738-P: Proposed Biosimilar Gan & Lee Insulin Aspart (GL-ASP) Shows Pharmacokinetic (PK) and Pharmacodynamic (PD) Bioequivalence (BE) to U.S.- and EU-Licensed Insulin Aspart (ASP)

This randomized, double-blind, three-way crossover trial (NCT04237129) investigated the PK and PD properties of GL-ASP, a proposed biosimilar ASP by Gan & Lee, US licensed Novolog® and EU authorized NovoRapid® (US-ASP and EU-ASP) in 36 healthy male subjects (mean±SD age 36±12 years, BMI 24.3±2.7 kg/m²). Each subject received a single 0.2 U/kg dose of either GL-ASP, US-ASP or EU-ASP in each of the 3 euglycemic glucose clamp periods (ClampArt, clamp level 81 mg/dl, clamp duration 12h post-dose). GL-ASP and comparator insulins showed superimposable ASP concentration- and glucose infusion rate (GIR) profiles (Figure). PK BE was demonstrated between GL-ASP and the two comparator insulins as serum ASP concentration point estimates (using log-transformed data) were close to 100% and 90% CIs were well contained within the pre-defined similarity margins of 80-125% (Figure). Likewise, the primary PD endpoints met BE-criteria as did the secondary PK/PD-endpoints AUC_ASP.0-2h and AUC_GIR.0-2h. Sensitivity analyses with untransformed data or exclusion of profiles with C-peptide increases confirmed PD BE. Adverse events were rare with all insulins (7-14 events per insulin, only 1 injection site reaction [mild erythema] with GL-ASP).

In conclusion, GL-ASP demonstrated both PK- and PD-bioequivalence to US- and EU-licensed ASP formulations.

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