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Evolution of the EU Biosimilar Framework: Past and Future

The approval of biosimilars in the EU follows a comprehensive scientific assessment based on stringent regulatory standards. While the initial approach to biosimilars was understandably cautious and conservative in that uncharted territory to protect patients’ safety, the analytical and scientific p...

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Detalles Bibliográficos
Autores principales: Wolff-Holz, Elena, Tiitso, Klara, Vleminckx, Camille, Weise, Martina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875146/
https://www.ncbi.nlm.nih.gov/pubmed/31541400
http://dx.doi.org/10.1007/s40259-019-00377-y