Biosimilars use in Italy increasing

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A study of the use of biosimilars in four large Italian geographic areas has found that the use of biosimilar erythropoiesis-stimulating agents (ESAs), especially in naïve patients, increased significantly during the years 2009–2013 [1].

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Researchers from health departments and universities across Italy came together to carry out an observational, retrospective drug utilization study for the years 2009–2013. The aim of the study was to find out how different health policy interventions promoting the use of biosimilars have affected the use of ESAs in four large Italian geographic areas. Data was collected from the administrative databases of the Tuscany region and of the Caserta, Palermo, and Treviso Local Health Units (LHUs). The characteristics, prevalence, and switching patterns of different ESAs (biosimilars and reference products), stratified by indication for use, were calculated over time and across centres.

Biosimilar ESAs, such as epoetin alfa and zeta, have been authorized in the European Union since 2007 [2]. In the US, however, the first biosimilar [Zarxio (filgrastim)] was only recently approved by the US Food and Drug Administration (FDA) in March 2015 [3]. Epoetin alfa, which is mainly indicated to treat anaemia associated with either chronic kidney disease or chemotherapy in cancer patients, is one of a few biologicals (in addition to filgrastim, somatropin and soon infliximab) for which biosimilars are currently available in Italy.

In Italy, healthcare policies can be included in regional regulations. In 2009, Campania (which includes the Caserta LHU) was the first region in Italy to impose use of biosimilars for first choice treatment of naïve patients. This was followed by Tuscany and Veneto (which includes the Treviso LHU) in 2010 and Sicily (which includes the Palermo LHU) in 2014.

The study found that during the period studied (2009–2013), 49,491 patients (about 10% of the Italian population) were treated with ESAs in the four centres. Of these, 41,286 patients (83.4%) were naïve users, i.e. ESA users without any ESA dispensing in the year prior to the index date. The prevalence of ESA use increased from 2.9 to 3.4 per 1,000 inhabitants in the years 2009–2011 but decreased thereafter (3.0 per 1,000 in 2013).

The proportion of biosimilar users increased overall from 1.8% in 2010 to 33.6% in 2013, with much larger increases in Treviso (from 0.0 to 45.0%) and Tuscany (from 0.7 to 37.6%) than in Caserta (from 7.5 to 22.9%) and Palermo (from 0.0 to 27.7%).

Switching between different ESAs during the first year of therapy was frequent (17.0%), and was directed much more towards reference products (84.1% of total switches) than towards biosimilars (15.9%).

In 2009, Campania (Caserta) was the first Italian region to issue healthcare policy interventions promoting biosimilar use in naïve patients. This, according to the authors, probably explains the much higher proportion of ESA users treated with biosimilars in Caserta compared to the other three centres (Treviso, Palermo and Tuscany) in 2010. However, larger increases in the proportions of biosimilar users were found in Palermo, Treviso and Tuscany in the following years. This may be explained by stringent recommendations for biosimilars use in routine care, such as making it mandatory for ESA prescribers to document the reason why a drug other than a biosimilar is chosen, which were introduced in Tuscany and Veneto in 2010, but only in 2012 and 2014 in Campania and Sicily.

The authors concluded that differences in biosimilars use between the different regions were ‘likely as a result of heterogeneous health policy interventions’.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Related article
Biosimilars policies in Italy

1.   Ingrasciotta Y, Giorgianni F, Bolcato J, et al. How much are biosimilars used in clinical practice? A retrospective Italian population-based study of erythropoiesis-stimulating agents in the years 2009-2013. BioDrugs. 2015;29(4):275-84.
2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from:
3.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from:

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