Regulatory challenges with biosimilars: an update from 20 countries

The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey...

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Detalles Bibliográficos
Autores principales: Kang, Hye‐Na, Thorpe, Robin, Knezevic, Ivana, Casas Levano, Mary, Chilufya, Mumbi Bernice, Chirachanakul, Parichard, Chua, Hui Ming, Dalili, Dina, Foo, Freddie, Gao, Kai, Habahbeh, Suna, Hamel, Hugo, Kim, Gi Hyun, Perez Rodriguez, Violeta, Putri, Desi Eka, Rodgers, Jacqueline, Savkina, Maria, Semeniuk, Oleh, Srivastava, Shraddha, Tavares Neto, João, Wadhwa, Meenu, Yamaguchi, Teruhide
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Original Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247359/
https://www.ncbi.nlm.nih.gov/pubmed/33222245
http://dx.doi.org/10.1111/nyas.14522

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