4. Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin-R with the US-licensed Humulin® R formulation in healthy subjects: Results from the RHINE-1 (Recombinant Human INsulin Equivalence-1) study
- Jan 3rd, 2022
- Leona Plum-Mörschel MD, PhD, Gursharan Singh MBBS, PhD, Sundara Moorthi Nainar Murugesan MPharm, PhD, Ashwani Marwah MSc, Jayanti Panda MPharm, Subramanian Loganathan MD, Sandeep N. Athalye MD
Abstract –
Aim: To establish equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) endpoints between proposed biosimilar Insulin-R (Biocon’s Insulin-R) and Humulin® R using the euglycaemic clamp technique in healthy subjects.
Materials and methods: In this phase-1 automated euglycaemic glucose clamp study, 42 healthy subjects were randomized (1:1) to receive a single dose of 0.3 IU/kg of Biocon’s Insulin-R and Humulin-R. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 12 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 12 hours (AUCins.0-12h) and maximum insulin concentration (Cins.max). Primary PD endpoints were area under the GIR time curve from 0 to 12 hours (AUCGIR.0-12h) and maximum GIR (GIRmax).
Results: Equivalence was demonstrated between Biocon’s Insulin-R and Humulin-R for the primary PK and PD endpoints. The 90% confidence intervals were within 80.00% to 125.00% limits. The PK and PD profiles were comparable. There were no significant differences in the safety profiles of the two treatments, and no serious adverse events were reported.
Conclusion: PK and PD equivalence was demonstrated between Biocon’s Insulin-R and Humulin-R in healthy subjects. Treatment with Biocon’s Insulin-R and Humulin-R was well tolerated.
Conflict of interest statement: GS, SMNM, AM, JP, SL, and SNA are employees of Biocon Biologics Ltd. LP-M has received speaker honoraria and travel grants from Eli Lilly and Company and Novo Nordisk. GS, AM, JP, SL, and SNA hold stocks in Biocon.
