In:
Diabetes, Obesity and Metabolism, Wiley, Vol. 25, No. 6 ( 2023-06), p. 1485-1494
Abstract:
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 (AUC ins.0‐24h ) and the maximum insulin concentration (C ins.max ). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 h (AUC GIR.0‐24h ) and the maximum GIR (GIR max ). 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: AUC ins.0‐24h , 100.98%‐115.66% and C ins.max , 95.91%‐110.16%) and PD endpoints (intra‐subject variability ≥0.294; 95% upper confidence interval [(μT – μR) 2 − θσ 2 WR] 〈 0; point estimates of geometric least squares mean ratio: AUC GIR.0‐24h , 104.61% and GIR max , 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.
Type of Medium:
Online Resource
ISSN:
1462-8902
,
1463-1326
Language:
English
Publisher:
Wiley
Publication Date:
2023
detail.hit.zdb_id:
2004918-3
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