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Detection of recombinant erythropoietin biosimilar JimaixinTM after administration in healthy subjects.

JimaixinTM (Jintan Ltd, China) is a biosimilar of recombinant erythropoietin (rEPO) now authorized for therapeutic application in China. With a risk of abuse by athletes, a clear evaluation of its detection using the electrophoretic methods in use in antidoping laboratories was necessary. In a previous work, we showed that JimaixinTM electrophoretic profile presented slight changes compared to the original drug (first generation rEPO) and that a spike of JimaixinTM in urine and serum was well identified by SDS-PAGE but with less performance by IEF-PAGE unless a neuraminidase treatment was applied first. The aims of this research were to perform an intravenous administration of JimaixinTM on 3 healthy subjects (one microdose (10 IU/kg) and 3 therapeutic doses (50 IU/kg)) and to evaluate the detection in urine and blood up to 7 days post-administration. Analysis of the samples showed that JimaixinTM detection was complicated by IEF-PAGE due to the loss of the most distinctive basic isoforms. In addition, a neuraminidase treatment did not improve detection (contrary to the observations from spike experiments). On the contrary JimaixinTM was very efficiently detected in blood and urine by SDS-PAGE: up to 40h after a microdose and up to 7 days after the therapeutic doses. The effect of JimaixinTM on hematological parameters was limited to a clear but transitory increase of the reticulocytes. These data give new elements to better survey a potential misuse of JimaixinTM by athletes.