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GaBI J. 2020. https:\/\/doi.org\/10.5639\/gabij.2020.0904.027.","journal-title":"GaBI J"}],"container-title":["Pharmaceutical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40290-026-00629-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40290-026-00629-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40290-026-00629-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T08:46:40Z","timestamp":1791449200000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40290-026-00629-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,18]]},"references-count":42,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,11]]}},"alternative-id":["629"],"URL":"https:\/\/doi.org\/10.1007\/s40290-026-00629-7","relation":{},"ISSN":["1178-2595","1179-1993"],"issn-type":[{"value":"1178-2595","type":"print"},{"value":"1179-1993","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,18]]},"assertion":[{"value":"26 July 2026","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 August 2026","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was funded by the Italian Medicines Agency (AIFA) in the context of the multiregional pharmacovigilance project (Fondi Farmacovigilanza 2012, 2013 e 2014: post-marketing evaluation of the benefit-risk profile of originator biologics and biosimilars in the dermatological, rheumatological, gastroenterological, and onco-hematological areas through the establishment of a single multiregional network for the integrated analysis of data from health databases, active surveillance, and clinical registers\u2014VALORE project).","order":1,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"G.T. has served, over the last 3 years, on advisory boards\/seminars funded by Sanofi, MSD, Eli Lilly, Sobi, Celgene, Daichii Sankyo, Novo Nordisk, Gilead, and Amgen on topics not related to content of this paper; he is also a scientific coordinator of the academic spin-off \u201cINSPIRE srl,\u201d which has received funding from several pharmaceutical companies (Kiowa Kirin, Shonogi, Shire, Novo Nordisk, and Daichii Sankyo) for conducting observational studies, and additional consultancy services on topics not related to content of this paper. In addition, he is currently a consultant for Viatris in a legal case concerning an adverse reaction to sertraline. Y.I. is the CEO of the academic spin-off \u201cINSPIRE srl,\u201d which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.), and from pharmaceutical Companies (Chiesi Italia, Kyowa Kirin s.r.l., Daiichi Sankyo Italia S.p.A.). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.","order":2,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was conducted in the context of the multiregional active pharmacovigilance project called Post-marketing evaluation of the benefit\u2013risk profile of originator biological drugs and biosimilars in the dermatological, rheumatological, gastroenterological, and onco-hematological areas through the establishment of a single multiregional network for the integrated analysis of data from health databases, active surveillance and clinical registers\u2014VALORE project, funded by the Italian Medicine Agency. The study was approved by the ethical committees of the Academic Hospitals of Messina and Verona.","order":3,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"G.V.,\u00a0L.P., A.S., and G.T. contributed to the conception, design, and writing of the study; G.P. and L.L., contributed to the conduction of the analysis; C.B., Y.I., O.L., A.M., D.A., P.S., A.C., A.S., S.L., V.B., S.L., P.C., P.R., L.E., E.S., A.P., R.F.S., G.D., A.A., S.A.P., R.D., G.B., A.M.P.M., F.B., C.S., I.S., M.T., R.G., U.T., F.F.B., F.M., S.S.A., M.M., S.A., and G.S., contributed with data extraction, and data interpretation. All the authors reviewed the final version of the article.","order":4,"name":"Ethics","label":"Author Contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The datasets generated and\/or analyzed during the current study are not publicly available because of privacy reasons.","order":5,"name":"Ethics","label":"Availability of Data and Materials","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable","order":6,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable","order":7,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable","order":8,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}}]}}