OBJECTIVES: Diverse policies and information campaigns have been launched in Italy, Portugal and Spain to support the adoption of TNF-alfa inhibitor biosimilars. Despite these measures, intra-country biosimilars uptake heterogeneity is wide, and biosimilars utilisation in certain regions is considerably below the European average. The aim of this study is to identify factors affecting TNF-alfa inhibitor biosimilars use in Southern European hospital markets.

METHODS: This is a mixed-methods study based on (1) the quantitative analysis of regional uptake data for TNF- alfa inhibitor biosimilars and (2) the qualitative processing of semi-structured interviews capturing experts’ views on biosimilars uptake determinants.

RESULTS: Despite an increased familiarity of healthcare professionals and patients with the prescription/use of TNF-alfa inhibitor biosimilars in Italy, Portugal and Spain, barriers persist that impede high biosimilars uptake, especially in populations of chronic patients eligible for a switch. The main identified barriers are: (1) the late publication of position statements on biosimilars interchangeability by regulatory health authorities; (2) the vague positioning of (national/regional) health authorities on best switching practices (including multiple biosimilar-to-biosimilar switches), (3) the existence of policy frameworks that do not necessarily support the initiation of switching protocols; (4) the establishment of sometimes inefficient purchasing procedures that limit biosimilars potential to compete for market shares. Diverse approaches taken regionally to address these barriers have contributed to heterogeneous TNF-alfa inhibitor biosimilars uptake across Southern Europe.

CONCLUSIONS: There is a need for common policy frameworks supportive of measures already implemented locally in Italy, Portugal and Spain to foster biosimilars use. These frameworks should account for the particularities of off-patent biologic and biosimilar markets, and jointly address supply- and demand-side challenges.