Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars

Regulatory approval of biosimilars predominantly relies on biosimilarity assessments of quality attributes (QAs), particularly the potentially critical QAs (pCQAs) that may affect the clinical profile. However, a limited understanding exists concerning how EU regulators reflect the biosimilarity ass...

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Detalles Bibliográficos
Autores principales: Alsamil, Ali M., Giezen, Thijs J., Egberts, Toine C., Leufkens, Hubert G., Gardarsdottir, Helga
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996580/
https://www.ncbi.nlm.nih.gov/pubmed/33669108
http://dx.doi.org/10.3390/ph14030189

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996580/
https://www.ncbi.nlm.nih.gov/pubmed/33669108
http://dx.doi.org/10.3390/ph14030189

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