Towards a sustainable European Market for Off-Patent Biologics:  

Biologic medicines have revolutionized the treatment of many life-threatening illnesses such as cancer and autoimmune diseases as well as many rare diseases. Many biologic products can actually slow the progress of or even prevent disease, leaving healthy cells unaffected and generally causing fewer side effects. As technology advances and major biologic products are no longer under exclusivity, follow-on products have begun expanding the biologics market considerably. Yet because of their intricate molecular structure and complex manufacturing process in living cells, unlike generic follow-on products to traditional chemical entities, the production and manufacturing process of biosimilars cannot guarantee that the followon product’s properties are identical to those of the reference product. For this reason, follow-on products of innovative biologic medicines are referred to as biosimilars. Europe and the EU have historically been pioneers with regards to the regulatory approval and use of biosimilars – being the first to develop a biosimilar pathway in 2003 and the first to approve a biosimilar for marketing in 2006 – and is now reaping the economic benefits, with increased availability of biological treatments at lower prices. At the same time, Europe maintains its lead role in fostering innovation, with more than 12,000 clinical trials on biologic medicines conducted in Europe to date, and a steady growth of biologic clinical trials activity at an average Compounded Annual Growth Rate (CAGR) of 7% between 2010 and 2015 within the EU-5 countries. With increased patient access and healthcare system efficiencies generated through competition on the one hand and continued innovation on the other, the biologics segment represents a rapidly-growing segment of the European biopharmaceutical market, whose health, social and economic impact on the European economy is significant. Securing a sustainable future for the European biologics and biosimilars market is a top priority for European countries and for the European economy as a whole.