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Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

Biosimilar filgrastim (Sandoz) was approved in Europe in 2009 and, in 2015, was the first biosimilar approved in the USA. These authorizations were based on the “totality of evidence” concept, an approach that considers data from structural and functional characterization and comparability analysis...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Veröffentlicht in:BioDrugs
Hauptverfasser: Gascon, Pere, Krendyukov, Andriy, Mathieson, Nicola, Natek, Maja, Aapro, Matti
Format: Artigo
Sprache:Inglês
Veröffentlicht: Springer International Publishing 2019
Schlagworte:
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6875156/
https://ncbi.nlm.nih.gov/pubmed/31440986
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-019-00373-2
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