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Demonstration of Biological and Immunological Equivalence of a Generic Glatiramer Acetate
BACKGROUND: In April 2015, the US Food and Drug Administration approved the first generic glatiramer acetate, Glatopa® (M356), as fully substitutable for Copaxone® 20 mg/mL for relapsing forms of multiple sclerosis (MS). This approval was accomplished through an Abbreviated New Drug Applica-tion tha...
| Autores principales: | , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Bentham Science Publishers
2017
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5684786/ https://www.ncbi.nlm.nih.gov/pubmed/28240190 http://dx.doi.org/10.2174/1871527316666170223162747 |