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- W2012942455 abstract "Issues concerning the approval of biosimilars are currently being addressed by the US Food and Drug Administration and the European Medicines Agency. There appears to be a consensus that immunogenicity impacts comparability studies and the interchangeability of biosimilars. In addition, preclinical immunogenicity assessment and mitigation, if validated in clinical studies, might impact patient safety and development costs, and also facilitate the development of ‘biobetters’ and other protein therapeutics. This review addresses recent advances in the field of biosimilars and focuses on predictive immunology, with an emphasis on preclinical immunogenicity assessments of protein therapeutics other than vaccines and their corresponding clinical outcomes." @default.
- W2012942455 created "2016-06-24" @default.
- W2012942455 creator A5090235626 @default.
- W2012942455 date "2011-04-01" @default.
- W2012942455 modified "2023-10-07" @default.
- W2012942455 title "Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters" @default.
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- W2012942455 doi "https://doi.org/10.1016/j.drudis.2011.01.011" @default.
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