Authors: Leona Plum-Mörschel, Oliver Klein, Gursharan Singh, Sundara Moorthi Nainar Murugesan, Ashwani Marwah, Nirant Sharma, Jayanti Panda, Subramanian Loganathan, Gopu Chandrasekharan Lakshmi, Sandeep N Athalye
Date: Sep 24th, 2022
Aim: To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon’s Insulin-70/30) and HUMULIN® 70/30 (HUMULIN-70/30; Eli Lilly and Company, IN).
Materials and methods: In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon’s Insulin-70/30 and HUMULIN-70/30. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 24 hours – AUCins.0-24h – and maximum insulin concentration – Cins.max . Primary PD endpoints were area under the GIR time curve from 0 to 24 hours – AUCGIR.0-24h – and maximum GIR – GIRmax .
Results: Equivalence was shown between Biocon’s Insulin-70/30 and HUMULIN-70/30 for the primary PK/PD endpoints. The 90% confidence intervals of the treatment ratios were entirely within the acceptance range of 80.00%-125.00%. The secondary PK/PD profiles were also comparable. There were no clinically relevant differences in the safety profiles of the two treatments and no serious adverse events were reported.
Conclusion: PK/PD equivalence was demonstrated between Biocon’s Insulin-70/30 and HUMULIN-70/30 in healthy subjects. Treatment with Biocon’s Insulin-70/30 and HUMULIN-70/30 was well tolerated.
Conflict of interest statement: LPM has received speaker honoraria and travel grants from Eli Lilly, Gan & Lee Pharmaceuticals and Novo Nordisk. GS, AM, JP, SL and SNA are employees of Biocon Biologics Ltd and hold stocks in Biocon. SMNM and GCL are employees of Biocon Biologics Ltd. NS was employed with Biocon Biologics Ltd at the time of study conduct and preparation of the manuscript but is no longer employed by Biocon Biologics Ltd. OK is an employee of Profil, Neuss, Germany and has nothing to disclose.