Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?

BACKGROUND: There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval of more complex biosimilar substances such as monoclonal antibodies (mAbs). OBJECTIVE: The aim of this paper is to further analyse the role of quality/chemistry, man...

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Detalles Bibliográficos
Autores principales: Kirsch-Stefan, Nadine, Guillen, Elena, Ekman, Niklas, Barry, Sean, Knippel, Verena, Killalea, Sheila, Weise, Martina, Wolff-Holz, Elena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10581956/
https://www.ncbi.nlm.nih.gov/pubmed/37831324
http://dx.doi.org/10.1007/s40259-023-00631-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10581956/
https://www.ncbi.nlm.nih.gov/pubmed/37831324
http://dx.doi.org/10.1007/s40259-023-00631-4

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