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Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices
The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy on the scientific basis for extrapolation of indications for biosimilars, which has be...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2016
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746210/ https://www.ncbi.nlm.nih.gov/pubmed/26758077 http://dx.doi.org/10.1007/s40259-015-0154-1 |