CHAPTER 5: BIOSIMILARS: A REGULATORY FRAMEWORK AT THE CROSSROADSOF HEALTH SECURITY AND HEALTH ECONOMICS

Abstract

Expiration of patents for biologic drugs allows marketing of biosimilars as copies of reference biologic drugs. The major benefit of biosimilars for health systems relies on thefact that they are likely to bring progress in terms of efficiency and accessibility. Their legal framework is mixed: European for quality, efficiency and safety; national for socio-economic characteristics. At the European level, our analysis highlights a legal and political corpus generally favorable to the development of biosimilars, despite both organizational and structural limits. In France, decisions related to refund, prices and use of biosimilars reveal hesitations between health and economic issues. Ten years after the of the first biosimilars were licensed, national and European policies result in uncertainty for each stakeholder, respectively on profitability for industrials, efficiency for payers, and risk/benefit ratio for users (healthcare professionals and patients).