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Review
. 2020 Nov 17;13(11):400.
doi: 10.3390/ph13110400.

Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review

Arnold G Vulto  1   2 , Jackie Vanderpuye-Orgle  3 , Martin van der Graaff  4 , Steven R A Simoens  2 , Lorenzo Dagna  5 , Richard Macaulay  6 , Beenish Majeed  6 , Jeffrey Lemay  7 , Jane Hippenmeyer  8 , Sebastian Gonzalez-McQuire  8
Affiliations
Review

Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review

Arnold G Vulto et al. Pharmaceuticals (Basel). .

Abstract

Introduction: Biosimilars have the potential to enhance the sustainability of evolving health care systems. A sustainable biosimilars market requires all stakeholders to balance competition and supply chain security. However, there is significant variation in the policies for pricing, procurement, and use of biosimilars in the European Union. A modified Delphi process was conducted to achieve expert consensus on biosimilar market sustainability in Europe.

Methods: The priorities of 11 stakeholders were explored in three stages: a brainstorming stage supported by a systematic literature review (SLR) and key materials identified by the participants; development and review of statements derived during brainstorming; and a facilitated roundtable discussion.

Results: Participants argued that a sustainable biosimilar market must deliver tangible and transparent benefits to the health care system, while meeting the needs of all stakeholders. Key drivers of biosimilar market sustainability included: (i) competition is more effective than regulation; (ii) there should be incentives to ensure industry investment in biosimilar development and innovation; (iii) procurement processes must avoid monopolies and minimize market disruption; and (iv) principles for procurement should be defined by all stakeholders. However, findings from the SLR were limited, with significant gaps on the impact of different tender models on supply risks, savings, and sustainability.

Conclusions: A sustainable biosimilar market means that all stakeholders benefit from appropriate and reliable access to biological therapies. Failure to care for biosimilar market sustainability may impoverish biosimilar development and offerings, eventually leading to increased cost for health care systems and patients, with fewer resources for innovation.

Keywords: Delphi technique; biosimilar market; biosimilar sustainability; biosimilar/supply and distribution.

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Conflict of interest statement

A.G.V. reports personal fees from AbbVie, Accord-Healthcare, Amgen, Biogen Idec, Febelgen, Fresenius-Kabi, Hexal, Medicines for Europe, Mundipharma, Novartis, Pfizer, Samsung, and Sandoz; J.V.-O., R.M., and B.M. are employees of Parexel who were contracted by Amgen; M.v.d.G. reports personal fees from Amgen and BioMarin; L.D. reports personal fees from Abbvie, Amgen, Biogen, BMS, Celltrion, Novartis, Pfizer, Roche, Sanofi-Genzyme, and SOBI; J.L. and J.H. are employees of Amgen; S.G.M. is an Amgen employee and stockholder; S.S. is one of the founders of the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL). He was involved in a European stakeholder roundtable on biologics and biosimilars sponsored by Amgen, Merck Sharp and Dohme, and Pfizer; he has participated in advisory board meetings for Amgen and Pfizer; and he has contributed to studies on biologics and biosimilars for Celltrion, Hospira, Mundipharma, and Pfizer. S.S. is also member of the leadership team of the International Society for Pharmacoeconomics and Outcomes Research Special Interest Group on Biosimilars.

Figures

Figure A1
Figure A1
PRISMA Flow Diagram. RCT, randomized controlled trial. SLR, systematic literature review.
Figure 1
Figure 1
Modified Delphi process.
See this image and copyright information in PMC

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