Biosimilars of aspart and lispro analogues in the insulin pump

E.N. Saverskaya¹, T.E. Eltysheva², D.S. Karpov², M.P. Korobkina², P.G. Zaikin²

¹Moscow State University of Food Production, Moscow

²Pharm-Holding CJSC, St. Petersburg

Background: insulin biosimilars hold a firm place in the treatment of patients with diabetes mellitus who need insulin therapy. The requirements for conducting trial confirming the biosimilar bioequivalence at the preclinical and clinical stages are regulated, which improves the biosimilar quality. Of particular interest is the use of biosimilar insulin analogues in the insulin pump.

Aim: to assess the stability of the produced substances (insulin biosimilars) according to the following indicators: quantitative determination, impurity content, pH level, as well as the dosing accuracy, and the tendency to catheter occlusion when used in insulin pumps.

Patients and Methods: aspart (RinFast^®) and lispro (RinLis^®) biosimilars were studied using the following pumps: MiniMed^TM 640G, MiniMed Paradigm REAL-Time (with continuous glucose monitoring) and Accu-Chek^® Combo. Studies on the dosing accuracy and the tendency to catheter occlusion were conducted using gravimetric analysis for 72 hours. Quantitative content analysis of insulin, related impurities and those exceeding the molecular weight of lispro was conducted with liquid chromatography for 72 hours at five points.

Results: the study demonstrated the stability of the substances produced by such indicators as quantitative determination, impurity content and pH level. The dosing accuracy of the used insulin pumps with both drugs corresponded to the initial dosing accuracy stated by the manufacturer. During the test, there was no occlusion signal, i.e. there was no tendency to catheter occlusion for 72 hours, which is equal to the recommended interval for infusion line replacement.

Conclusion: the stability of substances proven in these studies allows the use of RinFast^® and RinLis^® in insulin pumps.

Keywords: biosimilars, lispro, aspart, pump, occlusion, flash monitoring, insulin therapy.

For citation: Saverskaya E.N., Eltysheva T.E., Karpov D.S. et al. Biosimilars of aspart and lispro analogues in the insulin pump. RMJ. 2022;1:9–14.