GregoryGA, RobinsonTIG, LinklaterSE, et al.Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol, 2022; 10: 741–760.
2.
MulcahyAW, SchwamD, EdenfieldN. Comparing Insulin Prices in the United States Compared to Other Countries: Results from a Price Index Analysis. Santa Moncia, CA: RAND Corporation; 2020. www.rand.org/pubs/research_reports/RRA788-1.html.
3.
HirschIB.Insulin pricing in the USA: the saga continues. Lancet Diabetes Endocrinol, 2022; 10: 695.
RosenstockJ, BainSC, GowdaA, et al.Weekly icodec versus daily glargine U100 in type 2 diabetes without previous insulin. N Engl J Med, 2023; 389: 297–308.
6.
LingvayI, AsongM, DesouzaC, et al.Once-weekly insulin icodec vs once-daily insulin degludec in adults with insulin-naive type 2 diabetes: the ONWARDS 3 randomized clinical trial. JAMA, 2023; 330: 228–237.
7.
FriasJ, ChienJ, ZhangQ, et al.Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study. Lancet Diabetes Endocrinol, 2023; 11: 158–168.
8.
HoltRIG, DeVriesJH, Hess-FischlA, et al.The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care, 2021; 44: 2589–2625.
9.
SherrJL, SchoelwerM, Dos SantosTJ, et al.ISPAD clinical practice consensus guidelines 2022: diabetes technologies: insulin delivery. Pediatr Diabetes, 2022; 23: 1406–1431.
10.
KjeldsenTB, HubalekF, HjorringgaardCU, et al.Molecular engineering of insulin icodec, the first acylated insulin analog for once-weekly administration in humans. J Med Chem, 2021; 64: 8942–8950.
11.
Plum-MorschelL, AndersenLR, HansenS, et al.Pharmacokinetic and pharmacodynamic characteristics of insulin icodec after subcutaneous administration in the thigh, abdomen or upper arm in individuals with type 2 diabetes mellitus. Clin Drug Investig, 2023; 43: 119–127.
12.
Philis-TsimikasA, BajajHS, BegtrupK, et al.Rationale and design of the phase 3a development programme (ONWARDS 1–6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab, 2023; 25: 331–341.
13.
Philis-TsimikasA, AsongM, FranekE, et al.Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol, 2023; 11: 414–425.
14.
MathieuC, AsbjornsdottirB, BajajHS, et al.Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet, 2023; 401: 1929–1940.
15.
MoyersJS, HansenRJ, DayJW, et al.Preclinical characterization of LY3209590, a novel weekly basal insulin Fc-fusion protein. J Pharmacol Exp Ther, 2022; 382: 346–355.
16.
HeiseT, ChienJ, BealsJM, et al.Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once-weekly dosing for the treatment of patients with diabetes. Diabetes Obes Metab, 2023; 25: 1080–1090.
17.
Bue-ValleskeyJM, KazdaCM, MaC, et al.Once-weekly basal insulin Fc demonstrated similar glycemic control to once-daily insulin degludec in insulin-naive patients with type 2 diabetes: a phase 2 randomized control trial. Diabetes Care, 2023; 46: 1060–1067.
18.
KazdaCM, Bue-ValleskeyJM, ChienJ, et al.Novel once-weekly basal insulin Fc achieved similar glycemic control with a safety profile comparable to insulin degludec in patients with type 1 diabetes. Diabetes Care, 2023; 46: 1052–1059.
19.
HeinemannL, DaviesM, HomeP, ForstT, VilsbøllT, SchnellO.Understanding biosimilar insulins: development, manufacturing, and clinical trials. J Diabetes Sci Technol. Published online July 11, 2022. doi: 10.1177/19322968221105864.
20.
HomeP.Insulin biobetters and biosimilars in clinical practice. J R Coll Physicians Edinb, 2023; 53: 147–155.
21.
HellerS, RaposoJF, TofeS, et al.Breaking barriers with basal insulin biosimilars in type 2 diabetes. Clin Diabetes, 2023; 41: 154–162.
22.
VishwakarmaG, NupurN, RathoreAS.Assessing the structural and functional similarity of insulin glargine biosimilars. J Diabetes Sci Technol, 2023; 17: 417–427.
23.
MouslimMC, RashidiES, LevyJF, SocalMP, TrujilloAJ.The price paradox of biosimilar-like long-acting insulin. Am J Manag Care, 2022; 28: e405–e410.
24.
LuukkanenSV, TolonenHM, AiraksinenM, SaarukkaLSM.The price and market share evolution of the original biologics and their biosimilars in Finland. BioDrugs, 2022; 36: 537–547.
JoshiSR, MittraS, RajP, SuvarnaVR, AthalyeSN.Biosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know. Insulins perspective. Expert Opin Biol Ther. Published online August 21, 2022. doi: 10.1080/14712598.2022.2112664.
27.
VaidyanathanJ, WangYC, TranD, SeoSK.Leveraging clinical pharmacology data to assess biosimilarity and interchangeability of insulin products. Clin Pharmacol Ther, 2023; 113: 794–802.
28.
DraiRV, MayorovAY, KaronovaTL, et al.The efficacy and safety of GP40081 (insulin aspart biphasic 30) compared with NovoMix 30 in type 2 diabetes patients. J Comp Eff Res, 2022; 11: 1337–1347.
29.
BlevinsTC, RaiterY, SunB, et al.Immunogenicity, efficacy, and safety of biosimilar insulin aspart (MYL-1601D) compared with originator insulin aspart (Novolog) in patients with type 1 diabetes after 24 weeks: a randomized open-label study. BioDrugs, 2022; 36: 761–772.
30.
AndersenG, SinghG, MurugesanSMN, et al.Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar insulin N with US-licensed Humulin N formulation in healthy subjects: results from the RHINE-2 (Recombinant Human INsulin Equivalence-2) study. Diabetes Obes Metab, 2023; 25: 1485–1494.
31.
AlRuthiaY, BahariOH, Alghnam SA, et al.Real-world impact of switching from insulin glargine (Lantus) to Basaglar and potential cost saving in a large public healthcare system in Saudi Arabia. Front Public Health, 2022; 10: 852721.
32.
MohnickeM, BlecherA, BeichertK, et al.In vitro stability of biosimilar insulin aspart SAR341402 in the Medtronic MiniMed insulin pumps. J Pharm Sci, 2023; 112: 963–973.
33.
MohanV, SchmiderW, SinghKP, RotthaeuserB, MukherjeeB, AravindSR.Pharmacokinetic similarity between biosimilar insulin aspart premix SAR341402 mix 70/30 and originator insulin aspart mix 70/30 (NovoMix 30) in Indian adults with type 2 diabetes: GEMELLI M substudy. Indian J Endocrinol Metab, 2022; 26: 354–361.
34.
WangY, ZhouY, DingJ, et al.Pharmacokinetic and pharmacodynamic similarity evaluation between an insulin glargine biosimilar product and Lantus in healthy subjects: pharmacokinetic parameters of both parent insulin glargine and M1 were used as endpoints. Front Pharmacol, 2022; 13: 962201.
35.
CengizE, DanneT, AhmadT, et al.ISPAD clinical practice consensus guidelines 2022: insulin treatment in children and adolescents with diabetes. Pediatr Diabetes, 2022; 23: 1277–1296.
36.
McCallAL, LiebDC, GianchandaniR, et al.Management of individuals with diabetes at high risk for hypoglycemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab, 2023; 108: 529–562.
37.
LindM, CatrinaSB, EkbergNR, et al.Fast-acting insulin aspart in patients with type 1 diabetes in real-world clinical practice: a noninterventional, retrospective chart and database study. Diabetes Ther, 2023; 14: 1563–1575.
38.
SvehlikovaE, MursicI, AugustinT, et al.Pharmacokinetics and pharmacodynamics of three different formulations of insulin aspart: a randomized, double-blind, crossover study in men with type 1 diabetes. Diabetes Care, 2021; 44: 448–455.
39.
SvehlikovaE, AshcroftNL, GatschelhoferC, et al.Pharmacokinetics and pharmacodynamics of a novel U500 insulin aspart formulation: a randomized, double-blind, crossover study in people with type 1 diabetes. Diabetes Care, 2023; 46: 757–764.
40.
DiazJL, ColmegnaP, BretonMD.Maximizing glycemic benefits of using faster insulin formulations in type 1 diabetes: in silico analysis under open- and closed-loop conditions. Diabetes Technol Ther, 2023; 25: 219–230.
41.
IgnautD, FukudaT, BandiR, et al.An investigation into local infusion site pain after infusion of ultra rapid lispro excipients across sites and depths. J Diabetes Sci Technol. Published online November 3, 2022. doi: 10.1177/19322968221135217.
42.
WadwaRP, LaffelLM, FrancoDR, et al.Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: the PRONTO-Peds trial. Diabetes Obes Metab, 2023; 25: 89–97.
43.
AronsonR, BiesterT, LeohrJ, et al.Ultra rapid lispro showed greater reduction in postprandial glucose versus Humalog in children, adolescents and adults with type 1 diabetes mellitus. Diabetes Obes Metab, 2023; 25: 1964–1972.
44.
StamatiA, KaragiannisT, TsapasA, ChristoforidisA.Efficacy and safety of ultra-rapid insulin analogues in insulin pumps in patients with type 1 diabetes mellitus: a systematic review and meta-analysis. Diabetes Res Clin Pract, 2022; 193: 110144.
45.
DovcK, BergfordS, Fröhlich-ReitererE, et al.A comparison of faster insulin aspart to standard insulin aspart using hybrid automated insulin delivery system in active children and adolescents with type 1 diabetes: a randomized, double-blind crossover trial. Diabetes Technol Ther, 2023; 25: 612–621.
46.
WareJ, AllenJM, BoughtonCK, et al.Hybrid closed-loop with faster insulin aspart compared with standard insulin aspart in very young children with type 1 diabetes: a double-blind, multicenter, randomized, crossover study. Diabetes Technol Ther, 2023; 25: 431–436.
47.
ThabitH, MubitaW, RubioJ, et al.Comparison of faster-acting aspart with insulin aspart under conditions mimicking underestimation or missed meal boluses in type 1 diabetes using closed-loop insulin delivery. Diabetes Obes Metab, 2023; 25: 1121–1124.
48.
LachalS, TourkiY, FrancS, et al.Hybrid closed-loop control with ultrarapid lispro compared with standard insulin aspart and faster insulin aspart: an in silico study. J Diabetes Sci Technol, 2023; 17: 176–185.
49.
ColmegnaP, DiazJL, Garcia-TiradoJ, et al.Adjusting therapy profiles when switching to ultra-rapid lispro in an advanced hybrid closed-loop system: an in silico study. J Diabetes Sci Technol. Published online November 24, 2022. doi: 10.1177/19322968221140401.
50.
BaileyTS, BodeBW, WangQ, KnightsAW, ChangAM.Increased time in range with ultra rapid lispro treatment in participants with type 2 diabetes: PRONTO-Time in Range. Diabetes Ther, 2023; 14: 883–897.
51.
ZhangQ, ChigutsaF, ChangAM.Efficacy and safety of ultra-rapid lispro in younger and older patients with type 2 diabetes: randomized double-blind PRONTO-T2D study. Diabetes Ther, 2022; 13: 1547–1557.
52.
LebovitzHE, FlemingA, CherringtonAD, et al.Efficacy and safety of Tregopil, a novel, ultra-rapid acting oral prandial insulin analog, as part of a basal-bolus regimen in type 2 diabetes: a randomized, active-controlled phase 2/3 study. Expert Opin Pharmacother, 2022; 23: 1855–1863.
53.
KhadriaA, PaavolaCD, MaslovK, et al.Photoacoustic imaging reveals mechanisms of rapid-acting insulin formulations dynamics at the injection site. Mol Metab, 2022; 62: 101522.
