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Subcutaneous MYL1501D insulin glargine 100 U/mL (hereafter referred to as MYL1501D insulin glargine) [Semglee ® ] is a long-acting human insulin analogue approved as a biosimilar of insulin glargine 100 U/mL (hereafter referred to as reference insulin glargine 100 U/mL) [Lantus ® ] in various countries, including those of the EU for the treatment of diabetes mellitus in patients aged ≥ 2 years, as well as Japan for diabetes where insulin therapy is indicated. MYL1501D insulin glargine has similar physicochemical characteristics and biological properties to those of EU- and US-sourced reference insulin glargine 100 U/mL, with the bioequivalence of pharmacodynamic and pharmacokinetic parameters between these agents shown in adults with type 1 diabetes. Once-daily MYL1501D insulin glargine demonstrated noninferior glycaemic efficacy to that of once-daily reference insulin glargine 100 U/mL in adults with type 1 or 2 diabetes, with its glycated haemoglobin-lowering benefits maintained over the longer-term (52 weeks) and unaffected by previous insulin exposure. Switching between MYL1501D insulin glargine and reference insulin glargine 100 U/mL did not appear to impact glycaemic efficacy in adults with type 1 diabetes. MYL1501D insulin glargine was well tolerated, demonstrating a safety and immunogenicity profile similar to that of reference insulin glargine 100 U/mL in patients with type 1 and 2 diabetes, and in those with type 1 diabetes switching between the two agents. As expected, hypoglycaemia was the most frequently reported treatment-emergent adverse event. Thus, MYL1501D insulin glargine provides an effective biosimilar alternative for patients requiring insulin glargine therapy.

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.