title: [Regulatory aspects of biosimilars. Myths and facts].
abstract: BACKGROUND
  Biosimilars are currently a hot topic and there are many unsolved questions, misunderstandings and sometimes considerable uncertainty, especially among clinicians and patients. Regulatory agencies, such as the European Medicines Agency (EMA) issue guidelines for the development and approval of biosimilars, which are based on scientific principles.
  
  
  OBJECTIVE
  This article addresses some of the frequently noted misunderstandings and misperceptions. For example, why biosimilars are (or can only be) "similar" but not "identical" compared to the original pharmaceutical product, and aspects, such as the pharmaceutical quality of biosimilars, immunogenicity and the approval process for biosimilars are highlighted.
authors.affiliation: Abteilung Arzneimittelzulassung und -Zugänglichkeit, Danish Health and Medicines Authority, Axel Heides Gade 1, 2300, Kopenhagen, Dänemark. ckschneider@gmx.de.|Biosimilar Medicinal Products Working Party (BMWP), Europäische Arzneimittelagentur, London, UK. ckschneider@gmx.de.|TwincoreZentrum für Experimentelle und Klinische Infektionsforschung, Hannover, Deutschland. ckschneider@gmx.de.
authors.forename: C K
authors.initials: CK
authors.lastname: Schneider
authors.affiliation: Biosimilar Medicinal Products Working Party (BMWP), Europäische Arzneimittelagentur, London, UK.|Fachgebiets Diabetes mellitus/Kardiovaskuläres System, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Deutschland.
authors.forename: M
authors.initials: M
authors.lastname: Weise
mesh_terms: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000331:legislation & jurisprudence*; D004353:Drug Evaluation, Preclinical / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D057915:Drug Substitution / Q000592:standards; D005062:European Union; D033161:Government Regulation
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals
keywords: Approval; European Medicines Agency; Guidelines; Original formulation; Regulatory agencies