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Master Thesis

Particularités des essais cliniques portant sur les biosimilaires

Abstract : Biologic products represent a major therapeutic advance and enable solutions to be found for rare or serious diseases for which no treatment exists. With the recent expiry of patents for the original biologic products, many copies of these medicines are appearing on the market. Due to their specific features and differences compared to traditional medicines, the standard "generic" approach is not applicable for the development of these copies called "biosimilars". Through the review of international recommendations and literature on the clinical trials already performed for biosimilars, this paper extracts a set of eight guidelines to assist a manufacturer in the establishment of a clinical development plan for a biosimilar.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01113833
Contributor : Jean-Hugues Morneau <>
Submitted on : Friday, February 6, 2015 - 1:42:48 PM
Last modification on : Tuesday, May 11, 2021 - 11:36:17 AM
Long-term archiving on: : Sunday, April 16, 2017 - 8:16:27 AM

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  • HAL Id : dumas-01113833, version 1

Citation

Maud Reynier. Particularités des essais cliniques portant sur les biosimilaires. Sciences pharmaceutiques. 2014. ⟨dumas-01113833⟩

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