![]() The EU regulatory designation of biosimilarity is without prejudice to prescribing and reimbursement decisions, which remain the jurisdiction of individual EU Member States. īecause confusion about the distinct notions of switching, interchangeability and substitutability have tended to confound the discussion, a recent European Commission sponsored consensus document provides the definitions of these terms, as shown in Table 1. Key to the commercial success of biosimilars is the way they are accepted for use in clinical practice and if and when patients can be switched to and from innovator products and biosimilars. The price reductions for currently authorized biosimilars have been modest (20–30%), it is expected that the price reductions for biosimilar monoclonal antibodies will be larger (up to 50%). The promise of cost savings is the main potential of biosimilars. ![]() Biotechnology product sales have grown from US$36 billion in 2002 to US$163 billion in 2012 and there will be increasing pressure on healthcare systems to reduce drug expenditures. The availability of lower-priced, therapeutically equivalent alternatives will make prescribing driven more by market forces, especially in those countries where patients pay out-of-pocket, but also for evermore constraint healthcare systems. In September 2013, the first biosimilar version of a monoclonal antibody (mAb) was authorized in the European Union (EU). Submitted: 24 February 2014 Revised: 31 March 2014 Accepted: 3 April 2014 Published online first: 16 April 2014 Introduction We conclude that it will be highly challenging to establish interchangeability of biosimilars, and it should be questioned whether the ‘higher’ standard required for designation of interchangeability adds to the benefit for patients. Our discussion will be mainly focused on monoclonal antibodies. Here we will discuss challenges to the regulatory approach for establishing interchangeability, in the sense of considering biosimilar versions as therapeutic equivalents that could – depending on National or Federal Law – be substituted at the pharmacy level, and compare these to the weight of real-world evidence of the risks of potential differences that could modify longer-term clinical benefit-to-risk. A particular concern is related to the question of whether a biosimilar can be safely interchanged with the originator product or other biosimilars. Continued abuse of our services will cause your IP address to be blocked indefinitely.The arrival of biosimilars has led to considerable debate on how they can be used in clinical practice. Please fill out the CAPTCHA below and then click the button to indicate that you agree to these terms. If you wish to be unblocked, you must agree that you will take immediate steps to rectify this issue. If you do not understand what is causing this behavior, please contact us here. If you promise to stop (by clicking the Agree button below), we'll unblock your connection for now, but we will immediately re-block it if we detect additional bad behavior.
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