title: Demonstrating Value for Biosimilars: A Conceptual Framework.
abstract: BACKGROUND
  The value proposition for biosimilars can be characterized as a concept that moves beyond the argument of cost reduction relative to the innovator biologic drug and into a framework that incorporates the diverse needs of key healthcare stakeholders during the transition from clinical development to commercialization in the marketplace.
  
  
  OBJECTIVE
  To identify factors that facilitate and inhibit the development, commercialization, and adoption of biosimilars, and to recommend modifications in program design that are likely to support the demonstration of the value of biosimilars for payers, providers, and patients.
  
  
  METHODS
  The primary data sources for this article include surveys conducted by Boston Healthcare Associates with payers and clinicians in the United States and the European Union 5 markets and blinded international protocol feasibility assessments completed by Worldwide Clinical Trials. Survey methodology used either convenience or purposeful sampling as appropriate, with participants extracted from diverse audiences, representative of those who generate or evaluate clinical data shaping the economic exchange and preferential status influencing physician adoption and patient access to biosimilars. Patient characteristics and psychosocial issues influencing patients' perception of small-molecule generics were extracted from the available literature to inform exploratory hypotheses, given the relative absence of such information for biosimilars.
  
  
  CONCLUSIONS
  This article reviews the current evidence and summarizes results of surveys conducted with payers, providers, and drug investigation sites in the United States. Based on a review of published literature, as well as these survey results, conflicting and convergent demands exist for gathering data related to biosimilars. The motivations and data needs for these new agents are diverse, requiring adjudication of regulatory, economic, and clinical incentives beginning at program inception and extending through commercialization of the final biosimilar agent.
  
  
  CONCLUSIONS
  The development and commercialization of biosimilars represent an international activity that can encounter unanticipated challenges, as well as opportunities to achieve clinical and commercial success. Evolving regulatory guidance mapped in relation to payer, physician, and patient sentiments may inform the biosimilar development program designs, implementation, and positioning of the new drug.
authors.affiliation: Director, Boston Healthcare Associates, MA.
authors.forename: Sotiris
authors.initials: S
authors.lastname: Rompas
authors.affiliation: Senior Vice President, Boston Healthcare Associates, MA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Goss
authors.affiliation: Senior Vice President, Clinical Study Start-Up and Regulatory Affairs, Worldwide Clinical Trials, King of Prussia, PA.
authors.forename: Sally
authors.initials: S
authors.lastname: Amanuel
authors.affiliation: Director, Global Regulatory Affairs, Worldwide Clinical Trials, King of Prussia, PA.
authors.forename: Victoria
authors.initials: V
authors.lastname: Coutinho
authors.affiliation: Director, Scientific Affairs, Worldwide Clinical Trials, King of Prussia, PA.
authors.forename: Zhihong
authors.initials: Z
authors.lastname: Lai
authors.affiliation: Senior Vice President, Scientific Affairs, Worldwide Clinical Trials, King of Prussia, PA.
authors.forename: Paola
authors.initials: P
authors.lastname: Antonini
authors.affiliation: Chief Medical and Scientific Officer, Worldwide Clinical Trials, King of Prussia, PA.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Murphy
keywords: biologics; biosimilar adoption; biosimilars; commercialization; drug development; generic drugs; patients; payers; providers; reference drug; regulatory guidance; value proposition