Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union

The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing...

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Bibliografiske detaljer
Udgivet i:MAbs
Main Authors: van Aerts, Leon AGJM, De Smet, Karen, Reichmann, Gabriele, van der Laan, Jan Willem, Schneider, Christian K
Format: Artigo
Sprog:Inglês
Udgivet: Taylor & Francis 2014
Fag:
Perspective
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4622966/
https://ncbi.nlm.nih.gov/pubmed/25517301
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4161/mabs.29848
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