Policies for biosimilar uptake in Europe: An overview

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 TrifiròPatricia 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

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

145 Citations (Scopus)


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.

Original languageEnglish
Article numbere0190147
JournalPLoS ONE
Issue number12
Publication statusPublished - Dec 2017
Externally publishedYes


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