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Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar insulin N with US‐licensed Humulin® N formulation in healthy subjects: Results from the RHINE‐2 (Recombinant Human INsulin Equivalence‐2) study.
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- Author(s): Andersen, Grit; Singh, Gursharan; Murugesan, Sundara Moorthi Nainar; Gogineni, Rajesh; Sharma, Nirant; Panda, Jayanti; Marwah, Ashwani; Loganathan, Subramanian; Athalye, Sandeep N.
- Source:
Diabetes, Obesity & Metabolism; Jun2023, Vol. 25 Issue 6, p1485-1494, 10p- Subject Terms:
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- Additional Information
- Subject Terms:
- Subject Terms:
- Abstract: Aim: To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin N (Biocon's Insulin‐N; Biocon Biologics Ltd., Bangalore, India) and US‐licensed Humulin® N (Humulin‐N; Eli Lilly and Company, Indianapolis, IN, USA) in healthy subjects. Materials and Methods: This was a phase‐1, single‐centre, double‐blind, randomized, three‐period, six‐sequence, partially replicated, crossover, 24‐h euglycaemic clamp study. Overall, 90 healthy subjects were randomized, of whom 85 completed the study. The subjects received either two single doses of Biocon's Insulin‐N and a single dose of Humulin‐N or two single doses of Humulin‐N and a single dose of Biocon's Insulin‐N subcutaneously at a dose of 0.4 IU/kg. The primary PK endpoints were the area under the insulin concentration‐time curve from 0 to 24 h (AUCins.0‐24h) and the maximum insulin concentration (Cins.max). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 h (AUCGIR.0‐24h) and the maximum GIR (GIRmax). Results: Biocon's Insulin‐N was found to be equivalent to Humulin‐N for the primary PK (geometric 90% confidence interval for the least squares mean ratio: AUCins.0‐24h, 100.98%‐115.66% and Cins.max, 95.91%‐110.16%) and PD endpoints (intra‐subject variability ≥0.294; 95% upper confidence interval [(μT – μR)2 − θσ2WR] <0; point estimates of geometric least squares mean ratio: AUCGIR.0‐24h, 104.61% and GIRmax, 100.81%). The safety profile of Biocon's Insulin‐N was similar to that of Humulin‐N, and no serious adverse events were reported. Conclusion: PK and PD equivalence was shown between Biocon's Insulin‐N and Humulin‐N in healthy subjects, and both treatments were well tolerated and considered safe. [ABSTRACT FROM AUTHOR]
- Abstract: Copyright of Diabetes, Obesity & Metabolism is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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