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Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars

BACKGROUND: Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, th...

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Foilsithe in:BioDrugs
Main Authors: Ebbers, Hans C., Fehrmann, Bjørn, Ottosen, Mette, Hvorslev, Niels, Høier, Pia, Hwang, Jae-Woong, Chung, Jinhan, Lim, Hyoung Taek, Lee, Shinjung, Hong, Juyoung, Rezk, Mourad Farouk
Formáid: Artigo
Teanga:Inglês
Foilsithe: Springer International Publishing 2020
Ábhair:
Rochtain Ar Líne:https://ncbi.nlm.nih.gov/pmc/articles/PMC7113226/
https://ncbi.nlm.nih.gov/pubmed/31925703
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-019-00402-0
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