Development of Glatopa® (Glatiramer Acetate): The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis
| Autor: | Richard Sachleben, James Roach, Tanmoy Ganguly, Benjamin Greenberg, Jonathan C. Lansing, Daniel Kantor, Ian Fier, James H. Prescott, Hall Steven E, Christine Bell, Paul J. Miller, Kavita V. Nair, Kristina Storey, Ishan Capila, Joseph Glajch, James M. Anderson, Mani Iyer |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Drug medicine.medical_specialty Multiple Sclerosis media_common.quotation_subject Disease Relapsing-Remitting Generic Food and drug administration 03 medical and health sciences 0302 clinical medicine Multiple Sclerosis Relapsing-Remitting Adjuvants Immunologic Drug Development Innovator Immunologic medicine Drugs Generic Humans Pharmacology (medical) Adjuvants Pharmacology & Pharmacy Glatiramer acetate generic drugs Intensive care medicine Drug Approval Biosimilar Pharmaceuticals media_common business.industry Multiple sclerosis Drugs Biosimilar Glatiramer Acetate Pharmacology and Pharmaceutical Sciences medicine.disease United States disease-modifying therapy Clinical trial 030104 developmental biology Public Health and Health Services business Peptides 030217 neurology & neurosurgery Immunosuppressive Agents medicine.drug |
| Zdroj: | Journal of pharmacy practice, vol 31, iss 5 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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