Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities

Slow uptake of biosimilars in some regions is often attributed to a lack of knowledge combined with concerns about safety and efficacy. To alleviate physician and patient apprehensions, regulatory reviews from four major regulatory authorities (RAs) (European Medicines Agency, US Food and Drug Admin...

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Detalles Bibliográficos
Autores principales: Ingram, Beverly, Lumsden, Rebecca S., Radosavljevic, Adriana, Kobryn, Christine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8067310/
https://www.ncbi.nlm.nih.gov/pubmed/33915725
http://dx.doi.org/10.3390/ph14040306

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8067310/
https://www.ncbi.nlm.nih.gov/pubmed/33915725
http://dx.doi.org/10.3390/ph14040306

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