The 47 references in paper D. Goryachev V., M. Telnykh Yu., N. Bunyatyan D., Д. Горячев В., М. Тельных Ю., Н. Бунятян Д. (2018) “Регуляторные подходы к оценке биоаналогов для лечения ревматических заболеваний // Regulatory approaches to evaluation of biosimilars for treatment of rheumatic diseases” / spz:neicon:vedomostincesmp:y:2017:i:3:p:155-163

1
The Federal Law of the Russian Federation of 12.04.2010 ¹ 61-FZ «On Circulation of Medicines». Available from: https://goo.gl/ JgCdAv (in Russian).
(check this in PDF content)
2
Stateregisterofmedicines[Internet].Availablefrom: https://grls.rosminzdrav.ru (in Russian).
(check this in PDF content)
3
U. S. Food and Drug Administration. Biosimilars. Available from: https:// goo.gl/Xy3HsL.
(check this in PDF content)
4
European Medicines Agency. Biosimilar Medicines. Available from: https:// goo.gl/JxefFK.
(check this in PDF content)
5
Guidline on similar biological medicinal products. Available from: https:// goo.gl/XdoSRo.
(check this in PDF content)
6
Taylor L. Over 700 biosimilars now in development worldwide: report. Pharma Times digital. 30 September, 2014. Available from: https:// goo.gl/2hzMGT.
(check this in PDF content)
7
Guidelines on evaluation of similar biotherapeutic products. Available from: https:// goo.gl/dFbGwD.
(check this in PDF content)
8
Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014; 73(1): 198–206.
(check this in PDF content)
9
Woodcock J. Biosimilar implementation: a progress report from FDA. 2015. Available from: http:// www.fda.gov/NewsEvents/Testimony/ucm463036.htm.
(check this in PDF content)
10
FederalFood,DrugandCosmeticAct.Availablefrom: https:// goo.gl/4xHjd7.
(check this in PDF content)
11
Public Health Service Act. Available from: https:// legcounsel.house.gov/Comps/PHSA-merged.pdf.
(check this in PDF content)
12
Implementation of the Biologics Price Competition and Innovation Act of 2009. Available from: https:// goo.gl/Ai3RUq.
(check this in PDF content)
13
Biosimilars: Questions and answers regarding the implementation of the Biologics Price Competition and Innovation Act of 2009 [Internet]. Available from: http://www.pharmadvisor.ru/document/ tr3698 (in Russian).
(check this in PDF content)
14
Christl L. Biologics Price Competition and Innovation Act of 2009: FDA’s overview of the regulatory guidance for the development and approval of biosimilar products in the US. Available from: https:// goo.gl/iKfcq8.
(check this in PDF content)
15
Guidance on evaluation of medicines. V. IV. Moscow: Poligraf-Plus; 2014 (in Russian).
(check this in PDF content)
16
Goel N, Chance K. The biosimilar landscape: a systematic review of its current status. Arthritis Rheum. 2014; 66(Suppl 11): S662.
(check this in PDF content)
17
Aerts LA, De Smet K, Reichmann G, van der Laan JW, Schneider CK. Biosimilars entering the clinic without animal studies. A paradigm shift in the European Union. MAbs 2014; 6(5): 1155–62.
(check this in PDF content)
18
Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014; 16(1): 22–6.
(check this in PDF content)
19
Kimball AB, Leonardi C, Stahle M, Gulliwer W, Chevrier M, Fakharzadeh S, et al. Demography, baseline disease characteristics and treatment history of patients with psoriasis enrolled in a multicentre, prospective, disease-based registry (PSOLAR). Br J Dermatol.
(check this in PDF content)
20
4; 171(1): 137–47. 20. European Medicines Agency. Guideline on similar biological medicinal products. 2014. Available from: https:// goo.gl/2X5hXM.
(check this in PDF content)
21
Schmitz S, Adams R, Walsh C. The use of continuous data versus binary data in MTC models: A case study in rheumatoid arthritis. BMC Med Res Methodol 2012; (12): 167.
(check this in PDF content)
22
Lai Z, La Noce A. Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example. RMD Open 2016; 2(1): e000154.
(check this in PDF content)
23
Cohen SB, Genovese MC, Choy EH, Perez-Ruis F, Pablos JL, Zhang N, et al. Randomized, double-blind, phase 3 study of efficacy and safety of ABP 501 compared with adalimumab in subjects with moderate to severe rheumatoid arthritis. https:// goo.gl/qAg3Mv.
(check this in PDF content)
24
Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003; 48(1): 35–45.
(check this in PDF content)
25
Press relies, April 5, 2016. FDA approvesInflectra, a biosimilar to Remicade. Available from: https:// goo.gl/yrd6Em.
(check this in PDF content)
26
Grabowski D, Henderson B, Lam D, Keystone EC, Thorne C, Jamal S, et al. Attitudes towards subsequent entry biologics/biosimilars: a survey of Canadian rheumatologists. Clin Rheumatol 2015; 34(8): 1427–33.
(check this in PDF content)
27
Australian approval for infliximab biosimilar. Available from: https:// goo.gl/qzMJaT.
(check this in PDF content)
28
Wang J, Chow S-C. On the regulatory approval pathway of biosimilar products. Pharmaceuticals 2012; 5(4): 353–68.
(check this in PDF content)
29
Press relies, April 5, 2016. FDA approvesInflectra, a biosimilar to Remicade. Available from: https:// goo.gl/cfrX4X.
(check this in PDF content)
30
Title VII: Improving access to innovative medical therapies. Subtitle A: Biologic Price Competition and Innovation. 2010. Available from: https:// goo.gl/qswQeT.
(check this in PDF content)
31
Danese S, Gomollon F. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohn’s Colitis 2013; 7(7): 586–9.
(check this in PDF content)
32
Rompas S, Goss T, Amanuel S, Coutino V, Lai Z, Antonini P, et al. Demonstrating value for biosimilars: a conceptual framework. Am Health Drug Benefits 2015; 8(3): 129–39.
(check this in PDF content)
33
Teixeira FV. First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society. GaBI Journal 2016; 5(1): 4–5.
(check this in PDF content)
34
Murphy C, Sugrue K, Mohamad G, McCarthy J, Buckley M. Biosimilar but not the same. J Crohn’s Colitis 2015; 9(Suppl 1): S331–2.
(check this in PDF content)
35
U. S. Food and Drug Administration. Draft guidance for industry. Non-inferiorityclinicaltrials.2016.Availablefrom: https:// goo.gl/csfW1o.
(check this in PDF content)
36
European Medicines Agency. Guideline on the choice of the non-inferiority margin. 2005. Available from: https:// goo.gl/nc39WD.
(check this in PDF content)
37
Grabowski D, Henderson B, Lam D, Keystone EC, Thorne C, Jamal S, et al. Attitudes towards subsequent entry biologics/biosimilars: a survey of Canadian rheumatologists. Clin Rheumatol 2015; 34(8): 1427–33.
(check this in PDF content)
38
Kolesnikova EYu. Pharmacoepidemiological studies of adverse reactions of developed drugs. Safety and Risk of Pharmacotherapy 2014; 3(4): 27–30 (in Russian).
(check this in PDF content)
39
ICH E10. Harmonised Tripartite Guideline: Choice of Control Group and Related Issues in Clinical Trials E10. 20 July 2000. Available from: https:// goo.gl/WTDtYQ.
(check this in PDF content)
40
ICH E9. Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials E9. 5 Feb 1997. Available from: https:// goo.gl/AUtbxi.
(check this in PDF content)
41
Guidance on clinical evaluation of medicines. Part 1. Moscow: Grif i K;2013 (in Russian).
(check this in PDF content)
42
Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis. 2013; 72(10): 1589–93.
(check this in PDF content)
43
Maini R, St Clair EW, Breedveld F, Furst D, Kalden J. Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999; 354(9194): 1932–9.
(check this in PDF content)
44
Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017; 76(1): 58–64.
(check this in PDF content)
45
Emery P, Vencovsky, J, Sylwestrzak A, Leszczynski P, Porawska W, Baranauskaite A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017; 76(1): 51–7.
(check this in PDF content)
46
Jani RH, Gupta R, Bhatia G, Rathi G, Ashok Kumar P, Sharma R, et al. A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis. 2016; 19(11): 1157–68.
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47
Kay J, Chopra A, Chandrashekara S, Wyand M. OP0012 A Phase 3, randomized, double-blind, active comparator study of the efficacy and safety of Bow015, a biosimilar Infliximab, in patients with active rheumatoid arthritis on stable Methotrexate doses. Ann Rheum Dis. 2014; 73(Suppl 2): 64.
(check this in PDF content)