Comparison of two insulin glargine formulations: biosimilar vs. reference product

Biosimilar medicinal products have been in use in the European Union since 2006. In September 2014, insulin glargine (LY IGlar) was approved as a long-acting insulin analogue. In accordance with EMA (European Medicines Agency) and FDA (Food and Drug Administration) guidelines, analytical, preclinical and clinical studies were submitted demonstrating drug safety and biosimilarity of LY IGlar with the reference insulin glargine (IGlar). In a review article, study data collected in the clinical development of LY IGlar are summarized. A program of Phase 1 studies investigated whether the criteria for bioequivalence were met. Based on these standards, the pharmacokinetic and pharmacodynamic properties of the two insulins were shown to be similar. The clinical comparability of LY IGlar versus IGlar was demonstrated in two Phase 3 studies in patients with type 1 and type 2 diabetes. The tolerability profiles of LY IGlar and IGlar were similar in these studies; no significant differences were observed in the rate of adverse events, hypoglycemic events or immunogenicity. The results of these studies show that LY IGlar represents an alternative treatment option for basal insulin therapy in patients with type 1 and type 2 diabetes because its efficacy and tolerability is similar to that of IGlar.