References
- Lalive PH, Neuhaus O, Benkhoucha M. Glatiramer acetate in the treatment of multiple sclerosis: emerging concepts regarding its mechanism of action. CNS Drugs. 2011;25:401–414.
- Weinstein V, Nicholas JM, Schwartz R, et al. Glatiramoids. In: Crommelin DJA, De Vlieger JSB, eds. Non-biological complex drugs. NY: AAPS/Springer Advances in Pharmaceutical Sciences series; 2015. p. 107–148.
- Lygature.org (Internet) utrecht, The Netherlands. [ cited 2017 July 18]. Available from: www.lygature.org/non-biological-complex-drugs-working-group.
- Crommelin DJA, Shah VP, Klebovich I, et al. The similarity question for biologicals and non-biological complex drugs. Eur J Pharm Sci. 2015;76:10–17.
- Tevapharm.org. (Internet) Jerusalem, Israel. [ cited 2014]. Available from: http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1995004. Accessed 19 December 2017.
- Khan O, Rieckmann P, Boyko A, et al. Three times weekly glatiramer acetate in relapsing–remitting multiple sclerosis. Ann Neurol. 2013;73:705–713.
- Patrick M How could generic competition affect Copaxone’s revenues in 2016? 2016. http://marketrealist.com/2016/03/generic-competition-may-affect-copaxones-revenues-2016/. Accessed 19 December 2017
- Synthon. Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe. 2016. http://www.synthon.com/en/Corporate/News/PressReleases/Synthon-obtains-approval-for-glatiramer-acetate-20-mg-mL-in-Europe.aspx. Accessed 19 December 2017.
- Hasson T, Kolitz S, Towfic F, et al. Functional effects of the antigen glatiramer acetate are complex and tightly associated with its composition. J Neuroimmunol. 2016;290:84–95.
- GABI online. Follow-on versions of glatiramer acetate in Russia and Europe. 2017. http://www.gabionline.net/Non-Biological-Complex-Drugs/News/Follow-on-versions-of-glatiramer-acetate-in-Russia-and-Europe.Accessed 19 December 2017.
- Johnson KP. Glatiramer acetate for treatment of relapsing-remitting multiple sclerosis. Expert Rev Neurother. 2012;12:371–384.
- Cohen J, Belova A, Selmaj K, et al. Equivalence of generic glatiramer acetate in multiple sclerosis. a randomized clinical trial. JAMA Neurol. 2015;72:1433–1441.
- Selmaj K, Barkhof F, Belova AN, et al. Switching from branded to generic Glatiramer acetate: 15-month GATE trial extension results. Multiple Sclerosis J. 2017.
- CBG. Public assessment report scientific discussion glatirameracetaat Mylan 20 mg/ml, solution for injection, pre-filled syringe (glatiramer acetate). NL/H/3213/001/DC. 2016. https://db.cbg-meb.nl/Pars/h115993.pdf
- Anderson J, Bell C, Bishop J, et al. Demonstration of equivalence of a generic glatiramer acetate (Glatopa™). J Neurol Sci. 2015;359:24–34.
- Chen SL, Wu SL, Huang LJ, et al. A global comparability approach for biosimilar monoclonal antibodies using LC–tandem MS based proteomics. J Pharm Biomed Anal. 2013;80:126–135.
- TEVA. Product-specific bioequivalence recommendations; draft and revised draft guidances for industry; comments of teva pharmaceuticals industries ltd. To the draft bioequivalence guidance for glatiramer acetate injection. 2016. Docket No. FDA-2007-D-0369.
- Campos-García VR, López-Morales CA, Benites-Zaragoza E, et al. Design of a strong cation exchange methodology for the evaluation of charge heterogeneity in glatiramer acetate. J Pharm Biomedl Anal. 2017;132:133–140.
- Konfino E, Sela M, Teitelbaum D, et al. Copolymer-1 improvements in compositions of copolymers. 1994. https://www.google.com/patents/US7199098. Accessed 19 December 2017.
- FDA. FDA Substantive response to copaxone petition, docket no. FDA-2015-P-1050-0012 [ cited April 16, 2015] (“Copaxone Petition Response”).
- TEVA. TEVA Citizen Petition requesting that FDA consider new scientific information and refrain from approving any abbreviated new drug application referencing Copaxone® (glatiramer acetate injection) until certain conditions are met. 2015; Docket No. FDA-2015-P-1050.
- Shriver Z, Venkataraman G, Lansing J, et al. Methods of evaluating diethylamide in glatiramer acetate. 2006. https://www.google.com/patents/US8470603. Accessed 19 December 2017.
- Zhu X, Shriver Z, Jiang Y, et al. Analysis of amino acid copolymer compositions. 2008. https://www.google.com/patents/US7884187. Accessed 19 December 2017.
- Glajch J, Li Y, Analysis of glatiramer acetate. 2012. https://www.google.com/patents/US20140045740. Accessed 19 December 2017.
- Rogstad S, Pang E, Sommers C, et al. Modern analytics for synthetically derived complex drug substances: NMR, AFFF–MALS, and MS tests for Glatiramer acetate. Anal Bioanal Chem. 2015;407:8647–8659.
- Chan H, Shiea J, Cho Y-T, et al. Methods of analyzing peptide mixtures. 2009. https://www.google.ch/patents/WO2010129851A1?cl=en.Accessed 19 December 2017.
- Venkata SP, Khedkar A, Patil NS, et al. Process for the preparation of random polypeptides and employing circular dichroism as a guidance tool for the manufacture of glatiramer acetate. 2011. https://www.google.com/patents/WO2013065071A1?cl=zh. Accessed 19 December 2017.
- Driscoll DF, Nicoli DF. Analytical Methods for determining the size (distribution) in parenteral dispersions. In: Crommelin DJA, De Vlieger JSB, eds. Non-biological complex drugs. NY: AAPS/Springer Advances in Pharmaceutical Sciences series; 2015. p. 193–259.
- Conner JB, Bawa R, Nicholas JM, et al. Copaxone® in the era of biosimilars and nanosimilars. In: Edited by, Bawa R, Audette GF, Rubinstein I. Handbook of clinical nanomedicine: nanoparticles, imaging, therapy, and clinical applications Singapore: Pan Stanford Publishing; 2014; chapter 28. 1–43.
- Clogston JD, Patri AK. Zeta potential measurements. Methods Mol Biol. 2011;697:63–70.
- Hermeling S, Crommelin DJ, Schellekens H, et al. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res. 2004;21:897–903.
- Levin I, Zigman S, Komlosh A, et al. Development of flow imaging analysis for subvisible particle characterization in glatiramer acetate. J Pharm Sci. 2015;104:3977–3983.
- Wang W, Singh SK, Li N, et al. Immunogenicity of protein aggregates - Concerns and realities. Int J Pharm. 2012;431:1–11.
- D’Alessandro J, Garofalo K, Zhao G, et al. Demonstration of biological and immunological equivalence of a generic glatiramer acetate. CNS & Neurological Disorders - Drug Targets. 2017 16;16(6):714–723.
- 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.
- D’Alessandro JS, Duffner J, Pradines J, et al. Equivalent gene expression profiles between glatopa™ and Copaxone1. PLoS ONE. 2015;10:e0140299.
- Kolitz S, Hasson T, Towfic F, et al. Gene expression studies of a human monocyte cell line identify dissimilarities between differently manufactured glatiramoids. Sci Reports. 2015 5;10191:1–14.
- FDA, FDA draft guidance on glatiramer acetate injection. [ cited 2016 April]. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495029.pdf. Accessed 19 December 2017.
- TEVA white paper. Comments on regulatory science initiatives under the generic drug user fee amendments of 2015. 2015. FDA-2014-N-1168.
- Steinman L. Assessment of animal models for MS and demyelinating disease in the design of rational therapy. Neuron. 1999;24:511–514.
- Constantinescu CS, Farooqi N, O’Brien K, et al. Experimental autoimmune encephalomyelitis (EAE) as a model for multiple sclerosis (MS). Br J Pharmacol. 2011;164:1079–1106.
- Steinman L, Zamvil SS. Virtues and pitfalls of EAE for the development of therapies for multiple sclerosis. Trends Immunol. 2005;26:565–571.
- Johnson KP. Glatiramer acetate and the glatiramoid class of immunomodulator drugs in multiple sclerosis: an update. Expert Opin Drug Metab Toxicol. 2010;6:643–660.
- Crommelin DJA, Broich K, Holloway C, et al. The regulator’s perspective: how should new therapies and follow-on products for MS be clinically evaluated in the future? Multiple Sclerosis J. 2016;22:47–59.
- De Stefano N, Filippi M, Confavreux C, et al. The results of two multicenter, open-label studies assessing efficacy, tolerability and safety of protiramer, a high molecular weight synthetic copolymeric mixture, in patients with relapsing–remitting multiple sclerosis. Multiple Sclerosis. 2009;15:238–243.
- FDA, FDA approves first generic Copaxone to treat multiple sclerosis. 2015 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm443143.htm. Acccessed 19 December 2017.
- Wattjes MP, Rovira A, Miller D, et al. MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients. Nat Rev Neurol. 2015;11:597–606.
- EMA. Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis. 2015. EMA/CHMP/771815/2011, Rev. 2
- Langeskov-Christensen M, Bisson EJ, Finlayson ML, et al. Potential pathophysiological pathways that can explain the positive effects of exercise on fatigue in multiple sclerosis: a scoping review. J Neurol Sci. 2017;373:307–320.
- Ramagopalan SV, Dyment DA. What is next for the genetics of multiple sclerosis? Autoimmune Diseases. 2011; ID 519450.3.1–3.
- Ross C, Towfic F, Shankar J, et al. Association of a multi-SNP signature with response to Copaxone (glatiramer acetate) in a subset of patients and in multiple RRMS patient cohorts. ECTRIMS Online Library Ross C. 2016 Sep 14. abstract EP1421.
- Grampp G, Bonafede MPH, Felix T, et al. Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars. Expert Opin Drug Saf. 2015;14:1–12.
- Grampp G, Felix T. Pharmacovigilance considerations for biosimilars in the USA. BioDrugs. 2015;29:309–321.
- TEVA. Citizen petition requesting that FDA refrain from approving any abbreviated new drug application referencing Copaxone® (glatiramer acetate injection) until certain conditions are met. 2014. FDA-2014-P-0933-0001.