Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan

<b>Background</b>: Biosimilars represent a fundamental advancement in global healthcare, offering significant cost containment while maintaining both therapeutic efficacy and safety in the management of chronic diseases. The cost savings generated by adopting biosimilars could be reinves...

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Main Authors: Renata Maria Bianca Langfelder, Roberto Langella, Cinzia D’Angelo, Claudia Panico, Sarah Cattaneo
Format: Article
Language:English
Published: MDPI AG 2025-03-01
Series:Pharmaceuticals
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Online Access:https://www.mdpi.com/1424-8247/18/4/482
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author Renata Maria Bianca Langfelder
Roberto Langella
Cinzia D’Angelo
Claudia Panico
Sarah Cattaneo
author_facet Renata Maria Bianca Langfelder
Roberto Langella
Cinzia D’Angelo
Claudia Panico
Sarah Cattaneo
author_sort Renata Maria Bianca Langfelder
collection DOAJ
description <b>Background</b>: Biosimilars represent a fundamental advancement in global healthcare, offering significant cost containment while maintaining both therapeutic efficacy and safety in the management of chronic diseases. The cost savings generated by adopting biosimilars could be reinvested to foster innovation in the healthcare sector and enhance patient access to advanced therapies. <b>Methods</b>: A comprehensive analysis was conducted within an Italian healthcare organization which, through its hospital network, serves over 3.5 million individuals. Usage patterns, expenditure, and patient coverage for the principal biosimilar agents across various therapeutic areas were examined. Data were extracted from institutional registries, and a year-over-year comparison from 2022 to 2024 was performed to evaluate trends in consumption, biosimilar adoption among treatment-naïve patients, incurred costs, potential and actual savings, as well as therapeutic switching profiles. <b>Results</b>: The analysis revealed a marked shift towards biosimilar formulations for the majority of the evaluated biological agents between 2022 and 2024. However, for certain active substances, a reduced market penetration of biosimilars was observed, and critical issues persist that will necessitate future interventions. <b>Conclusions</b>: The results demonstrate a consistent upward trajectory in biosimilar adoption, underscoring significant progress toward their integration into routine clinical practice—a transition that has generated substantial savings over the three-year period considered. Assuming a complete transition to biosimilars, the cumulative potential savings over the three-year period would amount to EUR 7,172,372.99 in 2022, EUR 6,209,289.05 in 2023, and EUR 23,536,824.05 in 2024. This trend aligns with strategic objectives to enhance the sustainability of the Italian National Health Service (SSN) through optimized resource allocation and improved patient access.
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spelling doaj-art-02ca555ad9bb4ab68b550342d1318b9c2025-08-20T03:13:55ZengMDPI AGPharmaceuticals1424-82472025-03-0118448210.3390/ph18040482Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of MilanRenata Maria Bianca Langfelder0Roberto Langella1Cinzia D’Angelo2Claudia Panico3Sarah Cattaneo4Pharmaceutical Department, Health Protection Agency of the Metropolitan City of Milan, 20122 Milan, ItalyPharmaceutical Department, Health Protection Agency of the Metropolitan City of Milan, 20122 Milan, ItalyPharmaceutical Department, Health Protection Agency of the Metropolitan City of Milan, 20122 Milan, ItalyPharmaceutical Department, Health Protection Agency of the Metropolitan City of Milan, 20122 Milan, ItalyPharmaceutical Department, Health Protection Agency of the Metropolitan City of Milan, 20122 Milan, Italy<b>Background</b>: Biosimilars represent a fundamental advancement in global healthcare, offering significant cost containment while maintaining both therapeutic efficacy and safety in the management of chronic diseases. The cost savings generated by adopting biosimilars could be reinvested to foster innovation in the healthcare sector and enhance patient access to advanced therapies. <b>Methods</b>: A comprehensive analysis was conducted within an Italian healthcare organization which, through its hospital network, serves over 3.5 million individuals. Usage patterns, expenditure, and patient coverage for the principal biosimilar agents across various therapeutic areas were examined. Data were extracted from institutional registries, and a year-over-year comparison from 2022 to 2024 was performed to evaluate trends in consumption, biosimilar adoption among treatment-naïve patients, incurred costs, potential and actual savings, as well as therapeutic switching profiles. <b>Results</b>: The analysis revealed a marked shift towards biosimilar formulations for the majority of the evaluated biological agents between 2022 and 2024. However, for certain active substances, a reduced market penetration of biosimilars was observed, and critical issues persist that will necessitate future interventions. <b>Conclusions</b>: The results demonstrate a consistent upward trajectory in biosimilar adoption, underscoring significant progress toward their integration into routine clinical practice—a transition that has generated substantial savings over the three-year period considered. Assuming a complete transition to biosimilars, the cumulative potential savings over the three-year period would amount to EUR 7,172,372.99 in 2022, EUR 6,209,289.05 in 2023, and EUR 23,536,824.05 in 2024. This trend aligns with strategic objectives to enhance the sustainability of the Italian National Health Service (SSN) through optimized resource allocation and improved patient access.https://www.mdpi.com/1424-8247/18/4/482biological drugsbiosimilarsoriginatorcost-containment strategytherapeuticsustainability
spellingShingle Renata Maria Bianca Langfelder
Roberto Langella
Cinzia D’Angelo
Claudia Panico
Sarah Cattaneo
Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan
Pharmaceuticals
biological drugs
biosimilars
originator
cost-containment strategy
therapeutic
sustainability
title Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan
title_full Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan
title_fullStr Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan
title_full_unstemmed Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan
title_short Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan
title_sort ensuring sustainability in pharmaceutical care a retrospective analysis of administrative databases on the utilization costs and switching patterns of biological therapies in the agency for health protection of the metropolitan area of milan
topic biological drugs
biosimilars
originator
cost-containment strategy
therapeutic
sustainability
url https://www.mdpi.com/1424-8247/18/4/482
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