Development of Glatopa® (Glatiramer Acetate)

The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis

Christine Bell, James Anderson, Tanmoy Ganguly, James Prescott, Ishan Capila, Jonathan C. Lansing, Richard Sachleben, Mani Iyer, Ian Fier, James Roach, Kristina Storey, Paul Miller, Steven Hall, Daniel Kantor, Benjamin M. Greenberg, Kavita Nair, Joseph Glajch

Research output: Contribution to journalReview article

6 Citations (Scopus)

Abstract

The multiple sclerosis (MS) treatment landscape in the United States has changed dramatically over the past decade. While many disease-modifying therapies (DMTs) have been approved by the US Food and Drug Administration (FDA) for the treatment of relapsing forms of MS, DMT costs continue to rise. The availability of generics and biosimilars in the MS-treatment landscape is unlikely to have a major impact on clinical benefit. However, their availability will provide alternative treatment options and potentially lower costs through competition, thus increasing the affordability of and access to these drugs. In April 2015, the first generic version of the complex drug glatiramer acetate (Glatopa® 20 mg/mL) injection was approved in the United States as a fully substitutable generic for all approved indications of the 20 mg/mL branded glatiramer acetate (Copaxone®) dosage form. Despite glatiramer acetate’s complex nature—being a chemically synthesized (ie, nonbiologic) mixture of peptides—the approval occurred without conducting any clinical trials. Rather, extensive structural and functional characterization was performed to demonstrate therapeutic equivalence to the innovator drug. The approval of Glatopa signifies an important milestone in the US MS-treatment landscape, with the hope that the introduction of generic DMTs and eventually biosimilar DMTs will lead to future improvements in the affordability and access of these much-needed treatments for MS.

Original languageEnglish (US)
Pages (from-to)481-488
Number of pages8
JournalJournal of Pharmacy Practice
Volume31
Issue number5
DOIs
StatePublished - Oct 1 2018

Fingerprint

United States Food and Drug Administration
Multiple Sclerosis
Biosimilar Pharmaceuticals
Therapeutics
Glatiramer Acetate
Pharmaceutical Preparations
Costs and Cost Analysis
Dosage Forms
Clinical Trials
Injections

Keywords

  • disease-modifying therapy
  • generic drugs
  • glatiramer acetate
  • multiple sclerosis

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Development of Glatopa® (Glatiramer Acetate) : The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis. / Bell, Christine; Anderson, James; Ganguly, Tanmoy; Prescott, James; Capila, Ishan; Lansing, Jonathan C.; Sachleben, Richard; Iyer, Mani; Fier, Ian; Roach, James; Storey, Kristina; Miller, Paul; Hall, Steven; Kantor, Daniel; Greenberg, Benjamin M.; Nair, Kavita; Glajch, Joseph.

In: Journal of Pharmacy Practice, Vol. 31, No. 5, 01.10.2018, p. 481-488.

Research output: Contribution to journalReview article

Bell, C, Anderson, J, Ganguly, T, Prescott, J, Capila, I, Lansing, JC, Sachleben, R, Iyer, M, Fier, I, Roach, J, Storey, K, Miller, P, Hall, S, Kantor, D, Greenberg, BM, Nair, K & Glajch, J 2018, 'Development of Glatopa® (Glatiramer Acetate): The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis', Journal of Pharmacy Practice, vol. 31, no. 5, pp. 481-488. https://doi.org/10.1177/0897190017725984
Bell, Christine ; Anderson, James ; Ganguly, Tanmoy ; Prescott, James ; Capila, Ishan ; Lansing, Jonathan C. ; Sachleben, Richard ; Iyer, Mani ; Fier, Ian ; Roach, James ; Storey, Kristina ; Miller, Paul ; Hall, Steven ; Kantor, Daniel ; Greenberg, Benjamin M. ; Nair, Kavita ; Glajch, Joseph. / Development of Glatopa® (Glatiramer Acetate) : The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis. In: Journal of Pharmacy Practice. 2018 ; Vol. 31, No. 5. pp. 481-488.
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abstract = "The multiple sclerosis (MS) treatment landscape in the United States has changed dramatically over the past decade. While many disease-modifying therapies (DMTs) have been approved by the US Food and Drug Administration (FDA) for the treatment of relapsing forms of MS, DMT costs continue to rise. The availability of generics and biosimilars in the MS-treatment landscape is unlikely to have a major impact on clinical benefit. However, their availability will provide alternative treatment options and potentially lower costs through competition, thus increasing the affordability of and access to these drugs. In April 2015, the first generic version of the complex drug glatiramer acetate (Glatopa{\circledR} 20 mg/mL) injection was approved in the United States as a fully substitutable generic for all approved indications of the 20 mg/mL branded glatiramer acetate (Copaxone{\circledR}) dosage form. Despite glatiramer acetate’s complex nature—being a chemically synthesized (ie, nonbiologic) mixture of peptides—the approval occurred without conducting any clinical trials. Rather, extensive structural and functional characterization was performed to demonstrate therapeutic equivalence to the innovator drug. The approval of Glatopa signifies an important milestone in the US MS-treatment landscape, with the hope that the introduction of generic DMTs and eventually biosimilar DMTs will lead to future improvements in the affordability and access of these much-needed treatments for MS.",
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