Biosimilar insulins: a European perspective

Diabetes Obes Metab. 2015 May;17(5):445-51. doi: 10.1111/dom.12410. Epub 2014 Nov 27.


Biosimilar insulins are likely to enter clinical practice in Europe in the near future. It is important that clinicians are familiar with and understand the concept of biosimilarity and how a biosimilar drug may differ from its reference product. The present article provides an overview of biosimilars, the European regulatory requirements for biosimilars and safety issues. It also summarizes the current biosimilars approved in Europe and the key clinical issues associated with the use of biosimilar insulins.

Keywords: biosimilars; diabetes; insulin; regulatory requirements.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Biosimilar Pharmaceuticals / standards*
  • Biosimilar Pharmaceuticals / therapeutic use
  • Drugs, Generic / standards
  • Europe
  • Humans
  • Insulins / standards*
  • Insulins / therapeutic use
  • Legislation, Drug


  • Biosimilar Pharmaceuticals
  • Drugs, Generic
  • Insulins