Biosimilar insulins

Expert Opinion on Biological Therapy
Lutz Heinemann

Abstract

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 sim...Continue Reading

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Citations

Oct 30, 2012·Diabetes Technology & Therapeutics·Lutz Heinemann
Mar 6, 2013·Diabetes Technology & Therapeutics·Thomas Danne, Jan Bolinder
Jun 25, 2014·The American Journal of Gastroenterology·Michael S EpsteinUNKNOWN FDA-Related Matters Committee of the American College of Gastroenterology
Sep 5, 2015·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Anne L PetersSteven V Edelman
Oct 11, 2015·The Lancet. Diabetes & Endocrinology·Jing Luo, Aaron S Kesselheim
Nov 8, 2014·Diabetes, Obesity & Metabolism·J H DeVriesL Heinemann
Nov 22, 2014·Postgraduate Medicine·Fernando J Lavalle-González, Hootan Khatami
Mar 20, 2015·Diabetes Technology & Therapeutics·Lutz HeinemannPhilip Home
Mar 27, 2018·Journal of Diabetes Investigation·Linsey GaniUNKNOWN JADE Collaborative Study Group
Mar 7, 2018·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Bahendeka SilverAnthony Makhoba
Aug 6, 2013·Journal of Diabetes Science and Technology·Lutz Heinemann, David Owens

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