title: Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies.
abstract: BACKGROUND
  In 2014, six of the top ten blockbuster medicines were monoclonal antibodies. This multibillion-dollar market with expiring patents is the main driver for the development of biosimilar mAbs. With the ever-increasing cost of healthcare and the economic pressure to reduce or sustain healthcare expenses, biosimilars could be instrumental in reducing costs for medication and increasing patient access to treatment.
  
  
  OBJECTIVE
  The aim of this study is to identify and describe the barriers to market access of biosimilar mAbs in the European Union and to analyze how these barriers could be overcome.
  
  
  METHODS
  A narrative literature review was carried out using the databases PubMed, Embase, and EconLit. Studies were published in English or Dutch. Additionally, the reference list of the articles was checked for relevant studies. Articles and conference papers known to the authors were included as well. Articles were also identified by searching on the website of the Generics and Biosimilars Initiative (GaBI) journal.
  
  
  RESULTS
  Six barriers were identified based on available literature: The manufacturing process, the regulatory process, intellectual property rights, lack of incentive, the impossibility of substitution, and the innovator's reach. These six barriers are presented as a possible framework to study the market access of biosimilar mAbs. Based on the literature search, recommendations can be made to overcome these barriers: (i) invest initially in advanced production processes with the help of single-use technology, experience or outsourcing (ii) gain experience with the regulatory process and establish alignment between stakeholders (iii) limit patent litigation, eliminate evergreening benefits, build out further the unitary patent and unified patent litigation system within the EU (iv) create demand-side policies, disseminate objective information (v) change attitude toward biosimilar switching/substitution, starting with physician, and patient education (vi) differentiate the biosimilar by service offerings, use an appropriate comparator in cost-effectiveness analyses.
  
  
  CONCLUSIONS
  Barriers to the market access of biosimilar mAbs could be reduced when more transparency and communication/education is used in all steps toward market access in order to increase the trust in biosimilar mAbs by all stakeholders. Only then biosimilar mAbs will be able to fully capture their cost saving potential.
authors.affiliation: Department of Pharmaceutical and Pharmacological Sciences, University of Leuven Leuven, Belgium.
authors.forename: Evelien
authors.initials: E
authors.lastname: Moorkens
authors.affiliation: Hospital Pharmacy, The Erasmus University Medical Center Rotterdam, Netherlands.
authors.forename: Clara
authors.initials: C
authors.lastname: Jonker-Exler
authors.affiliation: Department of Pharmaceutical and Pharmacological Sciences, University of Leuven Leuven, Belgium.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Huys
authors.affiliation: Department of Pharmaceutical and Pharmacological Sciences, University of Leuven Leuven, Belgium.
authors.forename: Paul
authors.initials: P
authors.lastname: Declerck
authors.affiliation: Department of Pharmaceutical and Pharmacological Sciences, University of Leuven Leuven, Belgium.
authors.forename: Steven
authors.initials: S
authors.lastname: Simoens
authors.affiliation: Hospital Pharmacy, The Erasmus University Medical Center Rotterdam, Netherlands.
authors.forename: Arnold G
authors.initials: AG
authors.lastname: Vulto
keywords: European Union; biosimilar; literature review; market access; monoclonal antibody