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Review Diabetes Recombinant Human Insulin in Global Diabetes Management – Focus on Clinical Efficacy Jean Claude Mbanya, 1 Juergen Sandow, 2 Wolfgang Landgraf 3 and David R Owens 4 1. University of Yaoundé I, Cameroon and Endocrinology and Metabolic Diseases Unit at the Hospital Central in Yaoundé, Cameroon; 2. Centre of Pharmacology, Johann-Wolfgang-Goethe University, Frankfurt/Main, Germany; 3. Medical Affairs Diabetes Division, Sanofi-Aventis Frankfurt, Germany; 4. Diabetes Research Group, College of Medicine, University of Swansea, Wales, UK B iosynthetic human insulin and insulin analogues are the mainstay of insulin therapy for both type 1 and type 2 diabetes although access to human insulin at affordable prices remains a global issue. The world is experiencing an exponential rise in the prevalence of diabetes presenting an urgent need to establish effective diabetes therapy in countries burdened by inadequate health care budgets, malnutrition and infectious diseases. Recombinant human insulin has replaced animal insulins and animal-based semisynthetic human insulin thereby available in sufficient quantities and at affordable prices able to provide global access to insulin therapy. In many patients, analog insulins can offer additional clinical benefit, although at a considerably higher price thus severely restricting availability in low income countries. The approval process for recombinant human insulins (i.e. biosimilars) and analogue insulins is highly variable in the developing countries in contrast to Europe and in North America, where it is well established within a strict regulatory framework. This review aims to discuss the future access to human insulin therapy in a global context with an ever increasing burden of diabetes and significant economic implications. Keywords Diabetes mellitus, biosynthetic human insulin, biosimilar and analogue insulins, regulatory requirements, cost, global access Disclosure: Jean Claude Mbanya is member of the Sanofi AMESA Diabetes Advisory Board. Juergen Sandow is a consultant to Sanofi Paris and Academic Research Associate. Wolfgang Landgraf is an employee of Sanofi-Aventis Germany. David Owens has received honoraria from Boehringer Ingelheim, Eli Lilly, Sanofi and Takeda for lectures and/or advisory boards. Acknowledgements: The contents of the paper and the opinions expressed within it are those of the authors, and it was the decision of the authors to submit the manuscript for publication. The authors take responsibility for the writing of this manuscript, including critical review and editing of each draft, and approval of the submitted version. The authors received writing/editorial support in the preparation of this manuscript provided by Catherine Amey from Touch Medical Media, this was funded by Sanofi. Compliance with Ethics: This article involves a review of the literature and did not involve any studies with human or animal subjects performed by any of the authors. Authorship: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: 11 August 2016 Accepted: 13 February 2017 Citation: European Endocrinology, 2017;13(1):21–5 Corresponding Author: David R Owens, Diabetes Research Group, College of Medicine, University of Swansea, Wales, UK. E: OwensDR@cardiff.ac.uk Support: The publication of this article was supported by Sanofi. The International Diabetes Federation (IDF) estimated that the total number of adults (20–79 years) living with diabetes in 2015 was 415 million and that by 2040, the number is predicted to rise to 642 million (see Figure 1). 1 In countries with a low healthcare budget, biosynthetic human insulin is the mainstay of effective therapy, and is now available from an increasing number of suppliers, at an affordable price locally. However, the overall cost of diabetes care has been increasing due to the dramatic and relentless increase in prevalence globally. A significant part is related to cost of insulin in the form of human insulin, and the much more expensive option of analogue insulins. Insulin therapy is indispensable in type 1 diabetes (T1DM) and is essential for type 2 diabetes (T2DM), first presenting at an advanced stage or when orally active antidiabetic drugs (OAD) fail to maintain adequate glycaemic control with the many newer therapeutic options increasingly costly. The American Diabetes Association (ADA) estimates that the total cost of known diabetes in the US rose by about 40% over a five-year period from US$174 billion in 2007 to US$245 billion in 2012. 2 representing 20% of all healthcare dollars in the US. A significant part of this increase was attributed to the cost of new analogue insulins and new OAD drugs. In contrast, worldwide, the cost of recombinant human insulin has been decreasing, due to large-scale production, competition between insulin manufacturers in different geographic areas (for example, India and Asian countries). In the US, human insulin formulations are now often available from drugstore pharmacies without a prescription. This includes the classically low-priced category of insulin vials and syringes, and also some insulin pen devices. Interestingly, in the US recently a price differential has developed between regular human insulin and intermediate-acting human neutral protamine hagedorn (NPH) insulin. The situation is very different in low-income countries, where access to recombinant human insulin formulations at affordable price levels remains to be established and/or maintained. This is very obviously a question to be addressed by national and regional healthcare systems. TOU CH MED ICA L MEDIA 21