How to select a biosimilar

N Boone, H van der Kuy, M Scott, J Mairs, I Kramer, Arnold Vulto, R Janknegt

Research output: Contribution to journalArticleAcademic

17 Citations (Scopus)

Abstract

In the past few years biosimilars have penetrated the market following the expiry of patents of originator variants. This offers the opportunity to apply high-tech protein products at a lower cost. In contrast to small-molecule generics, clinicians and pharmacists have found it difficult to judge the efficacy and safety profiles of complex protein products. In recent years, the European Medicines Agency (EMA) has gained knowledge on assessing comparability between biosimilars and originator products in scientific and legal areas. This article provides an overview of an extensive set of 31 previously drawn biosimilar selection criteria and describes how several of these criteria are covered by EMA regulations and guidelines. A panel of experts (authors) reviewed the criteria and produced a shortlist of 10 criteria relevant for clinicians and pharmacists.
Original languageUndefined/Unknown
Pages (from-to)275-286
Number of pages12
JournalEuropean Journal Of Hospital Pharmacy-Sciene And Practice
Volume20
Issue number5
DOIs
Publication statusPublished - 2013

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