Biosimilar insulins: a European perspective.
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.
Endocrinology, Academic Medical Centre, Amsterdam, The Netherlands.
J H
JH
DeVries
S C L
SC
Gough
J
J
Kiljanski
L
L
Heinemann
D059451:Biosimilar Pharmaceuticals / Q000592:standards* / Q000627:therapeutic use; D016568:Drugs, Generic / Q000592:standards; D005060:Europe; D006801:Humans; D061385:Insulins / Q000592:standards* / Q000627:therapeutic use; D007880:Legislation, Drug
D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic; D061385:Insulins
biosimilars; diabetes; insulin; regulatory requirements