Demonstration of Equivalence of Generic Glatiramer Acetate and Copaxone®

• Main Authors: Peter Lipsky (Author), Patrick T. Vallano (Author), Jeffrey Smith (Author), Walter Owens (Author), Daniel Snider (Author), Viswanath Bandaru (Author), Yunfu Sun (Author), Ross Wallingford (Author), Joseph Duncan (Author), Joshua Lewis (Author), Jason Southall (Author), Azeem Ansari (Author), Hong Li (Author)
• Format: Book
• Published: Frontiers Media S.A., 2021-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The objective of the current work was to demonstrate the equivalence of Mylan's glatiramer acetate (GA) to that of the reference product Copaxone® (COP) using the four criteria for active pharmaceutical ingredient sameness as established by the US Food and Drug Administration (FDA). The reactio...