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Biosimilar insulins: opportunities and challenges

commercial production of animal insulins, a number of key developments have taken place over the last 90 years, including the publication of the amino acid sequence of insulin in 1951 by Frederick Sanger and the subsequent publication of its three-dimensional structure in 1969 by Dorothy Hodgkin. These undoubtedly paved the way for the development and application of recombinant DNA technology for the production of human and then analogue insulins, such that we now have a range of short-acting, long-acting and mixture insulins for our patients with diabetes. During this time, the scientific progress of researchers in developing ever more effective and convenient insulins has been adequately matched by the implementation of high standards of quality control and a rigorous process of regulatory review. In the same way that technological advances in insulin production will allow the production of biosimilar insulins, it is crucial that these medicines are subject to the same standards of approval, to ensure that they exhibit similar efficacy and safety profiles to those of the original insulin product. As the expiry date for the patent of a number of insulins rapidly approaches – including, for example, insulin glargine (November 2014 in Europe and February 2015 in the USA) – much interest is emerging around the development of second generation copies of the original therapeutic.1 The expectation, by many, is that an opportunity exists to produce a similar product at a lower price which will introduce greater competition in the market place, and which ultimately will be of benefit to health care providers, the payers and of course our patients. While to some extent this may be the case, it is important to consider not only the opportunities but also the challenges and dangers that we may face, when companies attempt to produce and market a ‘copy-cat’ biological product, or biosimilar insulin.