Demonstration of Biological and Immunological Equivalence of a Generic Glatiramer Acetate

摘要

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 that demonstrated equivalence to Copaxone.