The ‘totality-of-the-evidence’ approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product

The ‘totality-of-the-evidence’ biosimilarity concept requires that sufficient structural, functional, nonclinical, and clinical data are acquired in a stepwise manner, to demonstrate that no clinically meaningful differences in quality, safety, or efficacy are observed compared with the reference pr...

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Bibliografiske detaljer
Udgivet i:Therap Adv Gastroenterol
Main Authors: McClellan, Joseph E., Conlon, Hugh D., Bolt, Michael W., Kalfayan, Vatche, Palaparthy, Rameshraja, Rehman, Muhammad I., Kirchhoff, Carol F.
Format: Artigo
Sprog:Inglês
Udgivet: SAGE Publications 2019
Fag:
Review
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6566480/
https://ncbi.nlm.nih.gov/pubmed/31223341
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1756284819852535
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