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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer International Publishing
2019
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875156/ https://www.ncbi.nlm.nih.gov/pubmed/31440986 http://dx.doi.org/10.1007/s40259-019-00373-2 |