Article ; Online: Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced reference insulins.
Diabetes, obesity & metabolism
2023 Volume 25, Issue 12, Page(s) 3817–3825
Abstract: ... Lee pharmaceuticals, to the respective EU- and US-reference products in healthy male participants (GL ...
| Abstract | Aim: For the successful approval and clinical prescription of insulin biosimilars, it is essential to show pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to the respective reference products sourced from the European Union and the United States. Methods: Three phase 1, randomized, double-blind, three-period crossover trials compared single doses of the proposed biosimilar insulin analogues aspart (GL-Asp, n = 36), lispro (GL-Lis, n = 38) and glargine (GL-Gla, n = 113), all manufactured by Gan & Lee pharmaceuticals, to the respective EU- and US-reference products in healthy male participants (GL-Asp and GL-Lis) or people with type 1 diabetes (GL-Gla). Study participants received 0.2 U/kg (aspart and lispro) or 0.5 U/kg (glargine) of each treatment under automated euglycaemic clamp conditions. The clamp duration was 12 h (aspart and lispro) or 30 h (glargine). Primary PK endpoints were the total area under the PK curves (AUC Results: Bioequivalence to both EU- and US-reference products were shown for all three GL insulins. Least squares mean ratios for the primary PK/PD endpoints were close to 100%, and both 90% and 95% confidence intervals were within 80%-125% in all three studies. There were no noticeable differences in the safety profiles between test and reference insulins, and no serious adverse events were reported for the GL insulins. Conclusion: GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products. |
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| MeSH term(s) | Male ; Humans ; United States ; Insulin Glargine/adverse effects ; Insulin Lispro/therapeutic use ; Insulin ; Hypoglycemic Agents/therapeutic use ; Therapeutic Equivalency ; Biosimilar Pharmaceuticals/therapeutic use ; Blood Glucose ; Insulin, Regular, Human ; Cross-Over Studies ; Double-Blind Method ; Insulin Aspart/adverse effects |
| Chemical Substances | Insulin Glargine (2ZM8CX04RZ) ; Insulin Lispro ; Insulin ; fluchloralin (98UIF19AH9) ; Hypoglycemic Agents ; Biosimilar Pharmaceuticals ; Blood Glucose ; Insulin, Regular, Human ; Insulin Aspart (D933668QVX) |
| Language | English |
| Publishing date | 2023-09-21 |
| Publishing country | England |
| Document type | Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 1454944-x |
| ISSN | 1463-1326 ; 1462-8902 |
| ISSN (online) | 1463-1326 |
| ISSN | 1462-8902 |
| DOI | 10.1111/dom.15281 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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