OBJECTIVES: Biosimilars drugs are an opportunity for all healthcare systems. Their arrival allows to reduce financial charges borne by the healthcare service, ensuring a broader access to innovation for all patients and the same therapeutic effects. We aimed to investigate the impact of the pharmaceutical legislation implemented between 2010 and 2018 in Italy to enhance the market penetration of biosimilars.

METHODS: This study compares biological and biosimilar medicinal products’ utilization within the Italian market, retrospectively. This analysis was focuses on data in Italy from 2010 to 2018. Biosimilar and originator products were divided into three waves. Drug consumption was expressed in terms of Minimum Divisible Unit (UMF). The market penetration of biosimilar drugs was analyzed by year and quarterly. Furthermore, the penetration of biosimilars was analyzed following the issue of two Position Papers published by AIFA and the Budget Low no. 236/2016.

RESULTS: At a national level, following enactment of several pharmaceutical legislation, there was a steady increase penetration of biosimilar medicinal products. Overall, biosimilar drugs use was greater in the North than in the South of Italy. For the first wave, percentage rate of biosimilars penetration after the publication of the Italian Budget Law no. 232/2106 has reached 44%. Following the publication of the 2nd Position Paper published by AIFA, the penetration of biosimilars is further increased (65%). For the second wave, following the publication of the 2nd AIFA Position Paper biosimilars penetration was raised from 14% in 2017 to 52%, overcoming the corresponding originators use. For the third wave, the biosimilar penetration increased from 10% to 32% during 2018.

CONCLUSIONS: This study showed that national positions and regulations represents an effective driver of biosimilar market penetration. Notably, the uptake of biosimilars is heterogeneous among different therapeutic classes and among different Italian geographical areas.