Biological drugs have revolutionised the treatment of rheumatic diseases, and the recent expiry of the patents for many biological agents has generated considerable interest among pharmaceutical companies and regulatory agencies, and led to the marketing of highly similar, low-cost versions known as biosimilars. The increasing trend of switching patients from effective but expensive drugs to their biosimilar counterparts will have a considerable economic impact in the coming years. However, although this will greatly extend patient access the latest treatments, clinicians, scientific societies and the patients themselves have expressed a number of concerns about their long-term efficacy and safety, as well as the consequences of potentially multiple switches being dictated by economic pressure rather than medical needs. Thee aim of this review is to evaluate the pros and cons of choosing biosimilars, and whether and when they can really be considered clinically equivalent to the original drugs.
Keywords: Biosimilars; Extrapolation; Interchangeability; Originators; Switching.
Copyright © 2019. Published by Elsevier B.V.