PHP93 Development of Biosimilar Mark in EU-5 and USA

Abstract

OBJECTIVES: Identify differences of biosimilar uptakes across the EU big five: France, Italy, Germany, UK, Spain, and USA. METHODS: We identified policies and biosimilars market shares in volume and value in EU big five: France, Italy, Germany, UK, Spain and USA. We browsed websites of EU and national (when applicable) drug agencies, ministries of health, HTA bodies, payers, manufacturer unions etc. We completed our research with literature search and grey reports, as well as Datamonitor reports, IMS data and proprietary pharmavitae database. RESULTS: Contrary to FDA, EMA has a well defined regulatory path for biosimilars. However, when the US Patient Protection and Affordable Care Act 2010 enters into force in 2014, the biosimilars market will be boosted. Today 80% of this market is in EU. While uptakes in Spain and UK have started to increase, Germany and France account currently for half of the biosimilars market by value in EU with a 36% and 19% share respectively. In UK, biosimilars have had low penetration, and in Italy the market is far behind other countries. Other countries with apparently high sales of biosimilars like Greece are source countries for parallel market. Obviously there is no overlap between the generics market size and the biosimilars one. The slow uptake versus generics can be explained by the low discount of biosimilar price versus branded products and the uncertainty about the clinical effect. CONCLUSIONS: The lack of regulatory path in USA makes difficult the launch of biosimilars. However, EU is the experimental field where companies develop their ability to capture this market. Small molecule generics continue representing the main source of cost savings in Europe. Biosimilars represent a huge opportunity for cost saving in the future especially in the USA where the biologic market is leader.