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Marketing Authorisation of Generics, Biosimilars, and Hybrid Medicinal Products

Florence Taboulet, Aurélie Mahalatchimy

Content type:
Encyclopedia entries
Product:
The Oxford Encylopedia of EU Law [OEEUL]
Article last updated:
October 2021

From: Oxford Public International Law (http://opil.ouplaw.com). (c) Oxford University Press, 2023. All Rights Reserved.date: 03 October 2024

Subject(s):
Health
This work has been partially supported by ANR-funded I-BioLex project (ANR-20-CE26-0007-01) and by H2020-funded EuroGCT project (GA965241). 1 Generics, biosimilars, and hybrid medicinal products are similar to already authorized medicinal products. That is why their marketing authorization procedure (centralized authorization of medicines marketing or decentralized authorisation of medicines marketing) is simplified although they need a marketing authorization the same as any other medicines. The authorization of abbreviated applications for these medicines means...
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