Type 2 & other diabetes

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

Diabetes Obes MetabPublished Mixed-methods study

Authors' conclusion

This 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.

Study context

Population
EMA-approved insulin products and their reimbursement status in nine European countries; physiciansphysicians interviewed
Participants
20 participants
Outcome
EMA-approved insulin products and reimbursement; factors influencing prescribing
Follow-up
1996–2022
Methodological detailsquantitative analysis of EMA-approved insulin products and reimbursement status, semi-structured interviews
  • Quantitative analysis of EMA-approved insulin products and reimbursement status
  • Semi-structured interviews

Main finding

As reported in the abstract

1996–2022
Insulin products with EMA approval
43
Biosimilars among approvals
six (14.0%)
Approvals from Novo Nordisk
39.1%
Approvals from Sanofi
32.6%
Approvals from Eli Lilly
23.9%
Average share of EMA-approved insulin products reimbursed across nine countries
56.3%
Reimbursed share, Netherlands (highest)
71.7%
Reimbursed share, Belgium (lowest)
41.3%
Thematic domains influencing physician prescribing
six
Distinct factors
14

Original publication

Barriers to adoption of biosimilar insulins in Europe: A mixed‐methods study. Diabetes Obes Metab. Published 1 September 2025. doi:10.1111/dom.70082

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