title: Demonstration of equivalence of a generic glatiramer acetate (Glatopa™).
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 20mg 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.
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: janderson@momentapharma.com.
authors.forename: James
authors.initials: J
authors.lastname: Anderson
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: cbell@momentapharma.com.
authors.forename: Christine
authors.initials: C
authors.lastname: Bell
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: jbishop@momentapharma.com.
authors.forename: John
authors.initials: J
authors.lastname: Bishop
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: icapila@momentapharma.com.
authors.forename: Ishan
authors.initials: I
authors.lastname: Capila
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: tganguly@momentapharma.com.
authors.forename: Tanmoy
authors.initials: T
authors.lastname: Ganguly
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: jglajch@momentapharma.com.
authors.forename: Joseph
authors.initials: J
authors.lastname: Glajch
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: miyer@momentapharma.com.
authors.forename: Mani
authors.initials: M
authors.lastname: Iyer
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: ganesh@momentapharma.com.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Kaundinya
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: jlansing@momentapharma.com.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Lansing
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: jpradines@momentapharma.com.
authors.forename: Joel
authors.initials: J
authors.lastname: Pradines
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: jprescott@momentapharma.com.
authors.forename: James
authors.initials: J
authors.lastname: Prescott
authors.affiliation: Northwestern University Feinberg School of Medicine, 303 East Chicago Avenue, Chicago, IL 60611, United States. Electronic address: bac106@northwestern.edu.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Cohen
authors.affiliation: Kantor Neurology, 4851 West Hillsboro Blvd, Suite A-1, Coconut Creek, FL 33973, United States. Electronic address: dkantor.md@gmail.com.
authors.forename: Daniel
authors.initials: D
authors.lastname: Kantor
authors.affiliation: Momenta Pharmaceuticals, Inc., 675 West Kendall Street, Cambridge, MA 02142, United States. Electronic address: rsachleben@momentapharma.com.
authors.forename: Richard
authors.initials: R
authors.lastname: Sachleben
mesh_terms: D000068717:Glatiramer Acetate / Q000737:chemistry* / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000737:chemistry* / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy*; D013810:Therapeutic Equivalency
chemical_list: D007166:Immunosuppressive Agents; D000068717:Glatiramer Acetate
keywords: Drugs; Generic; Generic equivalency; Glatiramer acetate; Multiple sclerosis