22Apr 2022
A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication

A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication

This study aimed to compare the pharmacokinetic (PK) and pharmacodynamic (PD) effects and safety of therapeutic dosages of regular insulin produced by Bioton S.A. (experimental drug) versus Humulin® R regular insulin ‐ produced by Eli Lilly (reference drug). The study evaluated 56 participants. The average age and BMI were 32.9 years and 22.9 kg/m2, respectively. The ratios (experimental/reference) of the geometric means of maximum plasma insulin concentration and for plasma insulin area under the curve (AUC) were 0.909 and 0.993, respectively. Test product Regular Human Insulin (Bioton S.A.‐Poland) and comparator Humulin® R (Eli Lilly‐USA) are bioequivalent in patients with T1DM. More expansive entry of more affordable. Affordable, biosimilar regular insulins on the pharmaceutical market may substantially improve access to insulin for many socioeconomically disadvantaged patients with diabetes.

  • #endo-diabetology

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