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Volumn 9, Issue 8, 2011, Pages 34-40

Generic biologics: A comparative analysis of regulatory review

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGIC; ERYTHROPOIETIN; GENERIC DRUG; GROWTH HORMONE; INSULIN; INTERFERON; NATURAL PRODUCT; UNCLASSIFIED DRUG;

EID: 80053197790     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review
Times cited : (10)

References (16)
  • 1
    • 77952417326 scopus 로고    scopus 로고
    • Pub. L. No. 11-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010. Pub. L. No. 111-152, 124 Stat. 1029
    • The Patient Protection and Affordable Care Act. Pub. L. No. 11-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010. Pub. L. No. 111-152, 124 Stat. 1029 (2010).
    • (2010) The Patient Protection and Affordable Care Act
  • 2
    • 69449083908 scopus 로고    scopus 로고
    • Potential Savings of Biogenerics in the United States
    • February
    • Miller S, Houts J. Potential Savings of Biogenerics in the United States. Express Scripts February 2007; www.express-scripts.com/research/studies/ pharmacybenefitresearch/specialtypharmacyservices/docs/ potentialSavingsBiogenericsUS.pdf.
    • (2007) Express Scripts
    • Miller, S.1    Houts, J.2
  • 4
    • 78649288377 scopus 로고    scopus 로고
    • The Future of Generic Biologics: Should the United States "Follow-On" the European Pathway?
    • Kaldre I. The Future of Generic Biologics: Should the United States "Follow-On" the European Pathway? Duke Law and Technology Review 2008; www.law.duke.edu/journals/dltr/articles/2008dltr0009.html.
    • (2008) Duke Law and Technology Review
    • Kaldre, I.1
  • 5
    • 8344222959 scopus 로고    scopus 로고
    • How Similar to "Biosimilars" Need to Be?
    • Schellekens H. How Similar to "Biosimilars" Need to Be? Nature Biotech. 22 2004: 1357-1358.
    • (2004) Nature Biotech. , vol.22 , pp. 1357-1358
    • Schellekens, H.1
  • 6
    • 33644952525 scopus 로고    scopus 로고
    • EMEA Committee for Medicinal Products for Human Use. 30 October
    • EMEA Committee for Medicinal Products for Human Use. Guideline on Similar Biological Medicinal Products. 30 October 2005.
    • (2005) Guideline on Similar Biological Medicinal Products
  • 7
    • 77954900211 scopus 로고    scopus 로고
    • Biogeneric Regulatory Policies in China and India: A Comparison Study
    • Guise JW, Carson BM. Biogeneric Regulatory Policies in China and India: A Comparison Study. Drug Information Journal 44, 2010: 55-57.
    • (2010) Drug Information Journal , vol.44 , pp. 55-57
    • Guise, J.W.1    Carson, B.M.2
  • 8
    • 84888453532 scopus 로고    scopus 로고
    • New Legal Pathway for Biosimilar Creates Opportunities and Challenges for Biological Manufacturers: A Guide to the Legislation
    • Wright Bonilla JD, Beaver NA. New Legal Pathway for Biosimilar Creates Opportunities and Challenges for Biological Manufacturers: A Guide to the Legislation. Bloomberg Law Reports 3(6) 2010.
    • (2010) Bloomberg Law Reports , vol.3 , Issue.6
    • Wright Bonilla, J.D.1    Beaver, N.A.2
  • 9
    • 47349126691 scopus 로고    scopus 로고
    • Biosimilars: Policy, Clinical, and Regulatory Considerations
    • July
    • Gottlieb S. Biosimilars: Policy, Clinical, and Regulatory Considerations. Am. J. Health-Sys. Pharm. 65(6) 15 July 2008.
    • (2008) Am. J. Health-Sys. Pharm. , vol.65 , Issue.6 , pp. 15
    • Gottlieb, S.1
  • 10
    • 34548147147 scopus 로고    scopus 로고
    • Basic facts about biosimilars
    • DOI 10.1159/000105133
    • Nowicki M. Basic Facts About Biosimilars. Kidney Blood Press Res. 30, 2007: 267-272. (Pubitemid 47482057)
    • (2007) Kidney and Blood Pressure Research , vol.30 , Issue.5 , pp. 267-272
    • Nowicki, M.1
  • 11
    • 84888474567 scopus 로고    scopus 로고
    • The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do We Go from Here?
    • pharmtech.findpharma.com/pharmtech/Formulation/Next-Steps-for-the-US- Biosimilar-Regulatory-Scheme/ArticleStandard/Article/detail/711302
    • Rosen D, Lian L. The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do We Go from Here? Pharmaceutical Technology Sourcing and Management 7(3); pharmtech.findpharma.com/pharmtech/Formulation/ Next-Steps-for-the-US-Biosimilar-Regulatory-Scheme/ArticleStandard/Article/ detail/711302).
    • Pharmaceutical Technology Sourcing and Management , vol.7 , Issue.3
    • Rosen, D.1    Lian, L.2
  • 13
    • 84888471524 scopus 로고    scopus 로고
    • Personal communication. Sky Xiaomin patent attorney, Scihead Patent Agent Co. Ltd., Guangdong, PR China
    • Personal communication. Sky Xiaomin patent attorney, Scihead Patent Agent Co. Ltd., Guangdong, PR China.
  • 14
    • 84888466634 scopus 로고    scopus 로고
    • Biosimilars Seen as a $3.7 Billion Drug Market by 2015
    • 29 March
    • Biosimilars Seen as a $3.7 Billion Drug Market by 2015. Reuters 29 March 2011; www.reuters.com/article/2011/03/28/pharmaceuticals-biosimilar.
    • (2011) Reuters
  • 15
    • 84888442612 scopus 로고    scopus 로고
    • Merck Buys Hanwha's Drug-Marketing Rights
    • 14 June
    • Merck Buys Hanwha's Drug-Marketing Rights. 14 June 2011, WSJ on-line; http://online.wsj.com/article/SB10001424052702303714704576383063665947924.html.
    • (2011) WSJ On-line
  • 16
    • 84888441875 scopus 로고    scopus 로고
    • Dealtalk: Race to Copy Biotech Drugs Creates Odd Bedfellows
    • 19 July
    • Dealtalk: Race to Copy Biotech Drugs Creates Odd Bedfellows. Reuters 19 July 2011; www.reuters.com/article/2011/06/22/us-pharmaceuticals-biotech- idUSTRE75L2M020110622.
    • (2011) Reuters


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.