Clinical and Biochemical Evaluation of L2963016: A Comprehensive Study of Insulin Glargine Biosimilarity to Lantus®

The first biosimilar insulin LY2963016 insulin glargine (Abasaglar) received regulatory approval in Europe, marking a significant step as biosimilar insulin products enter the market. Given that insulin products are complex biological agents produced through intricate biotechnological processes, they are not identical to their reference products. This article reviews a series of experiments to compare the bioequivalence of LY2963016 insulin glargine (LY IGlar) and reference insulin glargine (Lantus, IGlar) in patients with type 1 or type 2 diabetes, assessing structure, pharmacokinetics, efficacy and safety, and duration of action. Additionally, their immunogenicity profiles and their potential impact on clinical outcomes were were examined, demonstrating comparable outcomes between LY IGlar and IGlar in terms of bioequivalence and immunogenicity.