title: Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices.
abstract: The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy on the scientific basis for extrapolation of indications for biosimilars, which has been strengthened by diverging global regulatory decision making. Closely related to the question of extrapolation is the question of how to communicate the evidence base for authorizing biosimilars to healthcare professionals. In this paper we will consider some of the discussions around extrapolation of indications and the implications of decisions of various regulatory agencies in the world regarding the authorization and labeling of biosimilars.
authors.affiliation: Department of Pharmaceutical Sciences, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. h.ebbers@uu.nl.|Utrecht Centre of Excellence for Affordable Biotherapeutics for Public Health, Utrecht, The Netherlands. h.ebbers@uu.nl.
authors.forename: Hans C
authors.initials: HC
authors.lastname: Ebbers
authors.affiliation: NDA Advisory Services Ltd, Prime House, Challenge Court, Barnett Wood Lane, Leatherhead, Surrey, KT22 7DE, UK. paul.chamberlain@ndareg.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Chamberlain
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000592:standards*; D003657:Decision Making; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000592:standards*; D004335:Drug and Narcotic Control; D006801:Humans; D038622:Internationality
chemical_list: D059451:Biosimilar Pharmaceuticals