Study identification

PURI

https://redirect.ema.europa.eu/resource/50140

EU PAS number

EUPAS50139

Study ID

50140

Official title and acronym

Switch pattern of biological drugs (originator and biosimilars) for the treatment of chronic immune-mediated inflammatory diseases through an Italian network of regional administrative databases: the VALORE Project

DARWIN EU® study

No

Study countries

Italy

Study description

In September 2022 EMA stated that biosimilars are comparable to their reference products in terms of safety and immunogenicity and are therefore interchangeable. However, for a single active ingredient numerous biosimilars are marketed and switching patterns among biological drugs might be very various and complex. The aim of this study is to describe the pattern of switch and swap among incident users of biological drugs approved for IMIDs in dermatology, rheumatology, and gastroenterology. A retrospective cohort study will be conducted using the claims data of nine Italian regions from 2010 to 2020 (VALORE project). Incident users of biologic drug with an indication for IMIDs will be included. Characteristics of patients, pattern of switch and swap among biological drugs with related predictive factors will be described by therapeutic indication. We are confident to finalize the results of this study by the end of March 2023.

Study status

Finalised
Research institution and networks

Institutions

Azienda Zero Veneto, Italy, Epidemiologic Observatory of the Sicily Regional Health Service Palermo, Sicilia, Italy, Territorial Assistance Service, Drug and Medical Device Area, Emilia Romagna Health Department Bologna, Emilia Romagna, italy, Azienda Regionale per l'Innovazione e gli Acquisti, S.p.A Milano, Lombardia, Italy, Apulian Regional Health Department Bari, Apulia, Italy, Unit of Adverse Drug Reaction Monitoring, University Hospital of Pisa Pisa, Toscana, Italy, Direzione Centrale Salute Regione Friuli Venezia Giulia Trieste, Friuli Venezia Giulia, Italy, Azienda regionale di coordinamento per la salute (ARCS) Udine, Friuli Venezia Giulia, Italy, Hospital Pharmacy Unit, Trento General Hospital Trento, Autonomous Province of Trento, Italy, Azienda Provinciale per i Servizi Sanitari Trento, Autonomous Province of Trento, Italy

Networks

VALORE

Contact details

Gianluca Trifirò

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Agenzia Italiana del Farmaco (AIFA)
Study protocol
Initial protocol

221206_Valore_Switch_protocol

English (1.3 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable