Development of Glatopa® (Glatiramer Acetate): The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis

• Published in: Journal of Pharmacy Practice Vol. 31; no. 5; pp. 481 - 488
• Main Authors: 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
• Format: Book Review Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01-10-2018
• Subjects: Adjuvants, Immunologic - chemical synthesis; Adjuvants, Immunologic - therapeutic use; Biosimilar Pharmaceuticals - chemical synthesis; Biosimilar Pharmaceuticals - therapeutic use; Drug Approval - legislation & jurisprudence; Drug Approval - methods; Drug Development - legislation & jurisprudence; Drug Development - methods; Drugs, Generic - therapeutic use; Glatiramer Acetate - chemical synthesis; Glatiramer Acetate - therapeutic use; Humans; Immunosuppressive Agents - chemical synthesis; Immunosuppressive Agents - therapeutic use; Multiple Sclerosis, Relapsing-Remitting - drug therapy; Multiple Sclerosis, Relapsing-Remitting - immunology; Peptides - chemical synthesis; Peptides - therapeutic use; Review; United States; United States; generic drugs; glatiramer acetate; multiple sclerosis; disease-modifying therapy
• ISSN: 0897-1900; 1531-1937
• DOI: 10.1177/0897190017725984

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.