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Regulatory evaluation of biosimilars throughout their product life-cycle

The World Health Assembly in 2014 adopted a resolution that recognized the importance of increasing access to biotherapeutic products, of improving their affordability and of ensuring their quality, safety and efficacy. Biosimilars are biotherapeutic products similar to already licensed reference pr...

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Detalles Bibliográficos
Autores principales: Kang, Hye-Na, Knezevic, Ivana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: World Health Organization 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5872015/
https://www.ncbi.nlm.nih.gov/pubmed/29695884
http://dx.doi.org/10.2471/BLT.17.206284