Pharmacokinetic comparison of two recombinant human granulocyte colony-stimulating factor after subcutaneous administration in rabbits

Abstract A pharmacokinetic comparison between two formulations (LeukoCIM, CIMAB SA versus Neupogen ® , Hoffman-La Roche, licensed by Amgen) of recombinant human granulocyte colony-stimulating factor (rhG-CSF) using non-compartmental analysis was performed in male F1 rabbits after a single subcutaneous 11.5 μg/kg dose to help decide whether to conduct further comparability tests. Unlike the absorption phase, a statistical difference was not detected between Neupogen ® and LeukoCIM for clearance (18.69±11.83 versus 28.42±12.11 mL/h/kg, P =0.22). In addition, using a multivariate statistical analysis by independent samples test, a significant difference was not found between the two formulations ( P =0.88). Finally, the results obtained in this study confirmed the pharmacokinetic comparability between both formulations, supporting the claim for further assessments following the current protocol on biogeneric equivalence.