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)

Abstract

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 AUCASP.0-2h and AUCGIR.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. Disclosure L. Plum-moerschel: None. E. H. Uhrmacher: None. E. Zijlstra: Speaker’s Bureau; Self; Novo Nordisk A/S. J. Lu: Employee; Self; Gan & Lee Pharmaceuticals. M. G. Wilson: Consultant; Self; Gan & Lee Pharmaceuticals, Employee; Spouse/Partner; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. M. E. Barton: Employee; Self; Gan & Lee Pharmaceuticals. T. Heise: Advisory Panel; Self; Novo Nordisk A/S, Valbiotis, Research Support; Self; ADOCIA, Afon Technology Ltd., AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Gan & Lee Pharmaceuticals, Johnson & Johnson, Julphar, Mylan N. V., Nestle, Neuraly, Nordic Bioscience, Novo Nordisk, Sanofi, Zealand Pharma A/S, Speaker’s Bureau; Self; Novo Nordisk A/S. Funding Gan & Lee Pharmaceuticals