MarsoSM, McGuireDK, ZinmanB, et al.Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med, 2017; 377: 723–732.
2.
HeiseT, NørskovM, NosekL, et al.Insulin degludec: lower day-to-day and within-day variability in pharmacodynamics response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab, 2017; 19: 1032–1039.
3.
MonnierL, ColletteC. Pharmacological variability of insulin degludec and glargine 300U/mL: equivalent or not?. Diabetes Metab, 2018; 44: 15–21
4.
BeckerRHA. Letter to the editor in response to Heise T, Nørskov M, Nosek L, et al. Insulin degludec: lower day-to-day and within-day variability in pharmacodynamics response compared with insulin glargine 300 U/mL in type 1 diabetes (Diabetes Obes Metab 2017; 19: 1032–1039). Diabetes Obes Metab, 2018; 20: 2043–2047.
5.
HeiseT, KaplanK, HaahrHL. Day-to-day and within-day variability in glucose-lowering effect between insulin degludec and insulin glargine (100 U/mL and 300 U/mL): a comparison across studies. Diabetes Sci Technol, 2018; 12: 356–363.
6.
HeiseT, HeckermannS, DeVriesJH. Variability of insulin degludec and glargine 300 U/mL: a matter of methodology or just marketing?. Diabetes Obes Metab, 2018; 20: 2051–2056.
7.
ChengAYY, RosenstockJ, RitzelR, et al.Similar glycemic control and less comparable hypoglycemia with insulin glargine 300 U/mL (Gla-300) vs degludec 100 U/mL (IDeg-100) in insulin-naïve T2DM on antihyperglycemic drugs ± GLP-1 RAs – the BRIGHT randomized study. Diabetes, 2018; 67(Suppl 1): 301-OR.
8.
ZhangX, LamECQ, SegerME, et al.LY2963016 insulin glargine and insulin glargine (lantus) produce comparable pharmacokinetics and pharmacodynamics at two dose levels. Clin Pharmacol Drug Dev, 2017; 6: 556–56
9.
CrutchlowMF, PalczaJS, MostollerKM, et al.Single-dose euglycaemic clamp studies demonstrating pharmacokinetic and pharmacodynamic similarity between MK-1293 insulin glargine and originator insulin glargine (Lantus) in subjects with type 1 diabetes and healthy subjects. Diabetes Obes Metab, 2018; 20: 400–408.
10.
OwensDR, LandgrafW, SchmidtA, et al.The emergence of biosimilar insulin preparations—a cause for concern?. Diabetes Technol Ther, 2012; 14: 989–996.
11.
CarterAW, HeinemannL, KlonoffDC. Quality control of insulins and biosimilar insulins: what do we know?. J Diabetes Sci Technol, 2016; 10: 811–815.
12.
CarterAW, HeinemannL. Insulin concentration in vials randomly purchased in pharmacies in the United States: considerable loss in the cold supply chain. J Diabetes Sci Technol, 2018; 12: 839–841.
13.
DowlatHA, KuhlmannMK, KhatamiH, et al.Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications. Diabetes Obes Metab, 2016; 18: 737–746.
14.
HeinemannL, FritzI, KhatamiH, EdelmanSV. Administration of biosimilar insulin analogs: role of devices. Diabetes Technol Ther, 2017; 19: 79–84.
15.
DaviesM, DahlD, HeiseT, et al.Introduction of biosimilar insulins in Europe. Diabet Med, 2017; 34: 1340–1353.
16.
TieuC, LucasEJ, DePaolaM, et al.Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review. PLoS One, 2018; 13: e0195012.
17.
YamadaT, KamataR, IshinohachiK, et al.Biosimilar vs originator insulins: Systematic review and meta-analysis. Diabetes. Obes Metab, 2018; 20: 1787–1792.
18.
GargSK, Wernicke-PantenK, RojeskiMet al.Efficacy and safety of biosimilar SAR342434 insulin lispro in adults with type 1 diabetes also using insulin glargine-SORELLA 1 study. Diabetes Technol Ther, 2017; 19: 516–526.
19.
HamptonT. Smart artificial beta cells may help treat diabetes. JAMA, 2018; 319: 11–12.
20.
Safety alert: change of colour for fast-acting insulin Fiasp products. Drug Ther Bull, 2018; 56: 62–63.
