Equivalence of Biosimilarity in Pharmacokinetic and Pharmacodynamic Properties of Recombinant Human Insulin Aspart.

Abstract

Insulin aspart, a rapid-acting analog, achieves faster subcutaneous absorption than regular insulin. This study aimed to demonstrate equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of Recombinant Human Insulin Aspart from BioGenomics Limited (as test) and Novo-Nordisk (as reference) in healthy adult males. This was a double-blind, randomized, cross-over study, assessing PK and PD parameters under fasting conditions. Participants received either 0.2 U/kg of test or reference product via a subcutaneous route in the abdominal area. PK parameters included maximum serum concentration (C_max), area under the curve [(AUC_[0-t]) and (AUC _[0-∞])], time to maximum serum concentration (T_max), and half-life (t_½). PD parameters included amount of glucose infused (G_tot), maximum glucose infusion rate (R_max), time of R_max (tR_max), late time of half-maximal glucose infusion rate (tR_max50), time of first measured glucose infusion rate (t_onset), and cessation of glucose infusion/clamp (tR_last). Seventy subjects between 18 and 45 years of age and body mass index between 18 and 27 kg/m² were enrolled. The 90% confidence intervals (CIs) for C_max, AUC_[0-t], AUC _[0-∞] for insulin, and the 95% CIs for G_tot, R_max for glucose were within 80%-125% as required to assess test-reference bioequivalence. No serious adverse events were observed. Both the preparations showed bioequivalence under fasting conditions with a similar safety profile.