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Volumn , Issue , 2009, Pages 763-777

Follow-On Protein Products: What, Where, When, How?

Author keywords

Currently marketed FOPPs human growth hormone and erythropoietin; Europe and United States regulatory landscape; Scientific and regulatory issues associated with generic protein therapeutics

Indexed keywords


EID: 84890974900     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470485408.ch32     Document Type: Chapter
Times cited : (4)

References (29)
  • 1
    • 19044397056 scopus 로고    scopus 로고
    • Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: Solving the mystery
    • Boven, K., J. Knight, F. Bader, J. Rossert, K.U. Eckardt, and N. Casadevall. 2005. Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: Solving the mystery. Nephrol. Dial. Transplant. 20 (Suppl 3): 33-40.
    • (2005) Nephrol. Dial. Transplant , vol.20 , Issue.SUPPL. 3 , pp. 33-40
    • Boven, K.1    Knight, J.2    Bader, F.3    Rossert, J.4    Eckardt, K.U.5    Casadevall, N.6
  • 2
    • 84890974609 scopus 로고    scopus 로고
    • Budget of the United States Government, Fiscal Year 2009, Washington, D.C.: U.S. Government Printing Office.
    • Budget of the United States Government, Fiscal Year 2009. 2008. Washington, D.C.: U.S. Government Printing Office.
    • (2008)
  • 3
    • 84891008916 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use, Guideline on Similar Biological Medicinal Products-CHMP/437/04. London: European Medicines Agency.
    • Committee for Medicinal Products for Human Use. 2005. Guideline on Similar Biological Medicinal Products-CHMP/437/04. London: European Medicines Agency.
    • (2005)
  • 4
    • 42049123626 scopus 로고    scopus 로고
    • Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues-Guidance on Similar Medicinal Products Containing Somatropin-EMEA/CHMP/BMWP/94528/2005
    • Committee for Medicinal Products for Human Use, a, London: European Medicines Agency.
    • Committee for Medicinal Products for Human Use. 2006a. Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues-Guidance on Similar Medicinal Products Containing Somatropin-EMEA/CHMP/BMWP/94528/2005. London: European Medicines Agency.
    • (2006)
  • 5
    • 74049160104 scopus 로고    scopus 로고
    • Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues-Guidance on Similar Medicinal Products Containing Erythropoietins-EMEA/CHMP/BMWP/94526/2005 Corr
    • Committee for Medicinal Products for Human Use, b, London: European Medicines Agency.
    • Committee for Medicinal Products for Human Use. 2006b. Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues-Guidance on Similar Medicinal Products Containing Erythropoietins-EMEA/CHMP/BMWP/94526/2005 Corr. London: European Medicines Agency.
    • (2006)
  • 6
    • 84891037617 scopus 로고    scopus 로고
    • Datamonitor, Biosimilars Series: Strategic Issues; Potential Remains Uncertain. New York: Datamonitor USA.
    • Datamonitor. 2007. Biosimilars Series: Strategic Issues; Potential Remains Uncertain. New York: Datamonitor USA.
    • (2007)
  • 7
    • 84891018123 scopus 로고    scopus 로고
    • Dr. Reddy's Laboratories Ltd, Dr. Reddy's Launches Reditux: Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma. Available at, (accessed March 24, 2008).
    • Dr. Reddy's Laboratories Ltd. 2007. Dr. Reddy's Launches Reditux: Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma. Available at http://www.drreddys.com/newsroom/2007yrnews.htm# (accessed March 24, 2008).
    • (2007)
  • 8
    • 84890990566 scopus 로고    scopus 로고
    • FDA/Center for Drug Evaluation and Research., Guidance for Industry: Applications Covered by Section 505(b)(2) (Draft). Available at, (accessed January 10, 2008).
    • FDA/Center for Drug Evaluation and Research. 1999. Guidance for Industry: Applications Covered by Section 505(b)(2) (Draft). Available at http://www.fda.gov/CDER/guidance/2853dft.htm#P109_2037 (accessed January 10, 2008).
    • (1999)
  • 9
    • 84891038566 scopus 로고    scopus 로고
    • FDA/Center for Drug Evaluation and Research., Frequently Asked Questions About Therapeutic Biological Products. Available at, (Accessed January 10, 2008).
    • FDA/Center for Drug Evaluation and Research. 2006. Frequently Asked Questions About Therapeutic Biological Products. Available at http://www.fda.gov/cder/biologics/qa.htm (Accessed January 10, 2008).
    • (2006)
  • 10
    • 84891040722 scopus 로고    scopus 로고
    • What Are Generic Drugs
    • FDA/Center for Drug Evaluation and Research., available at, (accessed January 10, 2008).
    • FDA/Center for Drug Evaluation and Research. 2008. What Are Generic Drugs. (available at http://www.fda.gov/cder/ogd (accessed January 10, 2008).
    • (2008)
  • 11
    • 84890999336 scopus 로고    scopus 로고
    • Generics: Lower Cost
    • Generic Pharmaceutical Association, Available at, (accessed January 10, 2008).
    • Generic Pharmaceutical Association. 2008. Generics: Lower Cost. Available at http://www.gphaonline.org/AM/Template.cfm?Section=FAQs&Template=/CM/HTMLDisplay.m&ContentID=2497 (accessed January 10, 2008).
    • (2008)
  • 12
    • 84891000213 scopus 로고    scopus 로고
    • GovTrack.us, S. 1695-110th Congress. Biologics Price Competition and Innovation Act of 2007. Available at , (accessed January 10, 2008).
    • GovTrack.us. 2007. S. 1695-110th Congress. Biologics Price Competition and Innovation Act of 2007. Available at http://www.govtrack.us/congress/bill.xpd?bill=s110-1695 (accessed January 10, 2008).
    • (2007)
  • 13
    • 84890972792 scopus 로고    scopus 로고
    • The Effect on Federal Spending of Legislation Creating a Regulatory Framework for Follow-on Biologics: Key Issues and Assumptions. White Paper. Available at, (accessed January 10, 2008).
    • Grabowski, H., I. Cockburn, G. Long, R. Mortimer, and S. Johnson. 2007. The Effect on Federal Spending of Legislation Creating a Regulatory Framework for Follow-on Biologics: Key Issues and Assumptions. White Paper. Available at http://www.bio.org/healthcare/followonbkg/Federal_Spending_of_followonbkg200709. pdf (accessed January 10, 2008).
    • (2007)
    • Grabowski, H.1    Cockburn, I.2    Long, G.3    Mortimer, R.4    Johnson, S.5
  • 14
    • 20344361935 scopus 로고    scopus 로고
    • Potential savings from substituting generic drugs for brand-name drugs: Medical expenditure panel survey, 1997-2000
    • Haas, J.S., K.A. Phillips, E.P. Gerstenberger, and A.C. Seger. 2005. Potential savings from substituting generic drugs for brand-name drugs: Medical expenditure panel survey, 1997-2000. Ann. Intern. Med. 142:891-897.
    • (2005) Ann. Intern. Med , vol.142 , pp. 891-897
    • Haas, J.S.1    Phillips, K.A.2    Gerstenberger, E.P.3    Seger, A.C.4
  • 15
    • 84944586434 scopus 로고    scopus 로고
    • Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics
    • Health Products and Food Branch, Ottawa: Health Canada.
    • Health Products and Food Branch. 2008. Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics. Ottawa: Health Canada.
    • (2008)
  • 16
    • 84890980221 scopus 로고    scopus 로고
    • GPhA Hails Introduction of Legislation to Bring Affordable Generic Biopharmaceutical Medicines to Consumers. Available at, (accessed January 10, 2008).
    • Hofelich, A. 2006. GPhA Hails Introduction of Legislation to Bring Affordable Generic Biopharmaceutical Medicines to Consumers. Available at http://www.gphaonline.org/AM/PrinterTemplate.cfm?Section= Media&Template=/CM/HTMLDisplay.cfm&ContentID=2849 (accessed January 10, 2008).
    • (2006)
    • Hofelich, A.1
  • 17
    • 45949108207 scopus 로고    scopus 로고
    • WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, April 19-20, 2007
    • Joung, J., J.S. Robertson, E. Griffiths, and I. Knezevic. 2008. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, April 19-20, 2007. Biologicals 36:269-276.
    • (2008) Biologicals , vol.36 , pp. 269-276
    • Joung, J.1    Robertson, J.S.2    Griffiths, E.3    Knezevic, I.4
  • 18
    • 84866363016 scopus 로고    scopus 로고
    • Production of erythropoietin
    • inventor; Kiren-Amgen, Inc., assignee. U.S. patent 5,547,933. August 20, 1996.
    • Lin, F.K., inventor; Kiren-Amgen, Inc., assignee. 1996. Production of erythropoietin. U.S. patent 5,547,933. August 20, 1996.
    • (1996)
    • Lin, F.K.1
  • 19
    • 0942284569 scopus 로고    scopus 로고
    • Lessons from Eprex for biogeneric firms
    • Louet, S. 2003. Lessons from Eprex for biogeneric firms. Nature Biotechnol. 21:956-957.
    • (2003) Nature Biotechnol , vol.21 , pp. 956-957
    • Louet, S.1
  • 20
    • 33645683454 scopus 로고    scopus 로고
    • Follow-on biologics: Ensuring continued innovation in the biotechnology industry
    • March/April
    • Manheim, B.S., Jr., P. Granahan, and K.J. Dow. 2006. Follow-on biologics: Ensuring continued innovation in the biotechnology industry. Biotech Industry March/April, 394-404.
    • (2006) Biotech Industry , pp. 394-404
    • Manheim Jr., B.S.1    Granahan, P.2    Dow, K.J.3
  • 21
    • 84890971964 scopus 로고    scopus 로고
    • The Future of Biosimilars. Key Opportunities and Emerging Therapies
    • London: Business Insights Ltd.
    • Marchant, J. 2007. The Future of Biosimilars. Key Opportunities and Emerging Therapies. London: Business Insights Ltd.
    • (2007)
    • Marchant, J.1
  • 22
    • 35348849594 scopus 로고    scopus 로고
    • Structure, production and function of erythropoietin: Implications for therapeutical use in cardiovascular disease
    • Mocini, D., T. Leone, M. Tubaro, M. Santini, and M. Penco. 2007. Structure, production and function of erythropoietin: Implications for therapeutical use in cardiovascular disease. Curr. Med. Chem. 14:2278-2287.
    • (2007) Curr. Med. Chem , vol.14 , pp. 2278-2287
    • Mocini, D.1    Leone, T.2    Tubaro, M.3    Santini, M.4    Penco, M.5
  • 23
    • 38049069357 scopus 로고    scopus 로고
    • Fractured European market undermines biosimilar launches
    • Moran, N. 2008. Fractured European market undermines biosimilar launches. Nature Biotechnol. 26:5-6.
    • (2008) Nature Biotechnol , vol.26 , pp. 5-6
    • Moran, N.1
  • 24
    • 84891026596 scopus 로고    scopus 로고
    • Public Health Service Act, 42 U.S.C. 262.
    • Public Health Service Act. 2006. 42 U.S.C. 262.
    • (2006)
  • 25
    • 84891011320 scopus 로고    scopus 로고
    • Dr. Reddy's launches Rituxan biosimilar in India. Breaking News on Drug Discovery. Available at, (accessed March 24, 2008).
    • Reymond, E. 2007. Dr. Reddy's launches Rituxan biosimilar in India. Breaking News on Drug Discovery. Available at http://www.drugresearcher.com/news/ng.asp?n=76261-dr-reddy-s-roche-biosimilars-india (accessed March 24, 2008).
    • (2007)
    • Reymond, E.1
  • 26
    • 77949560634 scopus 로고    scopus 로고
    • The Potential American Market for Generic Biological Treatments and the Associated Costs Savings
    • Available at:, (accessed August 14, 2008).
    • Shapiro, R.J., K. Singh, and M. Mukim. 2008. The Potential American Market for Generic Biological Treatments and the Associated Costs Savings. Available at: www.insmed.com/pdf/Biogeneric_Savings.pdf (accessed August 14, 2008).
    • (2008)
    • Shapiro, R.J.1    Singh, K.2    Mukim, M.3
  • 27
    • 84891032313 scopus 로고    scopus 로고
    • Follow-on Protein Products
    • Statement of Dr. Janet Woodcock before the U.S. House of Representatives, March 26, 2007,, Available at, (accessed January 10, 2008).
    • Woodcock, J. 2007. Statement of Dr. Janet Woodcock before the U.S. House of Representatives, March 26, 2007, "Follow-on Protein Products". Available at http://www.fda.gov/ola/2007/protein32607.html (accessed January 10, 2008).
    • (2007)
    • Woodcock, J.1
  • 29
    • 41149176979 scopus 로고    scopus 로고
    • WHO Informal Consultation on International Nonproprietary Names (INN) Policy for Biosimilar Products
    • World Health Organization., Available at, (accessed March 24, 2008).
    • World Health Organization. 2006. WHO Informal Consultation on International Nonproprietary Names (INN) Policy for Biosimilar Products. Available at http://www.who.int/medicines/services/inn/BiosimilarsINN_ReportSept2006.pdf (accessed March 24, 2008).
    • (2006)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.