina Rheumatology Society consider the use of biosimilar molecules for rheumatoid arthritis provided they meet the clinical trial approval standards. The Argentina Hematology Society does not make reference to the use of biosimilars. The difference in the price of both rituximabs in Argentina is approximately 10%.

Project Status: Completed

Year Published: 2016

URL for published report: 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)