Real world data about biosimilars: results from an Italian distributed network

Category: Review Article
Author(s): , , ,
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Keywords: Italy, real world data

In recent years, drug expenditures of National Health Systems have grown significantly due to the marketing of high-cost molecules, including biological drugs. Biosimilars contain the active substance of an approved biological drug (reference product) and are comparable, effective and safe alternatives to their reference products, providing at least 20-30% purchase cost reduction. The Italian Ministry of Health funded the project “Assessment of short and long term risk-benefit profile of biologics through healthcare database network in Italy”, aimed at creating an Italian database network, involving six centres, to evaluate the pattern of use, comparative effectiveness and safety of biological drugs and biosimilars. Beyond the mentioned project, further studies were conducted using Italian administrative databases to explore the switching pattern of biosimilars and originators and the clinical consequences of switching.Considering biosimilar uptake, an increasing trend in biosimilar use was observed, despite a remarkable heterogeneity across the Country. During the first year of treatment, switching between drugs of the same class was common, occurring mostly between originators, thus suggesting that switch was not influenced by drug cost or by comparability exercise evidence. Focusing on biosimilars and originators erythropoiesis-stimulating agents (ESAs), despite a comparable effectiveness in terms ofthe hemoglobin levels gained after treatment beginning, around 20% of ESA users had a baseline hemoglobin level higher than recommended, and almost 40% achieved a hemoglobin value higher than 12g/dL, thus possibly reflecting an inappropriate ESA use. Given the expected growing number of biosimilars, a combination of multiple healthcare databases from several Countries may represent an opportunity for post-marketing monitoring of biological drugs.

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