title: Biosimilar safety factors in clinical practice.
abstract: OBJECTIVE
  This article provides insight into the guidelines issued by the European Medicines Agency (EMA) and the draft guidances issued by the US Food and Drug Administration (FDA) regarding potential safety considerations associated with the development and use of biosimilars.
  
  
  METHODS
  EMA and FDA guidelines and the literature were reviewed to identify recommendations and experience of manufacturers regarding the safety of biosimilars.
  
  
  RESULTS
  Recent results of phase 3 comparability clinical trials comparing biosimilars with their reference products, and the approval of a biosimilar infliximab by several regulatory agencies, demonstrate the growing importance of biosimilars in inflammatory diseases. The safety profiles of biosimilars developed according to regulatory guidelines appear to be highly similar to the reference product, and postmarketing pharmacovigilance programs are in place. Additional topics related to biosimilars, such as interchangeability, automatic substitution, and nomenclature, are discussed.
  
  
  CONCLUSIONS
  Safety considerations in the development of biosimilars are an important focus of regulatory guidelines, although topics such as interchangeability, automatic substitution, and nomenclature are still being debated.
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University Vienna, Wien, Austria. Electronic address: reinisw@mcmaster.ca.
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.affiliation: Department of Rheumatology and Department of Medicine 3, Vienna General Hospital, Medical University Vienna, Vienna, Austria; 2nd Department of Medicine, Center for Rheumatic Diseases, Hietzing Hospital, Vienna, Austria.
authors.forename: Josef
authors.initials: J
authors.lastname: Smolen
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000592:standards* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000458:organization & administration; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D005060:Europe; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D005791:Patient Care; D061214:Patient Safety; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D059451:Biosimilar Pharmaceuticals