Equivalence on Efficacy and Safety of Two Formulations of Insulin Glargine (Biosimilar and Reference) in the Treatment of Patients with Type 2 Diabetes Mellitus
Clinical Medicine Research
Volume 3, Issue 2, March 2014, Pages: 50-55
Received: Mar. 14, 2014; Accepted: Apr. 9, 2014; Published: Apr. 20, 2014
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Hernandez-Bastida, Antonio, Nuevo Hospital Obregon, Mexico City, Mexico
Meixueiro-Montes de Oca, Raúl, Laboratorios PiSA, Mexico City, Mexico
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Use of biosimilars has allowed the access to biopharmaceuticals to a more patients in the World. Insulin galrgine is an analogue of human insulin to provide consistent level of plasma insulin over a long duration. The aim of this study was compare the safety and efficacy of insulin glargine biosimilar vs reference in individuals with type 2 diabetes. One hundred two type 2 diabetic individuals (64 female and 38 male) were studied in a single center, randomized, comparative study. The patients received during 12 weeks insulin glargine biocomparable or reference at doses of 0.4 to 0.7 IU/kg/day by subcutaneous via. Glycosylated hemoglobin (Hb1Ac), Fasting blood glucose (FBG), and lipid profile were evaluated during the study. Health-related quality of life was evaluated using the 36-item Short Form questionnaire. Hb1Ac, FBG and lipid profile improved significantly from to start to endpoint in both groups. No significant differences were found between both groups. A total of 80.8 and 77.2% of patients had HbA1c < 7.5% and 66,6% and 69.5% achieved the FBG target, for reference and biosimilar insulin glargine, respectively. No significant reductions in body weight were observed between the start and the end of the study. The adverse event more reported was hypoglycemia. There was no apparent association between the levels of cross-reacting antibodies and Hb1Ac, body weight, insulin dose, or hypoglycemic episodes Improvements in both mental and physical health status were found, but no differences significant were found between the groups. We conclude that insulin galrgine biocomparable was similar since the safety and efficacy point of view with insulin glargine of reference in patients with diabetes mellitus 2
Type 2 Diabetes Mellitus, Biosimilar, Insulin Glargine, Efficacy, Safety
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Hernandez-Bastida, Antonio, Meixueiro-Montes de Oca, Raúl, Equivalence on Efficacy and Safety of Two Formulations of Insulin Glargine (Biosimilar and Reference) in the Treatment of Patients with Type 2 Diabetes Mellitus, Clinical Medicine Research. Vol. 3, No. 2, 2014, pp. 50-55. doi: 10.11648/j.cmr.20140302.19
Woodcock J, Griffin J, Behrman R, et al. The FDAs assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov 2007; 6: 437-442.
Crommelin DJ, Bermejo T, Bissig M, et al. Pharmaceutical evaluation of biosimilars : important differences from generic low-molecular weight pharm. Eur J Hosp Pharm Sci 2005; 1: 11-17
Roger SD. Biosimilars: how similar or dissimilars are they? Nephrology 2006; 11: 341-346.
Schellekenes H. Follow-on biologics: challenges of the “next generation”. Nephrol Dial Transplant 2005; 20: 31-36.
Shalet SM, Toogood A, Rahim A, et al. The diagnosis of growth hormone deficiency in children and adults. Endocr Rev 1998; 19: 203-223.
WHO. Guidelines on evaluation of similar biotherapeutics products. Expert Committee on Biological Standarization. Geneva 10 to 23 october 2009.
Mellstendt H, Niederweisser D, Ludwing H. The challenge of biosimilars. Ann Oncol 2008; 19(3): 411-419.
European Medicines Agency. Guideline on Similar Biological Medicinal Products. 2006. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517-pdf, Accessed December 6, 2010.
Roger SD, Goldsmith D. Biosimilars: it´s not as simple as costs alone. J Clin Pharm Ther 2008; 33(5): 459-464.
Stewart A, Aubrey P, Belsey J. Addressing the health technology assessment of biosimilar pharmaceuticals. Curr Med Res Opin 2010; 26(9): 2119-2126.
Heinemann L, Hompesch M. Biosimilar insulins: How similar is similar? J Diabetes Sci & Tech 2011; 5(3): 741-754.
Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002; 1: 457-462.
Schellekens H. The first biosimlar epoetin: but how similar is it? Clin J Am Soc Nephrol 2008; 3: 174-178.
Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Råstam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care 2002;25: 876–882
Mire-Sluis AR, Barrett YC, Devanarayan V, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 2004;289: 1–16
Roger SD. Biosimilars: how similar or dissimilars are they? Nephrology 2006; 11: 341-346. Igula al 13 de arriba
Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 2004; 22: 1383-1391
Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant 2006; 21 (suppl 5): v9-v12.
Pennartz C, Schenker N, Menge Ba, et al. Chronic reduction of fasting glycemia with insulin glargine improves first- and second-phase insulin secretion in patients with type 2 diabetes. Diabetes Care 2011; 34(9): 2048-2053.
Bergenstal RM, Rosenstock J, Arakaki RF, et al. A randomized, controlled study of once daily LY-2605541, a novel long-acting insulin, versus insulin glargine in basal insulin-treated patients with type 2 diabetes. Diabetes Care 2012; 35(11): 2140-2147.
Forst T, Larbig M, Hohberg C, et al. Adding insulin glargine vs NPH insulin to metformin results in a more efficient postprandial beta-cell protection in individulas with type 2 diabetes. Diabetes Obes Metab 2010; 12(5): 437-441.
Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. Diabetes Care 2009; 32(1): 193-203.
Rosenstock J, Schwartz SL, Clark CM Jr, Park GD, Donley DW, Edwards MB. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care. 2001;24:631–636.
Massi Benedetti MM, Humburg E, Dressler A, Ziemen M. A one-year, randomized, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Horm Metab Res. 2003; 35: 189–196.
Kacerovsky-Bielesz G, Dressler A, Freunscht R. Long-term glycemic control with insulin glargine in type 2 diabetes. Diabetes Res Clin Pract. 2006;71:184–191.
Heise T, Tack CJ, Cuddihy R, et al. A new generation ultra-long-acting basal insulin with a bolous boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care 2011; 34: 669-674.
Hatman I. Insulin analogs: impact on treatment success, satisfaction, quality of life, and adherence. Clin Metab Res 2008; 6: 54-67.
Hajos TR, Pouwer F, de Grooth R, et al. Initiation of insulin glargine in patients with type 2 diabetes in suboptimal glycaemic control positively impacts health-related quality of life. A prospective cohort study in primary care. Diabet Med 2011; 28 (9): 1096-1102.
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