Many European healthcare systems have struggled to fund biologic therapies for the numerous patients who need them, and cost containment in this area has been recognized as a priority by the European Commission (EC). The European Medicines Agency (EMA) has led the world in the development of regulatory guidelines for the development and assessment of biosimilars, establishing key principles of comparability that have been adopted by many other regions around the world.
2016 marked the tenth anniversary of the launch of the first biosimilar in Europe and Medicines for Europe claimed1:
The European biologic market is growing at an annual rate of approximately 5.5%. By comparison, the total pharmaceutical market growth in Europe between 2012 and 2013 was 1.9%. By late 2014, biologic medicines accounted for 27% of pharmaceutical sales in Europe.2
Although biologics have transformed clinical outcomes for patients throughout Europe, their high cost has put a heavy strain on European healthcare systems. The European Commission has stated that the cost of biologics compared with small-molecule medicines is a challenge for most payers.3 For example:
"Price – just as much as safety and efficacy – has proved a hot topic for nearly 20,000 oncology experts at the European Society for Medical Oncology (ESMO) 2014 congress in Madrid." 13
The EMA approved its first biosimilar – a biosimilar of somatropin (growth hormone) – in 2006 and has accumulated over a decade of real-world experience with biosimilars. As of 2017, the EU remains significantly ahead of other highly regulated markets in terms of the total number of biosimilar products approved, although this total does include several biosimilar versions of the same originator (e.g. filgrastim) in some cases.15 An up-to-date record of EMA-approved biosimilars can be found here. European experience with biosimilars since they were first introduced in 2006 has revealed no reports of untoward effects or unexpected adverse events compared with the originator biologics.3
Biosimilars are now in clinical use across almost all EU member states. Uptake was fairly slow initially due to their unfamiliarity but has since begun to accelerate.
Figure 1: Biosimilar sales across the EU5
Source: IMS Health, MIDAS, MAT Dec 2013
Current differences in the use of biosimilars and competition dynamics across European markets mainly reflect local adoption of treatment practices and guidelines influenced by funding decisions and payer actions.2
The European Commission expects several new classes of biosimilar medicines to be submitted for approval in Europe in the coming years.3 A number of ‘blockbuster’ biologics are expected to lose their EU patents before 2020, including leading treatments for breast cancer, diabetes, multiple sclerosis and rheumatoid arthritis.35,36 The opportunities for clinical investigators in biosimilar research are expected to escalate throughout Europe.