État des lieux des réflexions et des perspectives autour des biosimilaires en France

Abstract : The year 2015 marked the launch of monoclonal antibody biosimilars. Biotherapeutic medicines such as Enbrel®, Humira®, Mabthera® cost more than hundreds millions euros to the National Health Insurance. They are now about to be challenged by face competition from their biosimilars. The economic stake represented by the development of biosimilars in France is also a major issue for the National Health Insurance. Nevertheless, the biosimilar market, although still immature, is highly dynamic. The cumulative potential savings that can be generated by the arrival of biosimilars, should allow resources to be oriented towards costly pharmaceutical innovation. Barriers to the acceptance and prescription of biosimilars are still numerous among physicians and patients. They are mainly due to the lack of information, knowledge and transparency on the development, traceability and demonstration of the therapeutic equivalence of biosimilars with their reference biological medicinal product. Public authorities should adopt policies favoring the access to biosimilars by removing obstacles to their prescription. The recommendation presented in this thesis should provide tools for the development of a new policy in favor of the use of biosimilars by acting on healthcare professionals, medical organizations, and health technology assessment bodies at a national and local level.
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Master Thesis
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Baptiste Henrion. État des lieux des réflexions et des perspectives autour des biosimilaires en France. Sciences pharmaceutiques. 2017. ⟨dumas-01626368⟩

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