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Master Thesis

L’impact des politiques et des réglementations sur les biosimilaires dans l’Union Européenne, aux États Unis, en Inde, au Brésil, en Chine et en Corée du Sud

Abstract : Biosimilars are becoming an accurate subject with the increase of biological drugs and the end of the patents. It is impossible to consider biological drugs as chemical drugs. The structures are different, the size too and in order to have the same efficacy and safety for the patients, much more studies are needed. Historically the European Medicine Agency has been the first to release guidelines about biosimilars and to approved products on it market. However the aim of this work was to investigate in countries where regulation exists and see what were the differences with the European guidelines and see the different products on their market. For each country (China, India, South Korea, Brazil, UE and US), we have investigated on the economic situation of the country, the health system, we have compare the guidelines for biosimilars approval and found the list of biosimilars on the market. It revealed that every country is a different case with geographic specificity and that government takes adapted decision on this subject with the objectives to treat a more important part of the population than with biologic innovators.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01186057
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Submitted on : Monday, August 24, 2015 - 10:21:20 AM
Last modification on : Tuesday, May 11, 2021 - 11:36:18 AM
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  • HAL Id : dumas-01186057, version 1

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Alice Bousselet. L’impact des politiques et des réglementations sur les biosimilaires dans l’Union Européenne, aux États Unis, en Inde, au Brésil, en Chine et en Corée du Sud. Sciences pharmaceutiques. 2014. ⟨dumas-01186057⟩

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