Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
BioDrugs. 2020 Apr;34(2):245-251. doi: 10.1007/s40259-020-00418-x.
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.
皮下注射 MYL1501D 胰岛素甘精 100U/mL（以下简称 MYL1501D 胰岛素甘精）[Semglee]是一种长效人胰岛素类似物，已在包括欧盟在内的多个国家获得批准，作为胰岛素甘精 100U/mL（以下简称参考胰岛素甘精 100U/mL）[Lantus]的生物类似药，用于治疗年龄≥2 岁的糖尿病患者，以及日本的胰岛素治疗适应证的糖尿病患者。MYL1501D 胰岛素甘精与人源胰岛素甘精 100U/mL 具有相似的理化特性和生物学特性，在 1 型糖尿病成人中，这些药物的药效动力学和药代动力学参数具有生物等效性。在 1 型或 2 型糖尿病成人中，每日一次的 MYL1501D 胰岛素甘精与每日一次的参考胰岛素甘精 100U/mL 相比，具有非劣效的血糖疗效，并且其降低糖化血红蛋白的益处可长期维持（52 周），不受先前胰岛素暴露的影响。在 1 型糖尿病成人中，从 MYL1501D 胰岛素甘精转换为参考胰岛素甘精 100U/mL 似乎不会影响血糖疗效。MYL1501D 胰岛素甘精具有良好的耐受性，在 1 型和 2 型糖尿病患者以及从两种药物中转换的 1 型糖尿病患者中，其安全性和免疫原性与参考胰岛素甘精 100U/mL 相似。与预期一致，低血糖是报告最频繁的治疗相关不良事件。因此，MYL1501D 胰岛素甘精为需要胰岛素甘精治疗的患者提供了一种有效的生物类似药替代方案。
