Article Text

PDF
Original article
How to select a biosimilar
  1. Niels Boone1,
  2. Hugo van der Kuy1,
  3. Mike Scott2,
  4. Jill Mairs2,
  5. Irene Krämer3,
  6. Arnold Vulto4,
  7. Rob Janknegt1
  1. 1Department of Clinical Pharmacy and Toxicology, Orbis Medical Center, Sittard-Geleen, The Netherlands
  2. 2Department of Clinical Pharmacy, Antrim Area Hospital, Antrim, UK
  3. 3University Medical Center, Johannes Gutenberg University, Mainz, Germany
  4. 4Department of Clinical Pharmacy and Toxicology, Erasmus Medical Center, Rotterdam, The Netherlands
  1. Correspondence to Niels Boone, Orbis Medical Center, Department of Clinical Pharmacy and Toxicology, PO Box 5500, Sittard-Geleen NL 6130 MB, The Netherlands; nwboone{at}gmail.com

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.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.