References
- European Medicines Agency. Enbrel. Authorisation details. EMEA/H/C/000262. European Medicines Agency; 2000 Feb 2 [accessed 2017 March 22]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000262/human_med_000764.jsp&mid=WC0b01ac058001d124.
- Pfizer. Enbrel (etanercept) Summary of Product Characteristics. European Medicines Agency; 2010 Feb [accessed 2017 March 22]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000262/WC500027361.pdf.
- Scott LJ. Etanercept: a review of its use in autoimmune inflammatory diseases. Drugs. 2014;74:1379–410. doi:10.1007/s40265-014-0258-9. PMID:25034360.
- Maksymowych WP, Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Van den Bosch F, Logeart I, Wajdula J, Jones H, et al. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study. Ann Rheum Dis. 2016;75:1328–35. doi:10.1136/annrheumdis-2015-207596. PMID:26269397.
- Windschall D, Müller T, Becker I, Horneff G. Safety and efficacy of etanercept in children with the JIA categories extended oligoarthritis, enthesitis-related arthritis and psoriasis arthritis. Clin Rheumatol. 2015;34:61–9. doi:10.1007/s10067-014-2744-6. PMID:25034081.
- Scallon B, Cai A, Solowski N, Rosenberg A, Song XY, Shealy D, Wagner C. Binding and functional comparisons of two types of tumor necrosis factor antagonists. J Pharmacol Exp Ther. 2002;301:418–26. doi:10.1124/jpet.301.2.418. PMID:11961039.
- Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013;72:315–8. doi:10.1136/annrheumdis-2012-202941. PMID:23390018.
- European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process. Non-clinical and clinical issues. EMEA/CHMP/BMWP/101695/2006. London, UK: European Medicines Agency; 2007 July 19 [accessed 2017 March 22]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003935.pdf..
- Vezér B, Buzás Z, Sebeszta M, Zrubka Z. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents. Curr Med Res Opin. 2016;32:829–34. doi:10.1185/03007995.2016.1145579. PMID:26808864.
- International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Comparability of biotechnological/biological products subject to changes in their manufacturing process. Q5E. International Conference on Harmonisation; 2004 Nov 18 [accessed 2017 March 22]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf..
- Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29:310–2. doi:10.1038/nbt.1839. PMID:21478841.
- Sandoz. Arthritis Advisory Committee Briefing Document. GP2015 (Proposed INN: etanercept) Biosimilar. US Food & Drug Administration. Silver Spring, MD.; 2016 June 6 [accessed 2017 March 22]. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510494.pdf.
- European Medicines Agency. Enbrel: Procedural steps taken and scientific information after the authorisation. London (UK): European Medicines Agency; 2017. [accessed 2017 March 22]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/000262/WC500027366.pdf.
- Grampp G, Ramanan S. Managing unexpected events in the manufacturing of biologic medicines. Biodrugs. 2013;27:305–16. doi:10.1007/s40259-013-0018-5. PMID:23529766.
- US Food & Drug Administration. Enbrel® (etanercept) FDA approval letter. Rockville (MD) US: US Food & Drug Administration; 1998. Nov 2 [accessed 2017 March 22]. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/etanimm110298L.htm..
- Moreland LW, Weinblatt ME, Keystone EC, Kremer JM, Martin RW, Schiff MH, Whitmore JB, White BW. Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience. J Rheumatol. 2006;33:854–61. PMID:16541481.
- Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011;63:373–82. PMID:20957659.
- Gibofsky A, Palmer WR, Keystone EC, Schiff MH, Feng J, McCroskery P, Baumgartner SW, Markenson JA. Rheumatoid arthritis disease-modifying antirheumatic drug intervention and utilization study: safety and etanercept utilization analyses from the RADIUS 1 and RADIUS 2 registries. J Rheumatol. 2011;38:21–8. doi:10.3899/jrheum.100347. PMID:20952478.
- Leonardi C, Strober B, Gottlieb AB, Elewski BE, Ortonne JP, van de Kerkhof P, Chiou CF, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. J Drugs Dermatol. 2010;9:928–37. PMID:20684143.
- Papp KA, Poulin Y, Bissonnette R, Bourcier M, Toth D, Rosoph L, Poulin-Costello M, Setterfield M, Syrotuik J. Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population. J Am Acad Dermatol. 2012;66:e33–45. doi:10.1016/j.jaad.2010.07.026. PMID:20850895.
- Kimball AB, Rothman KJ, Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, et al. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015;72:115–22. doi:10.1016/j.jaad.2014.08.050. PMID:25264239.
- International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Specifications: test procedures and acceptance criteria for biotechnological/biological products. Q6B. International Conference on Harmonisation; 1999 March 10 [accessed 2017 Aug 16]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf..