Regional tenders on biosimilars in Italy: an empirical analysis of awarded prices.

OBJECTIVE: The goal of the present study is to assess the awarded prices and thus the real level of competition the regional tenders referring to biosimilars in Italy achieved.

METHODS: We conducted a web-based analysis to collect detailed information on regional biosimilar tenders, up to December 2012. We identified 191 lots referring to the three off-patent biologicals (somatropin, epoetin and filgrastim) mentioned in the 24 tenders that took place during the study period (2008-2012). A multiple linear regression analysis was conducted to assess the relationship between prices awarded (dependent variable) and potentially explanatory variables (base quantities, bioagent, number of competitors, purchasing region and time).

RESULTS: While the price of somatropin stayed steady, those of filgrastim and epoetin dropped steeply. The mean number of competitors was lowest for somatropin and highest for filgrastim. One additional competitor was associated with about a 10% reduction in the price on average. The benefits of having many competitors did not fade with increasing numbers of companies.

DISCUSSION: Our analysis confirms the theory that worthwhile savings can be generated in tenders, once the bid is designed in such a way that competition can produce its effects, i.e. allowing more than one manufacturer to tender. However, most of the Italian regional tenders on off-patent bioagents do not seem to exploit potential competition to the full.