The journnal Cancer Chemotherapy and Pharmacology has recently published the randomized, double-blind, phase III and comparative clinical study of pharmacokinetics and pharmacodynamics between RTXM83 rituximab biosimilar and its reference product in diffuse large B-cell lymphoma patients (Press release, mAbxience, MAR 6, 2018, View Source [SID1234525381])

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The main objective was to quantify any potential differences in pharmacokinetic (PK) parameters (AUC and Cmax). To demonstrate biosimilarity at pharmacokinetic level as required by regulatory agencies, a population pharmacokinetic analysis was performed to compare RTXM83 with respect to the reference product. For this purpose, 5,431 serum samples from 251 recruited patients were used. The systemic exposure of RTXM83 and its associated variability were similar to those for rituximab reference, demonstrating PK similarity. The PD similarity of RTXM83 and rituximab reference product was also demonstrated.