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Reditux is the trade name of a non-comparable biologic (NCB) version of rituximab, an anti-CD20 antibody used in the treatment of certain lymphomas, leukaemias and rheumatoid arthritis. Reditux is a biosimilar of Rituximab (Mabthera™). Rituximab (Mabthera™) have been in use in India since 2000. Reditux a biosimilar molecule of rituximab (Reditux™) was approved in India in 2007.〔http://www.ncbi.nlm.nih.gov/pubmed/24604960. Comparison of the efficacy and safety of Rituximab (Mabthera™) and its biosimilar (Reditux™) in diffuse large B-cell lymphoma patients treated with chemo-immunotherapy: A retrospective analysis.〕 This retrospective audit was done to compare the efficacy and safety of Mabthera™ with Reditux™. It was approved on the basis of a 17 patients phase II study in diffuse large B-cell lymphoma (DLBCL). Based on Comparison of the efficacy and safety of Rituximab (Mabthera™) and its biosimilar (Reditux™) in diffuse large B-cell lymphoma patients treated with chemo-immunotherapy: Of the 223 patients evaluated, 101 received Mabthera™, 72 received Reditux™. There were no differences in the infusional reaction rates, grades 3 and 4 neutropenia and oral mucositis between the two brands. Complete-remission (CR) rates were similar with Mabthera™ and Reditux™ (75% and 82%, respectively; P = 0.294). The progression free survival (PFS) rate at 5 years were 72% in Mabthera™ and 81% in Reditux™ (P = 0.382). The overall survival (OS) at 5 years were comparable in the two groups (66% in Mabthera™ and 76% in Reditux™; P = 0.264). For a product to be classified as a biosimilar, it must have been developed via a rigorous comparability exercise versus an approved reference medicinal product (RMP) that has been laid down as part of national biosimilar guidelines. Examples of this type of biosimilar pathway include the European Medicines Agency (EMA)〔http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002958c EMA Biosimilar Guidelines〕 and the US Food & Drug Administration (FDA).〔http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm FDA Biosimilar Guidelines〕 Reditux is produced by Dr. Reddy's Laboratories, India's largest pharmaceutical company. It was first launched on April 30, 2007 in Hydrabad, India.〔http://www.biomarketgroup.com/content/view/122/7/ Extended Views: Dr Reddy's: Indian generic Rituxan launch flashes warning to biologics industry〕 Reditux is also available in Iran (marketed by Cinnagen), Colombia and Peru. It is marketed in Paraguay by FARMASA as Tidecron.〔http://www.firstwordplus.com/biosimilar_index.do Biosimilar Index: Tracking the Biosimilar Development Landscape〕 ==References== Some South-American countries have questioned the security of this drug. http://elcomercio.pe/lima/724847/noticia-cuestionan-cualidades-farmaco-usado-tratamientos-oncologicos_1 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Reditux」の詳細全文を読む スポンサード リンク
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