Association of British Clinical Diabetologists (ABCD) position statement on the use of biosimilar insulin
Keywords:biosimilar insulin, safety, immunogenicity, switch
Biosimilar insulins have the potential to offer the NHS a considerable cost saving. The acceptability and use of biosimilar insulin by clinicians and patients may, however, be limited by lack of experience, understanding and concerns about safety and tolerability. This article summarises information on the advantages and disadvantages of using biosimilar insulins and an overview of the published evidence in relation to efficacy, tolerability and safety of current and expected Biosimilar Insulins. The position of the ABCD on the use of Biosimilar Insulin is stated along with the key practical considerations for healthcare staff involved in insulin prescription and administration.
Heinemann L, Hompesch M. Biosimilar insulins: basic considerations. J Diabetes Sci Technol 2014;8(1):6–13. https://doi.org/10.1177/1932296813516958
Johnson IS. Human insulin from recombinant DNA technology. Science 1983;219(4585):632–7. https://doi.org/10.1126/science.6337396
Llano A, Fisher M, McKay G. Biosimilar insulin: the current landscape. Pract Diabetes 2017;34(2):51–4. https://doi.org/10.1002/pdi.2079
Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf (accessed 24 Feb 2018).
NICE. Position Statement: Evaluating biosimilar medicines. January 2015. https://www.nice.org.uk/news/article/evaluating-biosimilar-medicines (accessed 24 Feb 2018).
Blevins TC, Dahl D, Rosenstock J, et al. Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. Diabetes Obes Metab 2015;17(8):726–33. https://doi.org/10.1111/dom.12496
Rosenstock J, Hollander P, Bhargava A, et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naive or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab 2015;17(8):734–41. https://doi.org/10.1111/dom.12482
European Medicines Agency. Summary of the European public assessment report (EPAR) for Lusduna. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004101/WC500219588.pdf (accessed 24 Feb 2018).
European Medicines Agency. Summary of the European public assessment report (EPAR) for Insulin Lispro Sanofi. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004303/WC500235297.pdf (accessed 24 Feb 2018).
Committee for Medicinal Products for Human Use (CHMP) Summary of opinion, Semglee. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004280/ WC500242403.pdf (accessed 24 Feb 2018).
NICE. Evidence summary: Diabetes mellitus type 1 and type 2: insulin glargine biosimilar (Abasaglar). Dec 2015. https://www.nice.org.uk/guidance/esnm64 (accessed 24 Feb 2018).
European Medicines Agency. Summary of the European public assessment report (EPAR) for Abasaglar. https://www.ema.europa.eu/documents/overview/abasaglar-previously-abasria-epar-summary-public_en.pdf (accessed 24 Feb 2018).
Publish & Transfer of Copyright Agreement
For the mutual benefit and protection of the Author and the Journal Owner/Publisher it is necessary that the Author provides formal written Consent to Publish and Transfer of Copyright before publication of the Work.