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Policies for biosimilar uptake in Europe: An overview

Author

Listed:
  • Evelien Moorkens
  • Arnold G Vulto
  • Isabelle Huys
  • Pieter Dylst
  • Brian Godman
  • Simon Keuerleber
  • Barbara Claus
  • Maria Dimitrova
  • Guenka Petrova
  • Ljiljana Sović-Brkičić
  • Juraj Slabý
  • Robin Šebesta
  • Ott Laius
  • Allan Karr
  • Morgane Beck
  • Jaana E Martikainen
  • Gisbert W Selke
  • Susan Spillane
  • Laura McCullagh
  • Gianluca Trifirò
  • Patricia Vella Bonanno
  • Asbjørn Mack
  • Antra Fogele
  • Anita Viksna
  • Magdalena Władysiuk
  • Helder Mota-Filipe
  • Dmitry Meshkov
  • Marija Kalaba
  • Simona Mencej Bedrač
  • Jurij Fürst
  • Corrine Zara
  • Peter Skiöld
  • Einar Magnússon
  • Steven Simoens

Abstract

Background: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. Objectives: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. Methods: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. Results: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. Conclusions: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Suggested Citation

  • Evelien Moorkens & Arnold G Vulto & Isabelle Huys & Pieter Dylst & Brian Godman & Simon Keuerleber & Barbara Claus & Maria Dimitrova & Guenka Petrova & Ljiljana Sović-Brkičić & Juraj Slabý & Robin Šeb, 2017. "Policies for biosimilar uptake in Europe: An overview," PLOS ONE, Public Library of Science, vol. 12(12), pages 1-17, December.
  • Handle: RePEc:plo:pone00:0190147
    DOI: 10.1371/journal.pone.0190147
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    References listed on IDEAS

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    1. Björn Wettermark & Brian Godman & Bengt Jacobsson & Flora Haaijer-Ruskamp, 2009. "Soft regulations in pharmaceutical policy making," Applied Health Economics and Health Policy, Springer, vol. 7(3), pages 137-147, September.
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    1. Katharina E. Blankart & Friederike Arndt, 2020. "Physician-Level Cost Control Measures and Regional Variation of Biosimilar Utilization in Germany," IJERPH, MDPI, vol. 17(11), pages 1-14, June.
    2. Carolina Zampirolli Dias & Brian Godman & Ludmila Peres Gargano & Pâmela Santos Azevedo & Marina Morgado Garcia & Maurílio Souza Cazarim & Laís Lessa Neiva Pantuzza & Nelio Gomes Ribeiro-Junior & Andr, 2020. "Integrative Review of Managed Entry Agreements: Chances and Limitations," PharmacoEconomics, Springer, vol. 38(11), pages 1165-1185, November.
    3. Ghyli Kirshner & Peter Makai & Chiara Brouns & Lonneke Timmers & Ron Kemp, 2024. "The impact of an ‘evergreening’ strategy nearing patent expiration on the uptake of biosimilars and public healthcare costs: a case study on the introduction of a second administration form of trastuz," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 25(7), pages 1147-1163, September.
    4. Böhm, Anna-Katharina & Steiner, Isa Maria & Stargardt, Tom, 2023. "Market diffusion of biosimilars in off-patent biologic drug markets across Europe," Health Policy, Elsevier, vol. 132(C).

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