메뉴 건너뛰기




Volumn 12, Issue 3, 2009, Pages 211-218

Health economics of market access for biopharmaceuticals and biosimilars

Author keywords

Biopharmaceutical; Biosimilar; Health economics; Pricing; Registration; Reimbursement; Research and development

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALEMTUZUMAB; ALGLUCERASE; ALPHA INTERFERON; ALTEPLASE; BASILIXIMAB; BETA INTERFERON; BIOLOGICAL MARKER; BIOSIMILAR DRUG; BLOOD CLOTTING FACTOR 10; BLOOD CLOTTING FACTOR 7; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; CHOLERA VACCINE; DACLIZUMAB; DIPHTHERIA PERTUSSIS TETANUS VACCINE; FILGRASTIM RATIOPHARM; GAMMA INTERFERON; GENERIC DRUG; HEPATITIS B SURFACE ANTIGEN; HUMAN GROWTH HORMONE; IMIGLUCERASE; INSULIN ASPART; RATIOGRASTIM; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT FOLLITROPIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT INTERLEUKIN 2; RETEPLASE; TENECTEPLASE; TEVAGRASTIM; UNCLASSIFIED DRUG; UNINDEXED DRUG;

EID: 75149181512     PISSN: 13696998     EISSN: None     Source Type: Journal    
DOI: 10.3111/13696990903260094     Document Type: Note
Times cited : (17)

References (40)
  • 1
    • 0022783479 scopus 로고
    • Biotechnology: The view from the FDA
    • Young FE. Biotechnology: the view from the FDA. Health Matrix 1986;4:10-15.
    • (1986) Health Matrix , vol.4 , pp. 10-15
    • Young, F.E.1
  • 2
    • 0242270743 scopus 로고    scopus 로고
    • Defining and characterizing the late-stage biopharmaceutical pipeline
    • Nagle PC, Lugo TF, Nicita CA. Defining and characterizing the late-stage biopharmaceutical pipeline. Am J Manag Care 2003;9:S124-135.
    • (2003) Am J Manag Care , vol.9
    • Nagle, P.C.1    Lugo, T.F.2    Nicita, C.A.3
  • 3
    • 49449091372 scopus 로고    scopus 로고
    • IMS Health. London: IMS Health
    • IMS Health. IMS lifecycle R&D focus. London: IMS Health, 2007
    • (2007) IMS Lifecycle R&D Focus
  • 4
    • 33749422081 scopus 로고    scopus 로고
    • Market access for biopharmaceuticals: New challenges
    • Simon F. Market access for biopharmaceuticals: new challenges. Health Aff (Millwood) 2006;25:1363-1370
    • (2006) Health Aff (Millwood) , vol.25 , pp. 1363-1370
    • Simon, F.1
  • 6
    • 33645468877 scopus 로고    scopus 로고
    • Managing the expanded use of biologics across therapeutic areas: An example from b-cell targeted therapies
    • Cohen M, Morrow T, Penna P. Managing the expanded use of biologics across therapeutic areas: an example from b-cell targeted therapies. Am J Manag Care 2006;12:S24-37.
    • (2006) Am J Manag Care , vol.12
    • Cohen, M.1    Morrow, T.2    Penna, P.3
  • 9
    • 75149112660 scopus 로고    scopus 로고
    • Strategies for entering the biosimilar market
    • London: Biopharm Knowledge Publishing
    • Oldham T. Strategies for entering the biosimilar market. In: Biosimilars - Evolution or Revolution? London: Biopharm Knowledge Publishing, 2006.
    • (2006) Biosimilars - Evolution or Revolution?
    • Oldham, T.1
  • 10
    • 34548324706 scopus 로고    scopus 로고
    • The cost of biopharmaceutical R&D: Is biotech different?
    • DiMasi J, Grabowski H. The cost of biopharmaceutical R&D: is biotech different? Managerial and Decision Economics 2007;28:469-479
    • (2007) Managerial and Decision Economics , vol.28 , pp. 469-479
    • Dimasi, J.1    Grabowski, H.2
  • 12
    • 44449151539 scopus 로고    scopus 로고
    • Follow-on biologics: Data exclusivity and the balance between innovation and competition
    • Grabowski H. Follow-on biologics: data exclusivity and the balance between innovation and competition. Nat Rev Drug Discov 2008;7:479-488
    • (2008) Nat Rev Drug Discov , vol.7 , pp. 479-488
    • Grabowski, H.1
  • 13
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003;22:151-185
    • (2003) J Health Econ , vol.22 , pp. 151-185
    • Dimasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 14
    • 46149145516 scopus 로고    scopus 로고
    • Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
    • European Commission
    • European Commission. Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal of the European Union 2004;1(L 136/1 - L 136/33).
    • (2004) Official Journal of the European Union , vol.1
  • 15
    • 68649124703 scopus 로고    scopus 로고
    • European Generic Medicines Association. Brussels: European Generic Medicines Association
    • European Generic Medicines Association. EGA Handbook on Biosimilar Medicines. Brussels: European Generic Medicines Association, 2008.
    • (2008) EGA Handbook on Biosimilar Medicines
  • 17
    • 55349105870 scopus 로고    scopus 로고
    • Typical pitfalls in applications for marketing authorization of biotechnological products in Europe
    • Schneider CK, Schaffner-Dallmann G. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe. Nat Rev Drug Discov 2008;7:893-899
    • (2008) Nat Rev Drug Discov , vol.7 , pp. 893-899
    • Schneider, C.K.1    Schaffner-Dallmann, G.2
  • 21
    • 33749333428 scopus 로고    scopus 로고
    • Prices and availability of biopharmaceuticals: An international comparison
    • Danzon PM, Furukawa MF. Prices and availability of biopharmaceuticals: an international comparison. Health Aff (Millwood) 2006;25:1353-1362
    • (2006) Health Aff (Millwood) , vol.25 , pp. 1353-1362
    • Danzon, P.M.1    Furukawa, M.F.2
  • 22
    • 34748856993 scopus 로고    scopus 로고
    • The increasingly complex fourth hurdle for pharmaceuticals
    • Cohen J, Stolk E, Niezen M. The increasingly complex fourth hurdle for pharmaceuticals. Pharmacoeconomics 2007;25:727-734
    • (2007) Pharmacoeconomics , vol.25 , pp. 727-734
    • Cohen, J.1    Stolk, E.2    Niezen, M.3
  • 23
    • 0034945594 scopus 로고    scopus 로고
    • Health economic guidelines - Similarities, differences and some implications
    • Hjelmgren J, Berggren F, Andersson F. Health economic guidelines - similarities, differences and some implications. Value Health 2001;4:225-250
    • (2001) Value Health , vol.4 , pp. 225-250
    • Hjelmgren, J.1    Berggren, F.2    Andersson, F.3
  • 24
    • 33645826772 scopus 로고    scopus 로고
    • Economic and developmental considerations for pharmacogenomic technology
    • Vernon JA, Johnson SJ, Hughen WK, et al. Economic and developmental considerations for pharmacogenomic technology. Pharmacoeconomics 2006;24:335-343
    • (2006) Pharmacoeconomics , vol.24 , pp. 335-343
    • Vernon, J.A.1    Johnson, S.J.2    Hughen, W.K.3
  • 26
    • 45749123287 scopus 로고    scopus 로고
    • Multiple sclerosis risk-sharing: Four years on
    • Barham L. Multiple sclerosis risk-sharing: four years on. Pharma Pricing Reimbursement 2006;11:100-101
    • (2006) Pharma Pricing Reimbursement , vol.11 , pp. 100-101
    • Barham, L.1
  • 27
    • 33749345017 scopus 로고    scopus 로고
    • The market for follow-on biologics: How will it evolve?
    • Grabowski H, Cockburn I, Long G. The market for follow-on biologics: how will it evolve? Health Aff (Millwood) 2006;25:1291-1301
    • (2006) Health Aff (Millwood) , vol.25 , pp. 1291-1301
    • Grabowski, H.1    Cockburn, I.2    Long, G.3
  • 28
  • 29
    • 73549106371 scopus 로고    scopus 로고
    • International Society for Pharmacoeconomics and Outcomes Research. Lawrenceville, NJ: ISPOR
    • International Society for Pharmacoeconomics and Outcomes Research. Pharmacoeconomic Guidelines around the World. Lawrenceville, NJ: ISPOR, 2008.
    • (2008) Pharmacoeconomic Guidelines Around the World
  • 31
    • 1542753592 scopus 로고    scopus 로고
    • Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: A nationwide study of community practices
    • Lyman GH, Dale DC, Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol 2003;21:4524-4531
    • (2003) J Clin Oncol , vol.21 , pp. 4524-4531
    • Lyman, G.H.1    Dale, D.C.2    Crawford, J.3
  • 32
    • 0025835219 scopus 로고
    • Recombinant granulocyte colony-stimulating factor (rG-CSF). A review of its pharmacological properties and prospective role in neutropenic conditions
    • Hollingshead LM, Goa KL. Recombinant granulocyte colony-stimulating factor (rG-CSF). A review of its pharmacological properties and prospective role in neutropenic conditions. Drugs 1991;42:300-330
    • (1991) Drugs , vol.42 , pp. 300-330
    • Hollingshead, L.M.1    Goa, K.L.2
  • 33
    • 0036532256 scopus 로고    scopus 로고
    • Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: A meta-analysis
    • Lyman GH, Kuderer NM, Djulbegovic B. Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: a meta-analysis. Am J Med 2002;112:406-411
    • (2002) Am J Med , vol.112 , pp. 406-411
    • Lyman, G.H.1    Kuderer, N.M.2    Djulbegovic, B.3
  • 35
    • 0346100492 scopus 로고    scopus 로고
    • Economic evaluations of granulocyte colony-stimulating factor: In the prevention and treatment of chemotherapy-induced neutropenia
    • Esser M, Brunner H. Economic evaluations of granulocyte colony-stimulating factor: in the prevention and treatment of chemotherapy-induced neutropenia. Pharmacoeconomics 2003;21:1295-1313
    • (2003) Pharmacoeconomics , vol.21 , pp. 1295-1313
    • Esser, M.1    Brunner, H.2
  • 36
    • 75149178632 scopus 로고    scopus 로고
    • European Medicines Agency. London: European Medicines Agency
    • European Medicines Agency. Assessment report for Filgrastim Ratiopharm. London: European Medicines Agency, 2008.
    • (2008) Assessment Report for Filgrastim Ratiopharm
  • 37
    • 0043248410 scopus 로고    scopus 로고
    • A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer
    • Siena S, Piccart MJ, Holmes FA, et al. A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer. Oncol Rep 2003;10:715-724
    • (2003) Oncol Rep , vol.10 , pp. 715-724
    • Siena, S.1    Piccart, M.J.2    Holmes, F.A.3
  • 38
    • 41549115442 scopus 로고    scopus 로고
    • Economic analysis of prophylactic pegfilgrastim in adult cancer patients receiving chemotherapy
    • Eldar-Lissai A, Cosler LE, Culakova E, et al. Economic analysis of prophylactic pegfilgrastim in adult cancer patients receiving chemotherapy. Value Health 2008;11:172-179
    • (2008) Value Health , vol.11 , pp. 172-179
    • Eldar-Lissai, A.1    Cosler, L.E.2    Culakova, E.3
  • 39
    • 64249170087 scopus 로고    scopus 로고
    • Cost-effectiveness of pegfilgrastim versus 6-day filgrastim primary prophylaxis in patients with non-Hodgkin's lymphoma receiving CHOP-21 in United States
    • Lyman G, Lalla A, Barron R, et al. Cost-effectiveness of pegfilgrastim versus 6-day filgrastim primary prophylaxis in patients with non-Hodgkin's lymphoma receiving CHOP-21 in United States. Curr Med Res Opin 2009;25:401-411
    • (2009) Curr Med Res Opin , vol.25 , pp. 401-411
    • Lyman, G.1    Lalla, A.2    Barron, R.3
  • 40
    • 60349114096 scopus 로고    scopus 로고
    • Cost-effectiveness of primary versus secondary prophylaxis with pegfilgrastim in women with early-stage breast cancer receiving chemotherapy
    • Ramsey S, Liu Z, Boer R, et al. Cost-effectiveness of primary versus secondary prophylaxis with pegfilgrastim in women with early-stage breast cancer receiving chemotherapy. Value Health 2009;12:217-225
    • (2009) Value Health , vol.12 , pp. 217-225
    • Ramsey, S.1    Liu, Z.2    Boer, R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.