TY  - JOUR
A1  - Mbanya, Jean Claude
A1  - Sandow, Jürgen
A1  - Landgraf, Wolfgang
A1  - Owens, David R.
T1  - Recombinant human insulin in global diabetes management – focus on clinical efficacy
T2  - European endocrinology
N2  - Biosynthetic 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.
KW  - Diabetes mellitus
KW  - biosynthetic human insulin
KW  - biosimilar and analogue insulins
KW  - regulatory requirements
KW  - cost
KW  - global access
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/46291
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-462916
SN  - 1758-3772
SN  - 1758-3780
N1  - 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.
VL  - 13
IS  - 1
SP  - 21
EP  - 25
PB  - touchENDOCRINOLOGY
CY  - Goring-on-Thames
ER  -