PHP217 - TIME TO MARKET AND PRICE COMPARISON FOR BIOSIMILAR DRUGS IN EU5

Abstract

To compare the time elapsed from European Medicines Agency (EMA) authorisation to national commercialization and price differences of biosimilar drugs in five European countries (EU5). The panel is constituted by authorized biosimilars, extracted from EMA website. Commercialization dates in each country were collected through the official sources. Differences from EMA authorisation to national commercialization were evaluated. In addition, variations in drug prices between the EU5 were assessed considering ex-factory prices. For each country, official price sources were consulted for the respective prices (2018 €). From April-2006 to January-2018 EMA authorized 39 biosimilars for 15 active substances. It was observed that some 33% (n=13) of the total biosimilars authorized had not been commercialized yet in at least one of the EU5 countries, in some cases due to existing patents. 36% (n=14) of the biosimilars authorized have been launched in all EU5 countries. For biosimilars with an available commercialization date for all EU5, the median time elapsed from EMA authorisation to national commercialization was 4.47 months (range 0.13-27.35) in the UK; 5.85 months (range 0.72-25.15) in Germany; 8.58 months (range 4.31-26.70) in Spain; 13.48 months (range 5.42-31.73) in France and 15.32 months (range 6.54-35.08) in Italy. High variations on the average price were observed for some of the biosimilars launched in all EU5. The joint analysis of EU5 is important in order to understand differences of market access processes across countries and implement strategies accordingly. The analysis has considered the country regulation and a variability in access and prices of approved biosimilars in different EU5 countries has been found.