Biosimilars In The European Market

Introduction and study objectives: To describe the development of biosimilars in 24 European Union (EU) Member States, plus Norway and Switzerland, and to identify the key parameters associated with biosimilars market dynamics across EU Member States.Methods: A quantitative analysis of the EU biosimilar market from 2007 to 2010 was conducted. Data were obtained from the European Medicines Agency (EMA) and the IMS MIDAS database, which include for each EU Member States: date of market entry of all biosimilars authorized by EMA up to 31 December 2010 and their respective reference products, unit sales, prices and market value of existing biosimilars and their respective reference products. The variables used to characterize market dynamics were: 1) time period between EMA's approval and market entry; 2) market share; 3) market exclusivity period. The analysis also explores whether country differences in the former variables are associated with characteristics such as pharmaceutical policies applied, demographics and economic factors.Results: The market share of biosimilars for the three reference molecules (somatropin, epoietin and filgrastim) rose from 0.33% (2007) to 15.52% (2010). Faster biosimilar launches were explained by generics price control policy, countries' gross national income and expenditure on health, pharmacists' generics substitution and medicines' price level index.Conclusion: Biosimilars may help lower the cost of biological medicines. Existing EU evidence is still limited and results show no clear pattern of market dynamics, although it is likely that biosimilars will result in smaller price reductions and lower market share than conventional generics.