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Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection
Jaime Espin1,2,3, Zuzana Špacírová4,5, Leticia García-Mochón1,2,3
1Andalusian School of Public Health/Escuela Andaluza de Salud Pública (EASP), Granada, Spain.
Biosimilar medicine use in Spain rose significantly from 9% in 2016 to 47% in 2023. Hospital settings and acute condition biosimilars showed higher uptake, with more competitors boosting market share in hospitals.
Area of Science:
- Pharmacoeconomics and Health Policy
- Drug Utilization Research
- Biopharmaceutical Market Analysis
Background:
- Limited public data on biosimilar uptake exists in most European countries, hindering comprehensive analysis.
- Spain lacks regularly published nationwide data on biosimilar consumption and market penetration.
Purpose of the Study:
- To conduct a nationwide assessment of biosimilar consumption and uptake patterns in Spain from 2016 to 2023.
- To analyze factors influencing biosimilar market share, including setting, indication type, and competitor numbers.
Main Methods:
- Utilized nationwide data on biosimilar defined daily doses (DDD) dispensed via community pharmacies and hospitals.
- Employed non-parametric tests and bootstrap analysis (10,000 replications) to analyze market share, time since entry, competitor count, and indication type.
- Included data on bio-originator and biosimilar registration status for each active principle.
Main Results:
- Biosimilar penetration in Spain increased from 9% in 2016 to 47% in 2023.
- In 2023, hospital settings showed higher biosimilar market share (68%) than community pharmacies (34%).
- Biosimilars for acute conditions had higher market shares than those for chronic conditions; a positive correlation between market share and competitor numbers was significant in hospitals.
Conclusions:
- Biosimilar utilization in Spain has grown substantially, with significant differences between hospital and community pharmacy settings.
- The type of condition treated (acute vs. chronic) and the number of competitors influence biosimilar market share, particularly in hospitals.
- Further research into policies promoting biosimilar adoption is recommended to optimize their use in Spain.
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