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

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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® 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.

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          Most cited references15

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          Clinically isolated syndromes suggestive of multiple sclerosis, part I: natural history, pathogenesis, diagnosis, and prognosis.

          In 85% of young adults with multiple sclerosis (MS), onset is a subacute clinically isolated syndrome (CIS) of the optic nerves, brainstem, or spinal cord. Methods of assessing the prognosis for patients who present with a CIS have been sought, because only 30-70% of patients with a CIS develop MS. When clinically silent brain lesions are seen on MRI, the likelihood of developing MS is high. MS can be diagnosed within 3 months of CIS presentation with certain MRI and CSF criteria. Disability from MS is less likely in patients with a CIS of optic neuritis or sensory symptoms only, few or no MRI lesions, a long period to the first relapse, and no disability after the first 5 years. Development of more reliable prognostic markers will enable new treatments to be targeted for those who are most likely to benefit. We encourage continued clinical and laboratory assessment of patients with a CIS.
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            Disease-modifying treatments for multiple sclerosis – a review of approved medications

            Background and purpose There is still no curative treatment for multiple sclerosis (MS), but during the last 20 years eight different disease-modifying compounds have been approved for relapsing−remitting MS (RRMS). Methods A literature search was conducted on published randomized controlled phase III trials indexed in PubMed on the approved medications until 21 May 2015. Results In this review the mode of action, documented treatment effects and side effects of the approved MS therapies are briefly discussed. Conclusions Based on current knowledge of risk−benefit of the approved MS medications, including factors influencing adherence, it is suggested that oral treatment with dimethyl fumarate or teriflunomide should be preferred as a starting therapy amongst the first-line preparations for de novo RRMS. In the case of breakthrough disease on first-line therapy, or rapidly evolving severe RRMS, second-line therapy with natalizumab, fingolimod or alemtuzumab should be chosen based on careful risk−benefit stratification.
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              Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines.

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                Author and article information

                Journal
                J Pharm Pract
                J Pharm Pract
                JPP
                spjpp
                Journal of Pharmacy Practice
                SAGE Publications (Sage CA: Los Angeles, CA )
                0897-1900
                1531-1937
                29 August 2017
                October 2018
                : 31
                : 5
                : 481-488
                Affiliations
                [1 ]Analytical Development, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [2 ]Pharmaceutical Sciences, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [3 ]Research and Development, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [4 ]Analytical Chemistry, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [5 ]Research, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [6 ]Complex Generics Manufacturing, Technical Operations, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [7 ]Chemical Development and Manufacturing, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [8 ]Program and Project Management, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [9 ]Clinical Development and Regulatory Affairs, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [10 ]Regulatory Affairs, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [11 ]Medical Affairs and Communications, Momenta Pharmaceuticals, Inc, Cambridge, MA, USA
                [12 ]Medical Affairs, Sandoz, Inc, a Novartis Division, Princeton, NJ, USA
                [13 ]Division of Neurology, Florida Atlantic University, Boca Raton, FL, USA
                [14 ]Neurology and Neurotherapeutics, Pediatrics, UT Southwestern Medical Center, Dallas, TX, USA
                [15 ]Department of Clinical Pharmacy, University of Colorado School of Pharmacy, Aurora, CO, USA
                Author notes
                [*]Tanmoy Ganguly, Momenta Pharmaceuticals, Inc, 675 West Kendall Street, Cambridge, MA 02142, USA. Email: tganguly@ 123456momentapharma.com
                Article
                10.1177_0897190017725984
                10.1177/0897190017725984
                6144347
                28847230
                0d097116-ade6-4568-a1a1-1a365a1a2a99
                © The Author(s) 2017

                This article is distributed under the terms of the Creative Commons Attribution 4.0 License ( http://www.creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

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                Review Articles

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

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