Abstract
ABSTRACTBackground & Objectives: Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU).Methods: A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition.Results: At the study cut-off date, 20 biosimilars were available on the market. Incentive policies applied to biosimilars were found to be heterogeneous across countries, and uptakes of biosimilars were also very heterogeneous between different therapeutic classes and countries. Results from the model demonstrated that incentive policies and the date of first biosimilar market entry were correlated to biosimilar uptake. Pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Average generic price discount over originator and the number of biosimilars showed a trend toward statistical significance for correlation with biosimilar uptake, but did not reach the significance threshold. Biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake.Conclusions: Understanding drivers of biosimilar uptake becomes a critical issue to inform policy decision-makers. This study showed that incentive policies to enhance uptake remain an important driver of biosimilar penetration, while biosimilar price discounts have no impact. Future research is warranted when the biosimilar market gains maturity.
Highlights
Background & ObjectivesPotential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches
At the time of the review, pharmaceutical prescription budgets or prescription quotas were reported in place for half of the countries [14,19,39,40,41,42,43] Financial incentives or penalties measures were found in countries applying pharmaceutical prescription budgets and/or prescription quotas, but were reported as not frequently enforced (Belgium, Germany) or enforcement was not documented in the literature (Greece, Italy, Sweden, the UK) [14,39,41,42,44]
This study showed that the number of incentive policies dedicated to enhance biosimilar uptake is an important driver of biosimilar penetration, as already suggested in qualitative studies [16,17,39,40]
Summary
Background & ObjectivesPotential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU). With the first biosimilar approved in 2006 [1], the EU is the global pioneer in the approval of biosimilars and the most developed market in this area. The biosimilar market is expected to grow substantially, as best-selling biologics are scheduled to come off-patent in the coming years (Table 2) [2,3]. In this perspective, the European Commission is actively working on the impact and promotion of biosimilar uptake within the EU through its Project Group on Market Access and Uptake of Biosimilars. The group involves EU member states (MS), European Economic Area (EEA) countries’ representatives, as well as other stakeholders such as patient organisations’ and health care professionals’ representatives, and experts [4,5]
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