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Evolution of the EU Biosimilar Framework: Past and Future
The approval of biosimilars in the EU follows a comprehensive scientific assessment based on stringent regulatory standards. While the initial approach to biosimilars was understandably cautious and conservative in that uncharted territory to protect patients’ safety, the analytical and scientific p...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer International Publishing
2019
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875146/ https://www.ncbi.nlm.nih.gov/pubmed/31541400 http://dx.doi.org/10.1007/s40259-019-00377-y |