Biosimilar insulins: What do you need to know?

Authors

  • June James
  • Robyn K. Pollom
  • Irene Hadjiyianni
  • Gabriele Buchholz
  • Beverly L. Reed

DOI:

https://doi.org/10.1080/20573316.2017.1340246

Keywords:

Biosimilar, Diabetes mellitus, Immunogenicity, Insulin, Insulin glargine, Diabetes specialist nurse, Biologics; Devices

Abstract

Biologics are large, complex molecules derived from living organisms and include hormones, such as insulin. Biologics possessing an identical amino acid structure, and similar efficacy and safety to an approved reference product are called biosimilars. The first biosimilar insulin was approved in the European Union in 2014 and more are expected to come to market. Patient education for biosimilar insulins is the same as for other insulins, but additional factors for patients changing their insulin should be considered. This article is a resource for healthcare professionals who treat patients with diabetes and support them in making important treatment decisions.

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References

Polimeni G, Trifirò G, Ingrasciotta Y, Caputi AP. The advent of biosimilars for the treatment of diabetes: current status and future directions. Acta Diabetol. 2015;52(3):423–31. doi: 10.1007/s00592-015-0771-7

Gilroy C, Luginbuhl KM, Chilkoti A. Controlled release of biologics for the treatment of type 2 diabetes. J Control Release. 2016;240:151–64. doi: 10.1016/j.jconrel.2015.12.002

European Medicines Agency. Guideline on similar biological medicinal products. 2014a. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. (accessed 30 Jan 2017).

Eli Lilly and Company Press Release. European Commission grants Lilly and Boehringer ingelheim’s insulin glargine product marketing authorization in Europe. 2014. Available from: http://lilly.mediaroom.com/index.php?s=9042&item=137348. (accessed 30 Jan 2017).

European Commission Consensus Information Paper. What you need to know about biosimilar medicinal products. 2013. Available from: http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/en/renditions/pdf. (accessed 30 Jan 2017).

Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411–19. doi: 10.1093/annonc/mdm345

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):989–96. doi: 10.1089/dia.2012.0105

Schellekens H. Biosimilar therapeutics – what do we need to consider? NDT Plus. 2009;2(Suppl 1):i27–i36. doi: 10.1093/ndtplus/sfn177

DeVries JH, Gough SC, Kiljanski J, Heinemann L. Biosimilar insulins: a European perspective. Diabetes Obes Metab. 2015;17(5):445–51. doi: 10.1111/dom.12410

Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1:1–11. doi: 10.2147/BS.S16120

European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2015a. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. (accessed 2 Sep 2016).

European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. 2015b. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184161.pdf. (accessed 1 Dec 2016).

Heinemann L, Home PD, Hompesch M. Biosimilar insulins: guidance for data interpretation by clinicians and users, diabetes. Obes Metab. 2015;17(10):911–18. doi: 10.1111/dom.12491

Tsuruta LR, Lopes dos Santos M, Moro AM. Biosimilars advancements: moving on to the future. Biotechnol Prog. 2015;31(5):1139–49. doi: 10.1002/btpr.2066

Heinemann L, Hompesch M. Biosimilar insulins: basic considerations. J Diabetes Sci Technol. 2014;8(1):6–13. doi: 10.1177/1932296813516958

Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov. 2002;1:457–62. doi: 10.1038/nrd818

Rovira J, Espin J, Garcia L, Olry de Labry A. The impact of biosimilars’ entry in the EU market. 2011. Available from: http://ec.europa.eu/DocsRoom/documents/7651/attachments/1/translations/en/renditions/pdf. (accessed 01 Feb 2017).

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;30:138–50. doi: 10.2337/diaclin.30.4.138

NHS England, Medical Directorate. What is a biosimilar medicine? 2015. Available from: https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf. (accessed 2 Feb 2017). doi:10.1089/dia.2014.0362.

Heinemann L, Khatami H, McKinnon R, Home P. An overview of current regulatory requirements for approval of biosimilar insulins. Diabetes Technol Ther. 2015;17(7):510–26. doi: 10.1089/dia.2014.0362

Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111–17. doi: 10.1182/blood-2012-04-425744

Association of the British Pharmaceutical Industry. ABPI position on biologic medicines, including biosimilar medicines. 2015. Available from: http://www.abpi.org.uk/our-work/library/Documents/ABPI%20position%20on%20biosimilar%20medicines.pdf#search=ABPI%2520position%2520on%2520biosimilar%2520medicines. (accessed 1 Feb 2017).

Diabetes UK. Position statement on biosimilar insulins. 2013. Available from: https://www.diabetes.org.uk/Documents/Position%20statements/diabetes-uk-position-statement-biosimilar-insulins-1013.pdf. (accessed 1 Feb 2017).

Primary Care Diabetes Society. Biosimilar insulin and safety. A statement from the PCDS, diabetes & primary care. 2015;17:222.

Declerck PJ. Biologicals and biosimilars: a review of the science and its implications. GaBI J. 2012;1:113–6. doi: 10.5639/gabij.2012.0101.005

Dowlat HA, Kuhlmann MK, Khatami H, Ampudia-Blasco FJ. Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications. Diabetes Obes Metab. 2016;18(8):737–46. doi: 10.1111/dom.12676

Dolinar RO, Edelman S, Heinemann L, Home P, Goyal S, Polonsky WH, et al. Impact of biosimilar insulins on clinical practice: meeting report. J Diabetes Sci Technol. 2014;8:179–85. doi: 10.1177/1932296813518267

European Medicines Agency. EMA procedural advice for users of the centralised procedure for similar biological medicinal products applications. 2015c. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125166.pdf. (accessed 1 Feb 2017).

European Medicines Agency. Lantus: insulin glargine. 2015d. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000284/human_med_000882.jsp&mid=WC0b01ac058001d124. (accessed 1 Feb 2017).

European Medicines Agency. Abasaglar (previously Abasria) insulin glargine. 2015e. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002835/human_med_001790.jsp&mid=WC0b01ac058001d124. (accessed 1 Feb 2017).

European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). 2014b. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf. (accessed 30 Jan 2017).

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Published

2017-01-02

How to Cite

James, J., Pollom, R. K., Hadjiyianni, I., Buchholz, G., & Reed, B. L. (2017). Biosimilar insulins: What do you need to know?. International Diabetes Nursing, 14(1), 32–35. https://doi.org/10.1080/20573316.2017.1340246

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Section

Review