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Postgraduate Medicine Volume 126, 2014 - Issue 3
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Clinical Focus: Diabetes and Concomitant Disorders

Biosimilar Insulins Are Coming: The Top 10 Things you Should Know

Ian Blumer Charles H. Best Diabetes Centre, Whitby, Ontario, CanadaCorrespondence[email protected]
, MD &
Steven Edelman University of California-San Diego, San Diego, CA
, MD
Pages 107-110 | Published online: 13 Mar 2015

References

  • . Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411–419
  • . Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1:1–11
  • . Home P. Biosimilar insulins. Diabetes Voice. 2011;56(2):40–43
  • . Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014;103(2):137–149
  • . Owens DR, Landgraf W, Schmidt A, Bretzel RG, Kuhlmann MK. The emergence of biosimilar insulin preparations—a cause for concern? Diabetes Technol Ther. 2012;14(11):989–996
  • . Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus. 2009;2( Suppl 1):i27–i36
  • . Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology (Carlton). 2006;11(4):341–346
  • . Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28(6):1053–1058
  • . Gough S. Biosimilar insulins: opportunities and challenges. Pract Diabetes. 2013;30(4):146–147a
  • . Krämer I, Sauer T. The new world of biosimilars: what diabetologists need to know about biosimilar insulins. Br J Diabetes Vasc Dis. 2010;10(4):163–171
  • . Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res. 2007;30(5):267–272
  • . European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/12/WC500136392.pdf. Accessed March 25, 2014
  • . Kuhlmann M, Marre M. Lessons learned from biosimilar epoetins and insulins. Br J Diabetes Vasc Dis. 2010;10(2):90–97
  • . MacDougall IC. Pure red cell aplasia with anti-erythropoietin antibodies occurs more commonly with one formulation of epoetin alfa than another. Curr Med Res Opin. 2004;20(1):83–86
  • . Roger SD, Mikhail A. Biosimilars: opportunity or cause for concern? J Pharm Pharm Sci. 2007;10(3):405–410
  • . Friedrichs A, Bohnet J, Korger V, Adler S, Schubert-Zsilavecz M, Abdel-Tawab M. Dose accuracy and injection force of different insulin glargine pens. J Diabetes Sci Technol. 2013;7(5):1346–1353
  • . Rotenstein LS, Ran N, Shivers JP, Yarchoan M, Close KL. Opportunities and challenges for biosimilars: what's on the horizon in the global insulin market? Clin Diabetes. 2012;30(4):138–150
  • . Strojek K, Tarasiuk A, Bijoś P, Czech A. Gensulin M30 in patients with type 2 diabetes and secondary failure to oral antidiabetic drugs. The Progens-first-step study: a multicentre observational study in the outpatient setting [article in Polish]. Diabet Dośw Klin. 2008;8(4):173–178
  • . Grzeszczak W, Bijoś P, Borkowski M, Manikowski A. A comparison of the efficacy and safety in patients with type 2 diabetes mellitus managed with premixed human insulin (Gensulin M30) versus pre-mixed insulin aspart 30/70 (NovoMix 30) [article in Polish]. Diabet Dośw Klin. 2010;10(1):53–59
  • . Segal D, Tupy D, Distiller L. The Biosulin Equivalence in Standard Therapy (BEST) study—a multicentre, open-label, non-randomised, interventional, observational study in subjects using Biosulin 30/70 for the treatment of insulin-dependent type 1 and type 2 diabetes mellitus. S Afr Med J. 2013;103(7):458–460
  • . Zhu LQ, He LJ, Gu QK. A study on the control of fasting and postprandial hyperglycemia by glargine insulin combined with oral hypoglycemic agent [article in Chinese]. Chin J Diabetes. 2009;17(9):690–692. English translation published in J Pak Med Assoc. 2013;63(Suppl 12). http://www.jpma.org.pk/PdfDownload/supplement_131.pdf. Accessed March 25, 2014
  • . Cheng SW, Lu JM, Pang CY. Studies of pharmacokinetic, pharmacodynamic properties and bioequivalence of recombinant insulin glargine injection in healthy man [article in Chinese]. Chin J Diabetes. 2010;18(5):387–393. English translation published in J Pak Med Assoc. 2013;63(Suppl 12). http://www.jpma.org.pk/PdfDownload/supplement_132.pdf. Accessed March 25, 2014
  • . Verma M, Hazra P, Iyer H, . Basalog® is similar to Lantus® in producing glycemic control in patients with type 1 diabetes mellitus on multiple daily insulin regimens. Int J Diabetes Dev Ctries. 2011;31(1):26–31
  • . US Department of Health and Human Services. US Food and Drug Administration. Biosimilars. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm. Accessed March 25, 2014
  • . Eli Lilly and Company; Boehringer Ingelheim. Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product. https://investor.lilly.com/releasedetail.cfm?releaseid=815459. Accessed March 25, 2014
  • . Aapro M, Cornes P, Sun D, Abraham I. Comparative cost efficiency across the European G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in patients with cancer. Ther Adv Med Oncol. 2012;4(3):95–105

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