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Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?
A biosimilar is a biologic drug that is “highly similar to a reference (originator) product, with no clinically meaningful differences between the two products in safety, purity, and potency”. Regulatory approval of a biosimilar is based on analytical, structural, and functional comparisons with the...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2020
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7669758/ https://www.ncbi.nlm.nih.gov/pubmed/32990892 http://dx.doi.org/10.1007/s40259-020-00446-7 |