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

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 o...

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Bibliographic Details
Main Authors: Hasumati Rahalkar, Hacer Coskun Cetintas, Sam Salek
Format: Article
Language:English
Published: Frontiers Media S.A. 2018-09-01
Series:Frontiers in Pharmacology
Subjects:
monoclonal antibody
biosimilar
regulatory
comparability
quality
manufacturing
Online Access:https://www.frontiersin.org/article/10.3389/fphar.2018.01079/full

Internet

https://www.frontiersin.org/article/10.3389/fphar.2018.01079/full

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