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Article History

Accepted: 18 March 2025

First Online: 3 April 2025

Declarations

:

: Open access funding provided by Università degli Studi di Verona within the CRUI-CARE Agreement. This study was funded by the Italian Medicines Agency in the context of the multiregional pharmacovigilance project (AIFA 2012–2014: 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—VALORE project). The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

: G.T. participated in advisory boards and seminars as lecturer on topics not related to the paper and was sponsored by the following pharmaceutical companies in the last 2 years: Eli Lilly; Sanofi; Amgen; Novo Nordisk; Sobi; Gilead; Celgene; Daiichi Sankyo; Takeda; and MSD. He is also scientific coordinator of the pharmacoepidemiology team at the University of Verona and of the academic spin-off “INSPIRE S.r.l.” that in the last 2 years carried out observational studies/systematic reviews on topics not related to the content of this article and which were funded by PTC Pharmaceutics, Kyowa Kirin, Shionogi, Shire, Chiesi, and Daiichi Sankyo. Y.I. is the CEO of the academic spin-off “INSPIRE S.r.l.,” 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 datasets generated and/or analyzed during the current study are not publicly available because of privacy reasons. Requests to access the datasets should be directed and motivated to the corresponding author.

: Not applicable.

: F.S., A.S., G.C., and G.T. contributed to the writing of the article and methodology; G.P. and C.M., contributed to the conduction of the analysis; S.A.M.U and A.C. contributed to data interpretation; C.B., L.L., Y.I., O.L., M.Z., 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.S., A.A., S.A.P, R.D.C., G.B., A.M.P.M, F.B., C.S., I.S., M.T., R.G., S.S.A., and M.M. contributed to data extraction and data interpretation. All the authors reviewed the final version of the article.

: This study was conducted in the context of the multiregional active pharmacovigilance project called Post-marketing evaluation of the benefit–risk 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—VALORE project, funded by the Italian Medicine Agency. The study protocol was registered in the HMA-EMA catalogue of real-world data sources and studies (EUPAS1000000211), and the ethical committees of the Academic Hospitals of Messina and Verona approved it.

: Not applicable.

: Not applicable.