Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European risk management plans.

Background And Aims: Biosimilars have been available in the European Union (EU) since 2006. However, their uptake in routine care is heterogeneous across countries. The aim of the present study was to compare the safety information of biosimilars and their originators based on the information in the European risk management plan (RMP).

Kounis Syndrome: An analysis of spontaneous reports from international pharmacovigilance database.

Introduction: The coincidental occurrence of a cardiac symptomatology (e.g. an acute coronary syndrome or a myocardial infarction), during an anaphylactic or anaphylactoid episode is known as Kounis Syndrome.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): A National Analysis of Data from 10-Year Post-marketing Surveillance.

Introduction: Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare, severe and potentially fatal cutaneous adverse drug reaction (the mortality rate is up to 10 %) associated with numerous and apparently heterogeneous drugs. The aetiology is unknown.

Objective: To report Italian cases of DRESS over a 10-year period.

Drug-induced anaemia: a decade review of reporting to the Italian Pharmacovigilance data-base.

Background: Studies investigating drug-induced anaemia are relatively scarce and mostly related to specific drugs or patients with specific pathologies.

Objective: To analyse all reports of suspected drug-induced anaemias recorded in the National Pharmacovigilance Database of the Italian Medicines Agency.

Method: The cases of suspected drug-induced anaemias analysed were those retrieved from the Italian National Pharmacovigilance Database from January 2001 to December 2013.

Safety profile of biological medicines as compared with non-biologicals: an analysis of the italian spontaneous reporting system database.

Background: Biologicals are important treatment options for various chronic diseases. After the introduction of the first biosimilars, animated debate arose in the scientific community about the actual benefit-risk profile of these drugs. In this context, a comparative safety evaluation of biologicals and biosimilars in clinical practice is warranted.

Pharmacovigilance and the italian medicines agency.

The new European Union (EU) regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA), is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law.

Biosimilars: the paradox of sharing the same pharmacological action without full chemical identity.

The use of biotech medicines is increasing, with consequent mounting expenses for National Health Systems (NHSs). Biosimilars should be considered an opportunity to improve access to care. On the other side, the general public might suspect to receive low-quality medicines to save money.