Evidence mapPaperPMID 40888284Full record

ArticleDiabetes, obesity & metabolism2025

Barriers to adoption of biosimilar insulins in Europe: A mixed-methods study.

Elif Car, Garm Habets, Arnold G Vulto, Lutz Heinemann, Isabelle Huys, Steven Simoens

Abstract read
In one paragraph

Article in Diabetes, obesity & metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
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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

6 authors.

Elif CarDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0003-4356-4722
Garm HabetsDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Arnold G VultoDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0002-8439-2800
Lutz HeinemannScience-Consulting in Diabetes GmbH, Düsseldorf, Germany.ORCID https://orcid.org/0000-0003-2493-1304
Isabelle HuysDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0002-4738-8298
Steven SimoensDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0002-9512-2005

Funding

KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL Fund)
6 · The paper itself

Abstract

backgroundDespite the introduction of biosimilar insulins to improve affordability and enhance patient access, their adoption remains limited in Europe.

objectivesThis study aims to (i) provide an up-to-date overview of EMA-approved insulin products and their reimbursement status across selected European countries, and (ii) explore the key factors influencing physicians' prescribing decisions regarding biosimilar and originator insulin.

methodsA mixed-method design was applied, comprising (i) a quantitative analysis of EMA-approved insulin products and their reimbursement status in nine European countries, and (ii) semi-structured interviews with physicians (N = 20).

resultsBetween 1996 and 2022, 43 insulin products received EMA approval, including six biosimilars (14.0%). Over 95% of approvals originated from three manufacturers: Novo Nordisk (39.1%), Sanofi (32.6%) and Eli Lilly (23.9%). Across the nine European countries, an average of 56.3% of EMA-approved insulin products, including biosimilar insulins, were reimbursed, ranging from 71.7% in the Netherlands to 41.3% in Belgium. The proportion of originator and second-generation insulin analogs was consistently higher than that of biosimilar insulins. In the qualitative phase, six thematic domains influencing physician prescribing choices for insulin products were identified, encompassing a total of 14 distinct factors. Prominent domains included (i) product-related (second-generation insulin analogs, and drug-device compatibility), (ii) pharmaceutical industry-related (company reputation trustworthiness, and marketing activities) and (iii) physician-related factors (habit persistence).

conclusionThis study highlights interrelated factors contributing to the limited adoption of biosimilar insulin in Europe. Addressing these barriers through targeted policy interventions may support more informed decision making and facilitate biosimilar insulin adoption in the future.

Indexed as

Biosimilar PharmaceuticalsHypoglycemic AgentsInsulinPractice Patterns, Physicians'Drug ApprovalEuropeFemaleHumansBiosimilar PharmaceuticalsHypoglycemic AgentsInsulinbiologicsbiosimilar insulindiabetesinsulin analogsmarket dynamicsuptake

Identifiers

PMID40888284
PMCPMC12515786

What Socratic holds

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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 Socratic graph.