[Biosimilars and medico-economic aspects]

Abstract

Although few molecules are available, annual total sales of biotechnology drugs amounted 71 billion $ in 2008) and knew a 17% progression per year. As traditional drugs had their generic, many biotechnology drugs had or will lose their patent and be copied, called "biosimilars" or "follows-on". According to the economic impact of biotechnology drugs, the availability of biosimilars may result in great reduction of drugs expenditure. In 2004, EMEA has set up specific rules for biosimilars, distinct from those applied to generic drugs, based on clinical research requirement and post-authorization follow-up of these drugs, and then significantly impacting on their costs of research, development and marketing. The economy generated by the availability of biosimilars should be lower than expected, even null, contrasting with those usually generated by generics. In order to better understand the medico-economic factors related to biosimilars availability, this article will described the market of the biotechnology drugs. The differences existing between generics and biosimilars and their impact on costs will be presented. Finally, it will focus on the factors that may facilitate or limit the biosimilars development and their substitution.