État des lieux de la réglementation relative à la prescription et à la délivrance des médicaments biosimilaires, analyse des politiques de santé, des enjeux économiques et des stratégies industrielles mises en œuvre pour favoriser leur développement

Abstract : Biological drugs have been at the heart of therapeutic innovation for more than 20 years. They became essential and accounted for more than 20% of drug sales in France in 2017. With the fall of patents, the market of biological drugs opens to the competition of "copies" called biosimilars. Their economic interest is the same as generic drugs: to allow patients access to treatments as effective and safe as the reference treatment but at a reduced cost. However, because of their structure and their specific production process, biosimilars cannot be considered generics and require a specific regulatory framework for their marketing authorization, prescription and dispensing. The analysis of the first experiences with these products in the European Union shows that France is reluctant to adopt them. This thesis aims to understand the economic issues that biosimilars represent and how health policies and industry work to promote their development.
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Master Thesis
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Pauline Brault. État des lieux de la réglementation relative à la prescription et à la délivrance des médicaments biosimilaires, analyse des politiques de santé, des enjeux économiques et des stratégies industrielles mises en œuvre pour favoriser leur développement. Sciences pharmaceutiques. 2018. ⟨dumas-02115571⟩

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