Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience

The World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2009. In 2019, the ECBS considered that a more tailored and potentially reduced clinical da...

Descripción completa

Detalles Bibliográficos
Autores principales: Kurki, Pekka, Kang, Hye-Na, Ekman, Niklas, Knezevic, Ivana, Weise, Martina, Wolff-Holz, Elena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Review Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9148871/
https://www.ncbi.nlm.nih.gov/pubmed/35596890
http://dx.doi.org/10.1007/s40259-022-00533-x

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9148871/
https://www.ncbi.nlm.nih.gov/pubmed/35596890
http://dx.doi.org/10.1007/s40259-022-00533-x

Ejemplares similares