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No two classes of biosimilars: Urgent advice to the US Congress and the FDA
WHAT IS KNOWN AND OBJECTIVE: The United States is the only country with legislation to approve two classes of biosimilars. One has “no clinically meaningful difference” from the reference product, and when it is tested for switching and alternating, it can receive an interchangeable status. The obje...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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John Wiley and Sons Inc.
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9796791/ https://www.ncbi.nlm.nih.gov/pubmed/35869625 http://dx.doi.org/10.1111/jcpt.13743 |