LY2963016 Insulin Glargine: A Review in Type 1 and 2 Diabetes.

Subcutaneous once-daily LY2963016 insulin glargine (LY insulin glargine) [Abasaglar® (EU); Basaglar® (USA)] has been approved in the EU as a biosimilar to reference insulin glargine (Lantus®), and in the USA as a follow-on biologic to reference insulin glargine, for use in patients with type 1 or 2 diabetes. Structural and functional characterization of LY insulin glargine in preclinical studies showed that it is similar to reference insulin glargine. In phase I euglycaemic clamp studies, LY insulin glargine demonstrated similar pharmacodynamic (including duration of action) and pharmacokinetic parameters to reference insulin glargine. In the phase III ELEMENT trials, LY insulin glargine and reference insulin glargine were noninferior to each other with respect to glycaemic control, indicating their equivalent efficacy, when administered with mealtime insulin in adults with type 1 diabetes or with oral antiglycaemic medications in adults with type 2 diabetes. LY insulin glargine was generally well tolerated, with a safety profile (including the risk of hypoglycaemia and immunogenicity) similar to that of reference insulin glargine and without any additional safety concerns identified. Basal insulin treatment status at baseline did not impact the relative efficacy, safety and immunogenicity of LY insulin glargine versus reference insulin glargine in the ELEMENT 1 and 2 trials. In conclusion, LY insulin glargine offers an additional basal insulin option for patients with type 1 or 2 diabetes, potentially at a lower cost.