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Volumn 26, Issue 3, 2012, Pages 177-184

Comparative pharmacokinetics of HD203, a biosimilar of etanercept, with marketed etanercept (Enbrel®): A double-blind, single-dose, crossover study in healthy volunteers

Author keywords

Bioequivalence; Comparative pharmacokinetics; Etanercept

Indexed keywords

BIOSIMILAR AGENT; ETANERCEPT; HD 203; UNCLASSIFIED DRUG;

EID: 84860619510     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.2165/11631860-000000000-00000     Document Type: Article
Times cited : (34)

References (25)
  • 2
    • 84860604626 scopus 로고    scopus 로고
    • online]. Available from URL Accessed 2012 Mar 21]
    • Public Health Service (PHS) Act in Section 262: Regulation of biological products [online]. Available from URL: http://www.fda.gov/Regulatory Information/Legislation/FederalFoodDrugandCosmeticActFDCAct/Signif icantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm [Accessed 2012 Mar 21]
    • Public Health Service (PHS) Act in Section 262: Regulation of biological products
  • 3
    • 64149127559 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: Single-blind, randomized, crossover trial
    • Lubenau H, Bias P, Maly AK, et al. Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial. BioDrugs 2009; 23 (1): 43-51
    • (2009) Bio. Drugs , vol.23 , Issue.1 , pp. 43-51
    • Lubenau, H.1    Bias, P.2    Maly, A.K.3
  • 4
    • 79953165772 scopus 로고    scopus 로고
    • Evaluation of process efficiency and bioequivalence of biosimilar recombinant human chorionic gonadotropin (rhCG)
    • Seo KS, Yoon JW, Na KH, et al. Evaluation of process efficiency and bioequivalence of biosimilar recombinant human chorionic gonadotropin (rhCG). BioDrugs 2011; 25 (2): 115-27
    • (2011) Bio. Drugs , vol.25 , Issue.2 , pp. 115-127
    • Seo, K.S.1    Yoon, J.W.2    Na, K.H.3
  • 5
    • 78449273913 scopus 로고    scopus 로고
    • Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: Two comparative phase 1 randomized studies and population pharmacokinetic analysis
    • Nov
    • Stanhope R, Sorgel F, Gravel P, et al. Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis. J Clin Pharmacol 2010 Nov; 50 (11): 1339-48
    • (2010) J. Clin. Pharmacol. , vol.50 , Issue.11 , pp. 1339-1348
    • Stanhope, R.1    Sorgel, F.2    Gravel, P.3
  • 6
    • 82155188444 scopus 로고    scopus 로고
    • Biosimilars: A regulatory perspective from America
    • May 12
    • Kay J. Biosimilars: a regulatory perspective from America. Arthritis Res Ther 2011 May 12; 13 (3): 112
    • (2011) Arthritis Res. Ther. , vol.13 , Issue.3 , pp. 112
    • Kay, J.1
  • 7
    • 84860636933 scopus 로고    scopus 로고
    • Seoul: Hanwha Chemical Co. (Data on file)
    • Investigator's Brochure of HD203. Seoul: Hanwha Chemical Co., 2010. (Data on file)
    • (2010) Investigator's Brochure of HD203
  • 9
    • 0017743953 scopus 로고
    • Influence of height, weight and obesity on risk of breast cancer in an unselected Swedish population
    • Dec
    • Adami HO, Rimsten A, Stenkvist B, et al. Influence of height, weight and obesity on risk of breast cancer in an unselected Swedish population. Br J Cancer 1977 Dec; 36 (6): 787-92
    • (1977) Br. J. Cancer , vol.36 , Issue.6 , pp. 787-792
    • Adami, H.O.1    Rimsten, A.2    Stenkvist, B.3
  • 11
    • 33745232468 scopus 로고    scopus 로고
    • Bioequivalence of liquid and reconstituted lyophilized etanercept subcutaneous injections
    • Jun
    • Sullivan JT, Ni L, Sheelo C, et al. Bioequivalence of liquid and reconstituted lyophilized etanercept subcutaneous injections. J Clin Pharmacol 2006 Jun; 46 (6): 654-61
    • (2006) J. Clin. Pharmacol. , vol.46 , Issue.6 , pp. 654-661
    • Sullivan, J.T.1    Ni, L.2    Sheelo, C.3
  • 12
    • 25844468887 scopus 로고    scopus 로고
    • Guideline on bioanalytical method validation. European Medicines Agency [online]. Available from URL Accessed 2012 Mar 27
    • Commitee for Medicinal Products for Human Use. Guideline on bioanalytical method validation. European Medicines Agency, 2011 [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/Sci entific-guideline/2011/08/WC500109686.pdf [Accessed 2012 Mar 27]
    • (2011) Commitee for Medicinal Products for Human Use
  • 13
    • 0032825293 scopus 로고    scopus 로고
    • Open questions on bioequivalence: Some problems and some solutions
    • Oct
    • Marzo A. Open questions on bioequivalence: some problems and some solutions. Pharmacol Res 1999 Oct; 40 (4): 357-68
    • (1999) Pharmacol. Res. , vol.40 , Issue.4 , pp. 357-368
    • Marzo, A.1
  • 14
    • 0034918119 scopus 로고    scopus 로고
    • Proof of efficacy trials: Cross-over versus parallel-group
    • May discussion 9-51
    • Richens A. Proof of efficacy trials: cross-over versus parallel-group. Epilepsy Res 2001 May; 45 (1-3): 43-7; discussion 9-51
    • (2001) Epilepsy Res. , vol.45 , Issue.1-3 , pp. 43-47
    • Richens, A.1
  • 15
    • 22344444432 scopus 로고    scopus 로고
    • Mechanisms of differential immunogenicity of tumor necrosis factor inhibitors
    • Mar
    • Anderson P, Louie J, Lau A, et al. Mechanisms of differential immunogenicity of tumor necrosis factor inhibitors. Curr Rheumatol Rep 2005 Mar; 7 (1): 3-9
    • (2005) Curr. Rheumatol. Rep. , vol.7 , Issue.1 , pp. 3-9
    • Anderson, P.1    Louie, J.2    Lau, A.3
  • 16
    • 77749277255 scopus 로고    scopus 로고
    • Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics
    • Mar
    • Looper YJ. Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics. Curr Opin Drug Discov Devel 2010 Mar; 13 (2): 247-56
    • (2010) Curr. Opin. Drug Discov. Devel. , vol.13 , Issue.2 , pp. 247-256
    • Looper, Y.J.1
  • 17
    • 84860627415 scopus 로고    scopus 로고
    • Korea Food Guidelines on the evaluation of biosimilar products Jul [online]. Available from URL Accessed 2012 Mar 21
    • Korea Food and Drug Administration. Guidelines on the evaluation of biosimilar products, 2009 Jul [online]. Available from URL: http://www.kfda. go.kr/index.kfda?mid=226 [Accessed 2012 Mar 21]
    • (2009) Drug Administration
  • 18
    • 6344261597 scopus 로고    scopus 로고
    • Absence of a clinically relevant interaction between etanercept and digoxin
    • Nov
    • Zhou H, Parks V, Patat A, et al. Absence of a clinically relevant interaction between etanercept and digoxin. J Clin Pharmacol 2004 Nov; 44 (11): 1244-51
    • (2004) J. Clin. Pharmacol. , vol.44 , Issue.11 , pp. 1244-1251
    • Zhou, H.1    Parks, V.2    Patat, A.3
  • 19
    • 1942508209 scopus 로고    scopus 로고
    • Absence of a pharmacokinetic interaction between etanercept and warfarin
    • May
    • Zhou H, Patat A, Parks V, et al. Absence of a pharmacokinetic interaction between etanercept and warfarin. J Clin Pharmacol 2004 May; 44 (5): 543-50
    • (2004) J. Clin Pharmacol. , vol.44 , Issue.5 , pp. 543-550
    • Zhou, H.1    Patat, A.2    Parks, V.3
  • 20
    • 33644990468 scopus 로고    scopus 로고
    • The comparability of etanercept pharmacokinetics in healthy Japanese and American subjects
    • Apr
    • Kawai S, Sekino H, Yamashita N, et al. The comparability of etanercept pharmacokinetics in healthy Japanese and American subjects. J Clin Pharmacol 2006 Apr; 46 (4): 418-23
    • (2006) J. Clin. Pharmacol. , vol.46 , Issue.4 , pp. 418-423
    • Kawai, S.1    Sekino, H.2    Yamashita, N.3
  • 21
    • 0033975145 scopus 로고    scopus 로고
    • The pharmacokinetics of etanercept in healthy volunteers
    • Feb
    • Korth-Bradley JM, Rubin AS, Hanna RK, et al. The pharmacokinetics of etanercept in healthy volunteers. Ann Pharmacother 2000 Feb; 34 (2): 161-4
    • (2000) Ann. Pharmacother. , vol.34 , Issue.2 , pp. 161-164
    • Korth-Bradley, J.M.1    Rubin, A.S.2    Hanna, R.K.3
  • 22
    • 79955806736 scopus 로고    scopus 로고
    • Integrated population pharmacokinetics of etanercept in healthy subjects and patients with rheumatoid arthritis and ankylosing spondylitis
    • Zhou SY, Shu C, Korth-Bradley J, et al. Integrated population pharmacokinetics of etanercept in healthy subjects and patients with rheumatoid arthritis and ankylosing spondylitis. J Clin Pharmacol 2011; 51 (6): 864-75
    • (2011) J. Clin. Pharmacol. , vol.51 , Issue.6 , pp. 864-875
    • Zhou, S.Y.1    Shu, C.2    Korth-Bradley, J.3
  • 23
    • 78149403810 scopus 로고    scopus 로고
    • Population pharmacokinetics of rhtnfr-fc in healthy chinese volunteers and in chinese patients with ankylosing spondylitis
    • Nov
    • Fang Y, Li LJ, Wang R, et al. Population pharmacokinetics of rhTNFR-Fc in healthy Chinese volunteers and in Chinese patients with ankylosing spondylitis. Acta Pharmacol Sin 2010 Nov; 31 (11): 1500-7
    • (2010) Acta. Pharmacol. Sin. , vol.31 , Issue.11 , pp. 1500-1507
    • Fang, Y.1    Li, L.J.2    Wang, R.3
  • 24
    • 79955806736 scopus 로고    scopus 로고
    • Integrated population pharmacokinetics of etanercept in healthy subjects and in patients with rheumatoid arthritis and ankylosing spondylitis
    • Jun
    • Zhou SY, Shu C, Korth-Bradley J, et al. Integrated population pharmacokinetics of etanercept in healthy subjects and in patients with rheumatoid arthritis and ankylosing spondylitis. J Clin Pharmacol 2011 Jun; 51 (6): 864-75
    • (2011) J. Clin. Pharmacol. , vol.51 , Issue.6 , pp. 864-875
    • Zhou, S.Y.1    Shu, C.2    Korth-Bradley, J.3
  • 25
    • 84860636932 scopus 로고    scopus 로고
    • Randomized double-blind parallel trial to evaluate equivalence in efficacy and safety of HD203 and Enbrel in RA patients [Clinical- Trials.gov identifier NCT01270997
    • Hanwha Chemical online Available from URL Accessed 2012 Mar 21]
    • Hanwha Chemical. Randomized double-blind parallel trial to evaluate equivalence in efficacy and safety of HD203 and Enbrel in RA patients [Clinical- Trials.gov identifier NCT01270997]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://www/clinicaltrials. gov [Accessed 2012 Mar 21]
    • US National Institutes of Health Clinical Trials.Gov.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.