title: Biosimilars: in support of extrapolation of indications.
abstract: Biosimilars have the potential to lead to enormous cost savings in healthcare without reducing the level of care for patients. In Europe, biosimilars have to demonstrate comparability in an extensive biosimilarity exercise including analytical, preclinical and comparative clinical studies. By successfully completing the biosimilarity exercise, the biosimilar shows that all aspects that are considered relevant for the clinical activity of the product fall within the same range as observed for the innovator. It should be carefully considered whether the benefit of additional information from more comparative clinical studies weighs up to the additional barriers such studies create for biosimilars to enter clinical practice.
authors.affiliation: Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Department of Pharmaceutics, Utrecht, The Netherlands; Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, The Netherlands. Electronic address: h.ebbers@uu.nl.
authors.forename: Hans C
authors.initials: HC
authors.lastname: Ebbers
mesh_terms: D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000191:economics*; D005060:Europe; D019317:Evidence-Based Medicine; D005765:Gastrointestinal Agents / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy / Q000191:economics; D000069285:Infliximab; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000191:economics
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: Authorization; Biosimilar; Extrapolation; Infliximab; Safety; Tumor necrosis factor alpha