title: Barriers to the uptake of biosimilars and possible solutions: a Belgian case study.
abstract: BACKGROUND
  Biosimilars are medicinal products that are similar to a biopharmaceutical that has already been authorised. As biopharmaceuticals are expected to dominate the best-selling pharmaceuticals worldwide by 2016, the emergence of biosimilars imposes an important challenge for governments. At this moment, the uptake of biosimilars in Belgium is limited, with market shares close to 0%.
  
  
  OBJECTIVE
  This study aimed to identify the barriers that impede the uptake of biosimilars in Belgium.
  
  
  METHODS
  Semi-structured interviews were conducted to investigate in depth the barriers to the uptake of biosimilars in Belgium. Respondents were selected through selective sampling so that all different stakeholders were represented (authorities, physicians, pharmacists, patients, academics and industry). Respondents were contacted by e-mail and letter with a request for participation. A thematic framework was used to analyze the data.
  
  
  RESULTS
  Three main barriers to the uptake of biosimilars in the Belgian market were identified: a lack of confidence towards biosimilars by some stakeholders; uncertainty about the interchangeability and substitution of biosimilars; and a hospital financing system that discourages the use of them. Providing all stakeholders with objective information on the concept of biosimilars, reforming the financing of hospitals, developing and implementing prescription quota in hospitals, setting up patient registries for biosimilars and speeding up the pricing and reimbursement process of biosimilars are suggested solutions to increase the uptake of biosimilars in Belgium.
  
  
  CONCLUSIONS
  To fully capture the potential savings of biosimilars, governments should take measures to increase their uptake. The Belgian government, and also the manufacturers of biosimilars, should take measures to reduce the uncertainties related to biosimilars and raise confidence among prescribers. In addition, the financing of hospitals should be reformed and incentives should be developed to stimulate physicians to prescribe biosimilars.
authors.affiliation: KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, O&N 2, P.O. Box 521, 3000, Leuven, Belgium, pieter.dylst@pharm.kuleuven.be.
authors.forename: Pieter
authors.initials: P
authors.lastname: Dylst
authors.forename: Arnold
authors.initials: A
authors.lastname: Vulto
authors.forename: Steven
authors.initials: S
authors.lastname: Simoens
mesh_terms: D001530:Belgium; D001702:Biopharmaceutics / Q000191:economics* / Q000639:trends; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000191:economics*; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D017723:Drug Utilization Review; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011795:Surveys and Questionnaires
chemical_list: D059451:Biosimilar Pharmaceuticals