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Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars
After 18 years and the administration of billions of doses, there is little doubt about biosimilars’ safety and efficacy. Yet, only 14 molecules in the EU and 9 in the US are available as biosimilars, among the 200+ targets, due mainly to the high development cost attributed to clinical efficacy tes...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Dove
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9420434/ https://www.ncbi.nlm.nih.gov/pubmed/36043044 http://dx.doi.org/10.2147/DDDT.S378813 |