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Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection.

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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.

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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.