Glatiramer acetate: long-term safety and efficacy in relapsing-remitting multiple sclerosis

References

• Scott LJ. Glatiramer acetate: a review of its use in patients with relapsing-remitting multiple sclerosis and in delaying the onset of clinically definite multiple sclerosis. CNS Drugs 2013;27:971-88
   PubMed Web of Science ®Google Scholar
• Lalive PH, Neuhaus O, Benkhoucha M, et al. Glatiramer acetate in the treatment of multiple sclerosis: emerging concepts regarding its mechanism of action. CNS Drugs 2011;25:401-14
   PubMed Web of Science ®Google Scholar
• Fricker J. The copolymer-1 story so far. Lancet 1998;351:1792
   PubMedGoogle Scholar
• Towfic F, Funt JM, Fowler KD, et al. Comparing the biological impact of glatiramer acetate with the biological impact of a generic. PLoS One 2014;9(1):e83757
   PubMed Web of Science ®Google Scholar
• Ramot Y, Rosenstock M, Klinger E, et al. Comparative long-term preclinical safety evaluation of two glatiramoid compounds (glatiramer acetate, Copaxone®, and TV-5010, protiramer) in rats and monkeys. Toxicol Pathol 2012;40(1):40-54
   PubMed Web of Science ®Google Scholar
• Bornstein MB, Miller A, Slagle S, et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med 1987;317:408-14
   PubMed Web of Science ®Google Scholar
• Scheindlin S. Copolymer 1: an off-beat drug development story. Mol Interv 2004;4:6-9
   PubMedGoogle Scholar
• Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. Neurology 1995;45:1268-76
   PubMed Web of Science ®Google Scholar
• Comi G, Filippi M, Wolinsky JS. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging–measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol 2001;49:290-7
   PubMed Web of Science ®Google Scholar
• Sormani MP, Filippi M, De Stefano N. MRI as an outcome in multiple sclerosis clinical trials. Neurology 2009;73(22):1932
   PubMedGoogle Scholar
• Filippi M, Rocca MA, Camesasca F, et al. Interferon beta-1b and glatiramer acetate effects on permanent black hole evolution. Neurology 2011;76:1222-8
   PubMedGoogle Scholar
• Comi G, Martinelli V, Rodegher M, et al. Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome. Mult Scler 2013;19:1074-83
   PubMed Web of Science ®Google Scholar
• Arnold DL, Narayanan S, Antel S. Neuroprotection with glatiramer acetate: evidence from the PreCISe trial. J Neurol 2013;260:1901-6
   PubMed Web of Science ®Google Scholar
• Comi G, Martinelli V, Rodegher M, et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet 2009;374:1503-11
   PubMed Web of Science ®Google Scholar
• O’Connor P, Filippi M, Arnason B, et al. 250 mcg or 500 mcg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol 2009;8:889-97
   PubMed Web of Science ®Google Scholar
• Johnson KP. Risks vs benefits of glatiramer acetate: a changing perspective as new therapies emerge for multiple sclerosis. Ther Clin Risk Manag 2010;6:153-72
   PubMed Web of Science ®Google Scholar
• Qizilbash N, Mendez I, Sanchez-de la Rosa R. Benefit-risk analysis of glatiramer acetate for relapsing-remitting and clinically isolated syndrome multiple sclerosis. Clin Ther 2012;34:159-76
   PubMedGoogle Scholar
• Johnson KP. Glatiramer acetate for treatment of relapsing-remitting multiple sclerosis. Expert Rev Neurother 2012;12:371-84
   PubMed Web of Science ®Google Scholar
• Copaxone^® (glatiramer acetate injection) [package insert]. Teva Neuroscience, Inc; Kansas City, MO: August 2012
   Google Scholar
• Aharoni R. The mechanism of action of glatiramer acetate in multiple sclerosis and beyond. Autoimmunity Rev 2013;12:543-53
   PubMed Web of Science ®Google Scholar
• Aharoni R. Immunomodulation neuroprotection and remyelination - The fundamental therapeutic effects of glatiramer acetate: A critical review. J Autoimmun 2014;54:81-92
   PubMed Web of Science ®Google Scholar
• Ireland SJ, Guzman AA, O’Brien DE, et al. The effect of glatiramer acetate therapy on functional properties of B cells from patients with relapsing-remitting multiple sclerosis. JAMA Neurol 2014;71(11):1421-8
   PubMed Web of Science ®Google Scholar
• Arnon R, Aharoni R. Neuroprotection and neurogeneration in MS and its animal model EAE effected by glatiramer acetate. J Neural Transm 2009;116:1443-9
   PubMed Web of Science ®Google Scholar
• Aharoni R, Arnon R. Linkage between immunomodulation, neuroprotection and neurogenesis. Drug News Perspect 2009;22:301-12
   PubMed Web of Science ®Google Scholar
• Aharoni R, Kayhan B, Eilam R, et al. Glatiramer acetate-specific T cells in the brain express T helper 2/3 cytokines and brain-derived neurotrophic factor in situ. Proc Natl Acad Sci USA 2003;100:14157-62
   PubMed Web of Science ®Google Scholar
• Aharoni R, Eilam R, Domev H, et al. The immunomodulator glatiramer acetate augments the expression of neurotrophic factors in brains of experimental autoimmune encephalomyelitis mice. Proc Natl Acad Sci USA 2005;102:19045-50
   PubMed Web of Science ®Google Scholar
• Skihar V, Silva C, Chojnacki A, et al. Promoting oligodendrogenesis and myelin repair using the multiple sclerosis medication glatiramer acetate. Proc Natl Acad Sci USA 2009;106:17992-7
   PubMed Web of Science ®Google Scholar
• Zhang Y, Jalili F, Ouamara N, et al. Glatiramer acetate-reactive T lymphocytes regulate oligodendrocyte progenitor cell number in vitro: role of IGF-2. J Neuroimmunol 2010;227:71-9
   PubMedGoogle Scholar
• Gilgun-Sherki Y, Panet H, Holdengreber V, et al. Axonal damage is reduced following glatiramer acetate treatment in C57/bl mice with chronic-induced experimental autoimmune encephalomyelitis. Neurosci Res 2003;47:201-7
   PubMed Web of Science ®Google Scholar
• Maier K, Kuhnert AV, Taheri N, et al. Effects of glatiramer acetate and interferon-beta on neurodegeneration in a model of multiple sclerosis: a comparative study. Am J Pathol 2006;169:1353-64
   PubMed Web of Science ®Google Scholar
• Aharoni R, Herschkovitz A, Eilam R, et al. Demyelination arrest and remyelination induced by glatiramer acetate treatment of experimental autoimmune encephalomyelitis. Proc Natl Acad Sci USA 2008;105:11358-63
   PubMed Web of Science ®Google Scholar
• Aharoni R, Vainshtein A, Stock A, et al. Distinct pathological patterns in relapsing-remitting and chronic models of experimental autoimmune encephalomyelitis and the neuroprotective effect of glatiramer acetate. J Autoimmun 2011;37:228-41
   PubMed Web of Science ®Google Scholar
• Kala M, Miravalle A, Vollmer T. Recent insights into the mechanism of action of glatiramer acetate. J Neuroimmunol 2011;235:9-17
   PubMed Web of Science ®Google Scholar
• Azoulay D, Vachapova V, Shihman B, et al. Lower brain-derived neurotrophic factor in serum of relapsing remitting MS: reversal by glatiramer acetate. J Neuroimmunol 2005;167:215-18
   PubMed Web of Science ®Google Scholar
• Frischer JM, Bramow S, Dal-Bianco A, et al. The relation between inflammation and neurodegeneration in multiple sclerosis brains. Brain 2009;132(Pt 5):1175-89
   PubMed Web of Science ®Google Scholar
• Lassmann H. Cortical lesions in multiple sclerosis: inflammation versus neurodegeneration. Brain 2012;135(Pt 10):2904-5
   PubMedGoogle Scholar
• Johnson KP, Brooks BR, Cohen JA, et al. Extended use of glatiramer acetate (Copaxone) is well tolerated and maintains its clinical effect on multiple sclerosis relapse rate and degree of disability. Neurology 1998;50:701-8
   PubMed Web of Science ®Google Scholar
• Johnson KP, Brooks BR, Ford CC, et al. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Mult Scler 2000;6:255-66
   PubMed Web of Science ®Google Scholar
• Johnson KP, Ford CC, Lisak RP, Wolinsky JS. Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data. Acta Neurol Scand 2005;111:42-7
   PubMed Web of Science ®Google Scholar
• Ford CC, Johnson KP, Lisak RP, et al. A prospective open-label study of glatiramer acetate: over a decade of continuous use in multiple sclerosis patients. Mult Scler 2006;12:309-20
   PubMed Web of Science ®Google Scholar
• Ford C, Goodman AD, Johnson K, et al. Continuous long-term immunomodulatory therapy in relapsing multiple sclerosis: results from the 15-year analysis of the US prospective open-label study of glatiramer acetate. Mult Scler 2010;16:342-50
   PubMed Web of Science ®Google Scholar
• Rovaris M, Comi G, Rocca MA, et al. Long-term follow-up of patients treated with glatiramer acetate: a multicentre, multinational extension of the European/Canadian double-blind, placebo-controlled, MRI-monitored trial. Mult Scler 2007;13:502-8
   PubMed Web of Science ®Google Scholar
• Ford C, Ladkani D. Twenty years of continuous treatment of multiple sclerosis with glatiramer acetate 20 mg daily: long-term clinical results of the US open-label extension study. Presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); 2-5 October 2013; Copenhagen, Denmark
   Google Scholar
• Confavreux C, Vukusic S. Natural history of multiple sclerosis: a unifying concept. Brain 2006;129(Pt 3):606-16
   PubMed Web of Science ®Google Scholar
• Copaxone® Study to follow patients from the first original study for safety and effectiveness. Available from: https://clinicaltrials.gov/ct2/show/NCT00203021 [Access 22 April 2015]
   Google Scholar
• Khan O, Bao F, Shah M, et al. MRI correlates of disability: neuroimaging substudy at 20 years in the ongoing US Glatiramer Acetate open-label extension study. Presented at the Annual Meeting of the American Academy of Neurology, April 26 - May 3 2014. Philadelphia, PA
   Google Scholar
• Haas J, Firzlaff M. Twenty-four-month comparison of immunomodulatory treatments: a retrospective open label study in 308 RRMS patients treated with beta interferons or glatiramer acetate (Copaxone®). Eur J Neurol 2005;12:425-31
   PubMed Web of Science ®Google Scholar
• Oleen-Burkey M, Cyhaniuk A, Swallow E. Retrospective US database analysis of persistence with glatiramer acetate vs available disease-modifying therapies for multiple sclerosis: 2001-2010. BMC Neurol 2014;14:11
   PubMedGoogle Scholar
• Menzin J, Caon C, Nichols C, et al. Narrative review of the literature on adherence to disease-modifying therapies among patients with multiple sclerosis. J Manag Care Pharm 2013;19:S24-40
   PubMed Web of Science ®Google Scholar
• Ziemssen T, Bajenaru O, Carrá A, et al. A 2-year observational study of patients with relapsing-remitting multiple sclerosis switching to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial. J Neurol 2014;261(11):12101-11
   Google Scholar
• Smith B, Carson S, Fu R, et al. Drug class review: disease-modifying drugs for multiple sclerosis: final update 1 report [Internet]. Portland (OR): Oregon Health & Science University. 2010. Available from: www.ncbi.nlm.nih.gov/books/NBK50570/ [Accessed 6 March `2014]
   Google Scholar
• Zwibel HL. Glatiramer acetate in treatment-naive and prior interferon-β-1b-treated multiple sclerosis patients. Acta Neurol Scand 2006;113:378-86
   PubMedGoogle Scholar
• Khan O, Rieckmann P, Boyko A, et al. Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis. Ann Neurol 2013;73:705-13
   PubMed Web of Science ®Google Scholar
• Mikol DD, Barkhof F, Chang P, et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol 2008;7:903-14
   PubMed Web of Science ®Google Scholar
• Cadavid D, Wolansky LJ, Shurnick J, et al. Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study. Neurology 2009;72:1976-83
   PubMed Web of Science ®Google Scholar
• Castelli-Haley J, Oleen-Burkey MKA. Glatiramer acetate versus interferon beta-1a for subcutaneous administration: comparison of outcomes among multiple sclerosis patients. Adv Ther 2008;25:658-73
   PubMed Web of Science ®Google Scholar
• Lublin FD, Cofield SS, Cutter GR, et al. Randomized study combining interferon and glatiramer acetate in multiple sclerosis. Ann Neurol 2013;73:327-40
   PubMed Web of Science ®Google Scholar
• Darbà J, Kaskens L, Sánchez-de la Rosa R. Cost-effectiveness of glatiramer acetate and interferon beta-1a for relapsing-remitting multiple sclerosis, based on the CombiRx study. J Med Econ 2014;17:215-22
   PubMedGoogle Scholar
• Castelli-Haley J, Oleen-Burkey MA, Lage MJ, et al. Glatiramer acetate and interferon beta-1b: a study of outcomes among patients with multiple sclerosis. Adv Ther 2009;26:552-62
   PubMed Web of Science ®Google Scholar
• Boster A, Bartoszek MP, O’Connell C, et al. Efficacy, safety, and cost-effectiveness of glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis. Ther Adv Neurol Disord 2011;4:319-32
   PubMedGoogle Scholar
• Fox RJ, Miller DH, Phillips T, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97
   PubMed Web of Science ®Google Scholar
• Avonex^® (interferon beta-1a) [package insert]. Biogen Idec Inc., Cambridge, MA; March 2013
   Google Scholar
• Betaseron^® (interferon beta-1b) [package insert]. Bayer HealthCare Pharmaceuticals Inc, Whippany, NJ; September 2013
   Google Scholar
• Tysabri^® (natalizumab) [package insert]. Biogen Idec Inc., Cambridge, MA; December 2013
   Google Scholar
• Gilenya^® (fingolimod) [package insert]. Novartis Pharmaceuticals Corporation, East Hanover, NJ; May 2012
   Google Scholar
• Novantrone^® (mitoxantrone) [package insert]. EMD Serono, Inc., Rockland, MA; August 2008
   Google Scholar
• Aubagio^® (teriflunomide) [package insert]. Genzyme Corporation, Cambridge, MA; September 2012
   Google Scholar
• Hellwig K, Haghikia A, Rockhoff M, Gold R. Multiple sclerosis and pregnancy: experience from a nationwide database in Germany. Ther Adv Neurol Disord 2012;5:247-53
   PubMed Web of Science ®Google Scholar
• Fragoso YD, Finkelsztejn A, Kaimen-Maciel DR, et al. Long-term use of glatiramer acetate by 11 pregnant women with multiple sclerosis: a retrospective, multicentre case series. CNS Drugs 2010;24:969-76
   PubMed Web of Science ®Google Scholar
• Weber-Schoendorfer C, Schaefer C. Multiple sclerosis, immunomodulators, and pregnancy outcome: a prospective observational study. Mult Scler 2009;15:1037-42
   PubMed Web of Science ®Google Scholar
• Salminen HJ, Leggett H, Boggild M. Glatiramer acetate exposure in pregnancy: preliminary safety and birth outcomes. J Neurol 2010;257:2020-3
   PubMed Web of Science ®Google Scholar
• Giannini M, Portaccio E, Ghezzi A, et al. Pregnancy and fetal outcomes after glatiramer acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study. BMC Neurol 2012;12:124
   PubMed Web of Science ®Google Scholar
• Fragoso YD, Adoni T, Alves-Leon SV, et al. Long-term effects of exposure to disease-modifying drugs in the offspring of mothers with multiple sclerosis: a retrospective chart review. CNS Drugs 2013;27(11):955-61
   PubMed Web of Science ®Google Scholar
• Fragoso YD, Boggild M, Macias-Islas MA, et al. The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis. Clin Neurol Neurosurg 2013;115(2):154-9
   PubMed Web of Science ®Google Scholar
• Lu E, Wang BW, Guimond C, et al. Disease-modifying drugs for multiple sclerosis in pregnancy: a systematic review. Neurology 2012;79:1130-5
   PubMed Web of Science ®Google Scholar
• Lu E, Zhu F, Zhao Y, et al. Birth outcomes in newborns fathered by men with multiple sclerosis exposed to disease-modifying drugs. CNS Drugs 2014;28:475-82
   PubMedGoogle Scholar
• Confavreux C, Hutchinson M, Hours MM, et al. Pregnancy in Multiple Sclerosis Group. Rate of pregnancy-related relapse in multiple sclerosis. N Engl J Med 1998;339:285-91
   PubMed Web of Science ®Google Scholar
• Houtchens MK, Kolb CM. Multiple sclerosis and pregnancy: therapeutic considerations. J Neurol 2013;260:1202-14
   PubMed Web of Science ®Google Scholar
• Chitnis T. Disease-modifying therapy of pediatric multiple sclerosis. Neurotherapeutics 2013;10:89-96
   PubMed Web of Science ®Google Scholar
• National Multiple Sclerosis Society. Pediatric (Child) MS. Available from: www.nationalmssociety.org/about-multiple-sclerosis/pediatric-ms/index.aspx [Accessed 22 Jan 2014]
   Google Scholar
• Krupp L. Safety and tolerability of Copaxone in paediatric patients with relapsing-remitting multiple sclerosis. Presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 28 – October 1 2005; Thessaloniki, Greece; Poster 332
   Google Scholar
• Ghezzi A, Amato MP, Capobianco M, et al. Disease-modifying drugs in childhood-juvenile multiple sclerosis: results of an Italian co-operative study. Mult Scler 2005;11:420-4
   PubMed Web of Science ®Google Scholar
• Kornek B, Bernert G, Balassy C, et al. Glatiramer acetate treatment in patients with childhood and juvenile onset multiple sclerosis. Neuropediatrics 2003;34:120-6
   PubMed Web of Science ®Google Scholar
• Yeh EA, Waubant E, Krupp LB, et al. Multiple sclerosis therapies in pediatric patients with refractory multiple sclerosis. Arch Neurol 2011;68:437-44
   PubMedGoogle Scholar
• Mahurkar S, Suppiah V, O’Doherty C. Pharmacogenomics of interferon beta and glatiramer acetate response: a review of the literature. Autoimmun Rev 2014;13:178-86
   PubMed Web of Science ®Google Scholar
• Kulakova O, Tsareva E, Lvovs D, et al. Comparative pharmacogenetics of multiple sclerosis: IFN-β versus glatiramer acetate. Pharmacogenetics 2014;15:679-85
   Google Scholar
• Fusco C, Andreone V, Coppola G, et al. HLA-DRB1*1501 and response to copolymer-1 therapy in relapsing-remitting multiple sclerosis. Neurology 2001;57:1976-9
   PubMed Web of Science ®Google Scholar
• Gross R, Healy BC, Cepok S, et al. Population structure and HLA DRB1*1501 in the response of subjects with multiple sclerosis to first-line treatments. J Neuroimmunol 2011;233:168-74
   PubMed Web of Science ®Google Scholar
• Dhib-Jalbut S, Valenzuela RM, Ito K, et al. HLA DR and DQ alleles and haplotypes associated with clinical response to glatiramer acetate in multiple sclerosis. Mult Scler Relat Disord 2013;4:340-8
   Google Scholar
• Grossman I, Avidan N, Singer C, et al. Pharmacogenetics of glatiramer acetate therapy for multiple sclerosis reveals drug-response markers. Pharmacogenet Genomics 2007;17:657-66
   PubMed Web of Science ®Google Scholar
• Comi G, Cohen JA, Arnold DL, et al. Phase III dose-comparison study of glatiramer acetate for multiple sclerosis. Ann Neurol 2011;69:75-82
   PubMedGoogle Scholar
• Cohen JA, Rovaris M, Goodman AD, et al. Randomized, double-blind, dose-comparison study of glatiramer acetate in relapsing-remitting MS. Neurology 2007;68:939-44
   PubMed Web of Science ®Google Scholar
• Khan O, Caon C, Zak I, et al. Randomized, prospective, rater-blinded, four-year, pilot study to compare the effect of daily versus every-other-day glatiramer acetate 20 mg subcutaneous injections in relapsing-remitting multiple sclerosis. Mult Scler 2008;14(suppl 1):S296
   Google Scholar
• Zivadinov R, Dwyer M, Barkay H, et al. Effect of glatiramer acetate three-times weekly on the evolution of new, active multiple sclerosis lesions into T1-hypointense "black holes": a post hoc magnetic resonance imaging analysis. J Neurol 2015;262:648-53
   PubMed Web of Science ®Google Scholar
• Khan O, Rieckmann P, Boyko A, et al. 24-Month efficacy and safety of glatiramer acetate 40mg/1mL 3-times weekly: open-label extension study of the GALA trial in subjects with relapsing-remitting multiple sclerosis. Presented at the Annual Meeting of the American Academy of Neurology, April 26 - May 3 2014; Philadelphia PA
   Google Scholar
• Wolinsky JS, Borresen E, Dietrich DW, et al. GLACIER: An open-label, randomized, multicenter study to assess safety and tolerability of glatiramer acetate 40 mg/1ml 3-times weekly versus 20mg/ml daily in patients with relapsing-remitting multiple sclerosis. Presented at the Annual Meeting of the American Academy of Neurology, April 26 - May 3 2014; Philadelphia PA
   Google Scholar
• Momenta Pharmaceuticals Announces Filing of Abbreviated New Drug Application With a Paragraph IV Certification for Generic Version of Copaxone. July 11 2008. Available from: http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=320978 [Access date: 20 March 2015]
   Google Scholar
• Synthon VB. Synthon filed glatiramer acetate dossier in the US. Available from: http://www.synthon.com/Corporate/News/PressReleases/Synthon-filed-glatiramer-acetate-dossier-in-the-US?sc_lang=en Last update: December 13 2011. [Access date 21 March 2015]
   Google Scholar
• Varkony H, Weinstein V, Klinger E, et al. The glatiramoid class of immunomodulator drugs. Expert Opin Pharmacother 2009;10:657-68
   PubMed Web of Science ®Google Scholar
• Schellekens H, Stegemann S, Weinstein V, et al. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider. AAPSJ 2014;16:15-21
   PubMed Web of Science ®Google Scholar
• Nicholas JM. Complex drugs and biologics: Scientific and regulatory challenges for follow-on products. Drug Information J 2012;46:197-206
   Google Scholar
• Nicholas JM. Clinical development, immunogenicity, and interchangeability of follow-on complex drugs. Generics and Biosimilars Initiative Journal 2014;3:71-8
   Google Scholar
• Bakshi S, Chalifa-Caspi V, Plaschkes I, et al. Gene expression analysis reveals functional pathways of glatiramer acetate activation. Expert Opin Ther Targets 2013;17:351-62
   PubMed Web of Science ®Google Scholar
• Towfic F, Funt JM, Fowler KD, et al. Comparing the biological impact of glatiramer acetate with the biological impact of a generic. PLoS One 2014;9:e83757
   PubMed Web of Science ®Google Scholar
• Teva Pharmaceutical Industries Ltd. Citizen Petition Requesting That FDA Refrain From Approving Any Abbreviated New Drug Application Referencing Copaxone® (glatiramer acetate injection) Until Certain Conditions Are Met. Available from: http://www.regulations.gov/#!documentDetail;D=FDA-2014-P-0933-0001 July 2 2014. [Access date 21 March 2015]
   Google Scholar
• Cohen JA, Belova A, Selmaj K, et al. Generic glatiramer acetate is equivalent to Copaxone on efficacy and safety: results of the randomized double-blind GATE trial in multiple sclerosis (Abstract FC1.2). Presented at the 2014 annual joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis and the Americas Committee for Treatment and Research in Multiple Sclerosis. September 10-13, 2014; Boston, MA. Available from: www.professionalabstracts.com/msboston2014/planner/index.php?go=abstract&action=abstract_show&absno=687& Last update: December 9 2014. [Access date 21 March 2015]
   Google Scholar
• O’Connor P, Goodman A, Kappos L, et al. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology 2014;83:78-86
   PubMed Web of Science ®Google Scholar
• Cohen JA, Barkhof F, Comi G, et al. Fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362:402-15
   PubMed Web of Science ®Google Scholar