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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43960
• EU PAS number:
  EUPAS43274
• Study ID:
  43960
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  The nationwide multiregional Italian VALORE project set up a data infrastructure integrating claims data plus clinical registries from 16 Regions with the final aim of conducting post-marketing surveillance of biologics, including biosimilar, in patients with immune-mediated inflammatory diseases.
• Study status:
  Ongoing

Research institution and networks

Institutions

Azienda Ospedaliera Universitaria Integrata Verona

Study timelines

Date when funding contract was signed

Actual: 27/11/2020

Study start date

Planned: 30/09/2021

Actual: 30/09/2021

Date of final study report

Planned: 30/07/2023

Sources of funding

Other

More details on funding

Italian Medicine Agency

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable