Within the framework of the 13th Congress of the European Association of Clinical and Therapeutic Pharmacology (EACPT), held in Prague between 24th and 27th June, Dr Francisco Javier Fernández, medical advisor at mAbxience, presented the results of the population pharmacokinetic modelling the Rituximab (RTXM83) clinical study. It is an international clinical study conducted in 58 centers in 12 different countries whose primary objective was to determine the response (R) obtained with Rituximab Biosimilar in combination with CHOP in patients with diffuse large B-cell non-Hodgkin’s lymphoma (LDCBG ).
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. It is the first time the results of a population analysis of a biosimilar Rituximab are presented. The results showed that biosimilar Rituximab and the reference drug are similar.