Wei Chen, Jia Lu, Leona Plum-Mörschel, Grit Andersen, Eric Zijlstra, Anshun He, Tian Xie, Longling Li, Chunyue Hao, Zhongru Gan, Tim Heise
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)...
September 21, 2023: Diabetes, Obesity & Metabolism