Reditux is a medicine from Dr. Reddy's laboratories. It is the first biosimilar version of rituximab globally, an anti-CD20 antibody used in the treatment of certain lymphomas, leukemias and rheumatoid arthritis.
Reditux was approved for usage in India in 2007. It was approved on the basis of a single-arm pharmacokinetic, pharmacodynamic, efficacy and safety study in patients (n=71) with diffuse large B-cell lymphoma (DLBCL). Data from the pharmacokinetic cohort (n=17) from this study has been published in abstract form.
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).
Reditux is also available in Iran (marketed by Cinnagen), Colombia and Peru. It is marketed in Paraguay by FARMASA as Tidecron.