The expected benefits of biosimilar drugs (a lower price and a competition effect on originators' price) offer an opportunity to contain the rising trend of the hospital pharmaceutical expenditure. This paper reviews the characteristics of biotechnological products and their regulatory features with the aim to evaluate if and how biosimilars are substituting the originators in the respective markets.
Specifically, the study is focused on the two biologics markets ESA and G-CSF, because of their utilization and growth rate. The observation area includes five European countries (France, Germany, Italy, Spain, and UK) and the observation period encompasses the early years of the ESA/G-CSF biosimilars marketing in such area (2008–2011). Analytical sales data at package level were collected and converted to IU (ESA) or mcg (G-CSF).
While the ESA total market (originators + biosimilars) did decline during the period and in the whole area under investigation (173 billion IUs in 2008 vs 158.1 billion in 2011), the biosimilars market alone soared (from 3.1 billion IUs in 2008 to 14.7 billion in 2011). So, a substitution effect did effectively occur, even if modest in relative terms (the biosimilars share of the total ESA market was only 8.5% in 2011). With reference to ESA biosimilars, the highest growth rate was in Italy and the largest market was in Germany.
The overall G-CSF market grew from 2.7 million mcgs in 2008 to 3.4 million in 2011. However, biosimilars alone grew at a much higher speed (from 2.5 thousand mcgs to 432.3 thousand), implying a substitution effect similar to ESA's. G-CSF biosimilars market share in Italy ranked second in the five countries area.
The substitution process of originators by biosimilars (at least in the markets, period and area observed in this study) appears relatively slow, mainly because of clinical reasons (only similarity, not therapeutic equivalence with originators, is acknowledged to biosimilars). However, the favorable impact of biosimilars on prices of, and expenditure for, biologic drugs cannot be denied.