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...

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Библиографические подробности
Опубликовано в: :CNS Neurol Disord Drug Targets
Главные авторы: D’Alessandro, Josephine, Garofalo, Kevin, Zhao, Ganlin, Honan, Christopher, Duffner, Jay, Capila, Ishan, Fier, Ian, Kaundinya, Ganesh, Kantor, Daniel, Ganguly, Tanmoy
Формат: Artigo
Язык:Inglês
Опубликовано: Bentham Science Publishers 2017
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Article
Online-ссылка:https://ncbi.nlm.nih.gov/pmc/articles/PMC5684786/
https://ncbi.nlm.nih.gov/pubmed/28240190
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2174/1871527316666170223162747
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