title: Biosimilar medicines - Review.
abstract: BACKGROUND
  By definition, biosimilars are similar to a biological reference that has already received marketing authorization for biologic drugs.The purpose of biosimilars is reducing costs, thus increasing access to this treatment, however, the concerns of health professionals and users refer to the fact that to reduce costs will not neglecting the quality, effectiveness and especially security.
  
  
  OBJECTIVE
  The aim of this study is then to assess the degree of similarity between the biosimilar and its reference biopharmaceuticals, trying to understand the production process, requirements necessary for approval, and its impact on the quality, safety, efficacy and costs.
  
  
  METHODS
  For the systematic review without meta-analysis, we researched articles to the b-on, Pubmed and Medscape to 2005-2014, and selected 23 articles that contributed to the verification of the objectives of this study.
  
  
  RESULTS
  Several studies indicate that overall the biosimilar and biological reference showed no significant differences except those inherent to the production process, being the first susceptible to comparability tests demonstrating the similarity in terms of clinical efficacy and safety.
  
  
  CONCLUSIONS
  Biosimilars will be increasingly present in the future as promising therapeutic arsenal and targeted therapy, however, issues related to immunogenicity, interchangeability, automatic substitution and extrapolation of indications should continue to be studied and debated.
authors.affiliation: Polytechnic Institute of Coimbra, ESTESC-Coimbra Health School, Department of Pharmacy, Coimbra, Portugal.
authors.forename: Camila
authors.initials: C
authors.lastname: Dos Reis
authors.affiliation: Biophysics Unit-IBILI, Faculty of Medicine of University of Coimbra, Portugal.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Teixo
authors.affiliation: Biophysics Unit-IBILI, Faculty of Medicine of University of Coimbra, Portugal.|Polytechnic Institute of Coimbra, ESTESC-Coimbra Health School, Department of Biomedical Laboratory Sciences, Coimbra, Portugal.|Center of Investigation in Environment, Genetics and Oncobiology (CIMAGO), Faculty of Medicine of University of Coimbra, Portugal.
authors.forename: Fernando
authors.initials: F
authors.lastname: Mendes
authors.affiliation: Polytechnic Institute of Coimbra, ESTESC-Coimbra Health School, Department of Pharmacy, Coimbra, Portugal.
authors.forename: Rui Santos
authors.initials: RS
authors.lastname: Cruz
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000494:pharmacology* / Q000592:standards*; D057915:Drug Substitution / Q000009:adverse effects / Q000592:standards*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D006801:Humans
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: Biosimilars; biologics; efficacy; extrapolation; immunogenicity; interchangeability; safety