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Düsseldorf, Germany

Heinemann L.,Science and Co.
Expert Opinion on Biological Therapy | Year: 2012

Until now most insulin used in developed countries is manufactured and distributed by a small number of multinational companies. Other pharmaceutical companies many of these are located in countries such as India or China are also able to manufacture insulin with modern biotechnological methods. Additionally, the patents for many insulin formulations have expired or are going to expire soon. This enables such companies to produce insulins and to apply for market approval of these as biosimilar insulins (BIs) in highly regulated markets such as the EU or the US. To understand the complexity of BIs' approval and usage, scientific and regulatory aspects have to be discussed. Differences in the manufacturing process (none of the insulin-manufacturing procedures are identical) result in the fact that all insulin that might become BIs differ from the originator insulin to some extent. The question is, have such differences in the structure of the insulin molecule and or the purity and so on clinically relevant consequences for the biological effects induced or not. The guidelines already in place in the EU for market approval require that the manufacturer demonstrates that his insulin has a safety and efficacy profile that is similar to that of the 'original' insulin formulation. Recently guidelines for biosimilars were issued in the US; however, these do not cover insulin. Although a challenging approval process for insulins to become BI might be regarded as a hurdle to keep companies out of certain markets, it is fair to say that the potential safety and efficacy issues surrounding BI are substantial and relevant, and do warrant a careful and evidence-driven approval process. Nevertheless, it is very likely that in the next years, BIs will come to the market also in highly regulated markets. © 2012 Informa UK, Ltd. Source

Heinemann L.,Science and Co.
Diabetes Technology and Therapeutics | Year: 2016

An insulin infusion set (IIS) is a key component of insulin pumps. In daily practice issues with the IIS appear to be as relevant for a successful insulin therapy as the pumps themselves. The insulin is applied to the subcutaneous tissue via a Teflon® (Dupont, Wilmington, DE) or steel cannula. There are intensive discussions about the impact the choice of material for insulin application has on insulin pharmacokinetics. In this review, this factor and others that are known to have an impact on the successful usage of IIS are discussed. © Mary Ann Liebert, Inc. 2016. Source

Heinemann L.,Science and Co. | Muchmore D.B.,Halozyme Therapeutics
Journal of Diabetes Science and Technology | Year: 2012

Optimal coverage of prandial insulin requirements remains an elusive goal. The invention of rapid-acting insulin analogs (RAIAs) was a big step forward in reducing postprandial glycemic excursions in patients with diabetes in comparison with using regular human insulin; however, even with these, the physiological situation cannot be adequately mimicked. Developing ultrafast-acting insulins (UFIs) - showing an even more rapid onset of action and a shorter duration of action after subcutaneous (SC) administration - is another step forward in achieving this goal. The need for UFIs has been gradually recognized over the years, and subsequently, a number of different approaches to cover this need are in clinical development. A rapid increase in circulating insulin levels can be achieved by different measures: modification of the primary structure of insulin molecule (as we know from RAIAs), addition of excipients that enhance the appearance in the monomeric state post-injection, or addition of enzymes that enable more free spreading of the insulin molecules in the SC tissue. Other measures to increase the insulin absorption rate increase the local blood flow nearby the insulin depot in the SC tissue, injecting the insulin intradermally or applying via another route, e.g., the lung. The development of these approaches is in different stages, from quite early stages to nearing market authorization. In time, daily practice will show if the introduction of UFIs will fulfill their clinical promise. In this review, the basic idea for UFIs will be presented and the different approaches will be briefly characterized. © Diabetes Technology Society. Source

Heinemann L.,Science and Co. | Krinelke L.,Roche Holding AG
Journal of Diabetes Science and Technology | Year: 2012

Continuous subcutaneous insulin infusion from an insulin pump depends on reliable transfer of the pumped insulin to the subcutaneous insulin depot by means of an insulin infusion set (IIS). Despite their widespread use, the published knowledge about IISs and related issues regarding the impact of placement and wear time on insulin absorption/insulin action is relatively small. We also have to acknowledge that our knowledge is limited with regard to how often patients encounter issues with IISs. Reading pump wearer blogs, for instance, suggests that these are a frequent source of trouble. There are no prospective clinical studies available on current IIS and insulin formulations that provide representative data on the type and frequency of issues with infusion sets. The introduction of new IISs and patch pumps may foster a reassessment of available products and of patient problems related to their use. The aim of this review is to summarize the current knowledge and recommendations about IISs and to highlight potential directions of IIS development in order to make insulin absorption safer and more efficient. © Diabetes Technology Society. Source

Heinemann L.,Science and Co. | DeVries J.H.,University of Amsterdam
Diabetes Technology and Therapeutics | Year: 2016

Continuous glucose monitoring (CGM) systems have been available for more than 15 years by now. However, market uptake is relatively low in most countries; in other words, relatively few patients with diabetes use CGM systems regularly. One major reason for the reluctance of patients to use CGM systems is the costs associated (i.e., in most countries no reimbursement is provided by the health insurance companies). In case reimbursement is in place, like in the United States, only certain patient groups get reimbursement that fulfills strict indications. This situation is somewhat surprising in view of the mounting evidence for benefits of CGM usage from clinical trials: most meta-analyses of these trials consistently show a clinically relevant improvement of glucose control associated with a reduction in hypoglycemic events. More recent trials with CGM systems with an improved CGM technology showed even more impressive benefits, especially if CGM systems are used in different combinations with an insulin pump (e.g., with automated bolus calculators and low glucose suspend features). Nevertheless, sufficient evidence is not available for all patient groups, and more data on cost-efficacy are needed. In addition, good data from real-world studies/registers documenting the benefits of CGM usage under daily life conditions would be of help to convince healthcare systems to cover the costs of CGM systems. In view of the ongoing improvements in established needle-type CGM systems, the fact that new CGM technology will come to the market soon (e.g., implantable sensors), that CGM-like systems are quite successfully at least in certain markets (like the flash glucose monitoring systems), and that the first artificial pancreas systems will come to the market in the next few years, there is a need to make sure that this major improvement in diabetes therapy becomes more widely available for patients with diabetes, for which better reimbursement is essential. © Copyright 2016, Mary Ann Liebert, Inc. 2016. Source

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