Demonstration of equivalence of a generic glatiramer acetate (Glatopa™)

James Anderson, Christine Bell*, John Bishop, Ishan Capila, Tanmoy Ganguly, Joseph Glajch, Mani Iyer, Ganesh Kaundinya, Jonathan Lansing, Joel Pradines, James Prescott, Bruce A. Cohen, Daniel Kantor, Richard Sachleben

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

31 Scopus citations

Abstract

Glatiramer acetate (GA) has been available under the brand name Copaxone® for nearly two decades. Recently, the US Food and Drug Administration (FDA) approved the first generic GA, Glatopa™, as fully substitutable for all indications for which Copaxone 20 mg is approved; Glatopa also represents the first FDA-approved "AP-rated," substitutable generic for treating patients with MS. Glatiramer acetate is a complex mixture of polypeptides and, consequently, its characterization presented challenges not generally encountered in drug development. Despite its complexity, and without requiring any clinical data, approval was accomplished through an Abbreviated New Drug Application in which equivalence to Copaxone was evaluated across four criteria: starting materials and basic chemistry; structural signatures for polymerization, depolymerization, and purification; physicochemical properties; and biological and immunological properties. This article describes the rigorous overall scientific approach used to successfully establish equivalence between Glatopa and Copaxone, and presents key representative data from several of the comprehensive sets of physicochemical (structural) and biological (functional) assays that were conducted.

Original languageEnglish (US)
Pages (from-to)24-34
Number of pages11
JournalJournal of the Neurological Sciences
Volume359
Issue number1-2
DOIs
StatePublished - Dec 15 2015

Keywords

  • Drugs
  • Generic
  • Generic equivalency
  • Glatiramer acetate
  • Multiple sclerosis

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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