Policy recommendations for a sustainable biosimilars market: lessons from Europe

Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs of an ageing population, mean the cost of these medicines and the burden on governments and insurance companies is growing. However, the introduction of biosimilars has broadened treatment choices for physicians and their patients and, by increasing competition, reduced healthcare expenditures. The biosimilar market in Europe is the largest in the world, representing approximately 60% of the global biosimilar market and growing consistently year on year. As of October 2019, 54 biosimilars of 15 originator biological medicines have marketing authorization in Europe. European countries, with their large biosimilar markets and diverse healthcare systems, serve as valuable examples of different approaches to biosimilar policy. Several studies, research papers and position statements have been published on such policies. These findings, along with real-world policy and procurement examples from European countries, provide an opportunity for other countries to learn from. This paper will review the different approaches to biosimilar policy across the European continent, highlighting principles which can be applied to develop an efficient and sustainable biosimilar market.