Evidence map›Paper›PMID 33213079›Full record

ReviewPharmaceuticals (Basel, Switzerland)2020

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

Arnold G Vulto, Jackie Vanderpuye-Orgle, Martin van der Graaff, Steven R A Simoens, Lorenzo Dagna, Richard Macaulay, Beenish Majeed, Jeffrey Lemay, Jane Hippenmeyer, Sebastian Gonzalez-McQuire

Abstract readReview
In one paragraph

Review in Pharmaceuticals (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  5. Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  6. Article
  7. Can Endangered Biosimilar Markets be Rescued? The Need to Bridge Competing Interests for Long-Term Gain.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Arnold G VultoHospital Pharmacy, Erasmus University Medical Center, NL-3015 CN Rotterdam, The Netherlands.ORCID 0000-0002-8439-2800
Jackie Vanderpuye-OrgleAccess Consulting, Parexel International, Billerica, MA 01821, USA.
Martin van der GraaffEx-National Health Care Institute, Zorginstituut Nederland (ZIN), NL-1110 AH Diemen, The Netherlands.
Steven R A SimoensDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.ORCID 0000-0002-9512-2005
Lorenzo DagnaIRCCS San Raffaele Scientific Institute, Universita Vita-Salute San Raffaele, 20132 Milan, Italy.
Richard MacaulayAccess Consulting, Parexel International, Uxbridge UB8 ILZ, UK.
Beenish MajeedAccess Consulting, Parexel International, Uxbridge UB8 ILZ, UK.
Jeffrey LemayAmgen Inc., Thousand Oaks, CA 91320, USA.
Jane HippenmeyerAmgen Inc. Europe GmbH, CH-6343 Rotkreuz, Switzerland.
Sebastian Gonzalez-McQuireAmgen Inc. Europe GmbH, CH-6343 Rotkreuz, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBiosimilars 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.

methodsThe 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.

resultsParticipants 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.

conclusionsA 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.

Indexed as

biosimilar marketbiosimilar/supply and distributionbiosimilar sustainabilityDelphi technique

Identifiers

PMID33213079
PMCPMC7698572

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.