The VALORE project: the Italian multi-database network for post-marketing surveillance of biologics and biosimilars
Moderator: Jessica Jalbert
Speaker: Gianluca Trifiro, FISPE
Description: The COVID-19 pandemic and the potential role of biologics as either risk factors for SARS-COV-2 infection or as COVID-19 treatments highlighted the importance of setting up a data infrastructure for the rapid generation of real-world evidence (RWE) on biologics in the context of a healthcare emergency.
VALORE is a project funded by the Italian Drug Agency that is aimed at setting up a national network by integrating data from regional claims databases, clinical registries, and prospectively collected data via active surveillance with ultimate goals of:
• Assessing prescribing appropriateness and short-/long-term effectiveness and safety of biologics and biosimilars in a real-world setting across therapeutic areas (dermatology, rheumatology, gastroenterology, and onco-hematology);
• Exploring the interchangeability of reference biologics and biosimilars;
• Setting up a national network to generate RWE on biologics that will be used to educate Italian healthcare professiona