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. 2014 Jan;8(1):6-13.
doi: 10.1177/1932296813516958. Epub 2014 Jan 1.

Biosimilar Insulins: Basic Considerations

Lutz Heinemann  1 , Marcus Hompesch  2
Affiliations

Biosimilar Insulins: Basic Considerations

Lutz Heinemann et al. J Diabetes Sci Technol. 2014 Jan.

Abstract

Until now most of the insulin used in developed countries has been manufactured and distributed by a small number of multinational companies. Beyond the established insulin manufacturers, a number of new players have developed insulin manufacturing capacities based on modern biotechnological methods. Because the patents for many of the approved insulin formulations have expired or are going to expire soon, these not yet established companies are increasingly interested in seeking market approval for their insulin products as biosimilar insulins (BI) in highly regulated markets like the EU and the United States. Differences in the manufacturing process (none of the insulin manufacturing procedures are 100% identical) can lead to insulins that to some extent may differ from the originator insulin. The key questions are if subtle differences in the structure of the insulins, purity, and so on are clinically relevant and may result in different biological effects. The aim of this article is to introduce and discuss basic aspects that may be of relevance with regard to BI.

Keywords: biosimilar insulin; insulin analogs; insulin antibodies; insulin formulations; insulin glargine; insulin therapy.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LH is shareholder of the Profil Institut für Stoffwechselforschung, Neuss, Germany and Profil Institute for Clinical Research, San Diego, USA. LH is a consultant for a number of companies that are developing novel diagnostic and therapeutic options for diabetes therapy. MH is the CEO and a shareholder of the Profil Institute for Clinical Research, San Diego, USA. This institute performs clinical trials with a number of companies that are developing novel diagnostic and therapeutic options for diabetes therapy.

Figures

Figure 1.
Figure 1.
Glucose infusion rates of Solumarv (soluble insulin), Isomarv (NPH insulin), Combimarv (combination of 30% Solumarv and 70% of Isomarv). These are original figures from the EMA Withdrawal Assessment Report (Solumarv: http://www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2013/02/WC500138886.pdf, Isomarv: http://www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2013/02/WC500138885.pdf, Combimarv: http://www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2013/02/WC500138884.pdf).
See this image and copyright information in PMC

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