Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines

Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges. Materials and Methods: The current valid guidelines...

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Detalles Bibliográficos
Autores principales: Rahalkar, Hasumati, Cetintas, Hacer Coskun, Salek, Sam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2018
Materias:
Pharmacology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192287/
https://www.ncbi.nlm.nih.gov/pubmed/30364154
http://dx.doi.org/10.3389/fphar.2018.01079

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192287/
https://www.ncbi.nlm.nih.gov/pubmed/30364154
http://dx.doi.org/10.3389/fphar.2018.01079

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