Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

Since the first biosimilar medicine, Omnitrope® (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized Spain. We estimate budget impact of Spain from perspective National Health System (NHS) over period between 2009 and 2019. Drug acquisition costs considering commercial discounts at public procurement procedures (hospital tenders) uptake data for both originator as actual units consumed by NHS were two variables considered. Two scenarios compared: a scenario where no are available effectively marketed. All molecules exposed to competition during this included analysis. The robustness model tested conducting multiple sensitivity analyses. From payer perspective, it is estimated that savings produced adoption would reach EUR 2306 million 11 years corresponding cumulative all biosimilars. Three (infliximab, somatropin epoetin) account 60% savings. This study provides estimation financial Spain, effect manufacturers give hospitals growing market share our last year data, 2019, derived use relative total pharmaceutical spending 3.92%. Although more research needed, evidence supports case represent great opportunity sustainability through rationalizing full potential biosimilar-savings has not achieved yet, there high variability across autonomous regions.