Biosimilar insulins: a E uropean perspective
J. Hans DeVries, Stephen C. L. Gough, Jacek I. Kiljanski, Lutz Heinemann
Abstract
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J. Hans DeVries, Stephen C. L. Gough, Jacek I. Kiljanski, Lutz Heinemann
Abstract
Open-access reader
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.
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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.
Key concepts: Biosimilar, Medicine, Drug approval, Perspective (graphical), Clinical Practice, Risk analysis (engineering), Pharmacology, Business