a Institute of Drug Discovery Technology , Ningbo University , Ningbo , China.
b Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College , Huazhong University of Science and Technology , Wuhan , China.
Expert Opin Biol Ther. 2018 Nov;18(11):1107-1112. doi: 10.1080/14712598.2018.1533548. Epub 2018 Oct 10.
The global incidence of diabetes mellitus is increasing, with a concomitant rise in individual and overall treatment costs. The development of biosimilars contributes to the facilitation of greater access to treatment. SAR342434 is a biosimilar follow-on of insulin lispro, a key therapeutic for the treatment of diabetes mellitus, and it is currently under phase III clinical trials. Areas covered: In this review we discuss the recent updates on clinical data obtained from phase III trials to compare the equivalence and similarity of SAR342434 to insulin lispro, including pharmacokinetics (PKs), pharmacodynamics, clinical efficacy, safety and immunogenicity. Expert opinion: The rising treatment costs of diabetes mellitus poses a challenge to public health enterprises worldwide. The development of biosimilars is probably a good choice to solve this conundrum. Based on the available clinical trials, it is confirmed that SAR342434 is equivalent to the reference insulin lispro, with similar pharmacodynamics, PKs, anti-hyperglycemic efficacy and safety. These attributes show the good potential of SAR342434 for serving as an alternative to achieve the glycemic control in patients with diabetes mellitus.
全球糖尿病发病率不断上升，导致个人和总体治疗成本相应增加。生物类似药的发展有助于更方便地获得治疗。SAR342434 是胰岛素赖脯肽的生物类似药，胰岛素赖脯肽是治疗糖尿病的关键药物，目前正在进行 III 期临床试验。
在这篇综述中，我们讨论了从 III 期临床试验中获得的最新临床数据，以比较 SAR342434 与胰岛素赖脯肽的等效性和相似性，包括药代动力学（PK）、药效学、临床疗效、安全性和免疫原性。
糖尿病治疗成本的不断上升给全球公共卫生企业带来了挑战。生物类似药的发展可能是解决这一难题的一个不错选择。基于现有的临床试验，证实 SAR342434 与参考胰岛素赖脯肽等效，具有相似的药效学、PK、抗高血糖疗效和安全性。这些特性表明 SAR342434 具有良好的潜力，可以替代胰岛素赖脯肽，实现糖尿病患者的血糖控制。
