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Volumn 12, Issue 1, 2010, Pages 17-31

Biosimilar drugs: Economic issues and Italian market perspectives;Biosimilari Aspetti economici e prospettive per il mercato italiano

Author keywords

[No Author keywords available]

Indexed keywords

DRUG COST; DRUG MARKETING; ECONOMIC ASPECT; IMMUNOGENICITY; MEDICAL RESEARCH; PROSPECTIVE PRICING; REVIEW; SYNTHESIS;

EID: 77953862251     PISSN: 15909158     EISSN: 20356137     Source Type: Journal    
DOI: 10.1007/BF03320527     Document Type: Review
Times cited : (3)

References (44)
  • 2
    • 77953842727 scopus 로고    scopus 로고
    • Estimating US savings from follow-on biologics
    • Avalere Health. OHE Conference. London, June 2
    • Avalere Health. Estimating US savings from follow-on biologics. Biosimilars: how much entry and price competition will result. OHE Conference. London, June 2, 2009
    • (2009) Biosimilars: How Much Entry and Price Competition Will Result
  • 3
    • 67349088979 scopus 로고    scopus 로고
    • Industry views of biosimilar development in Japan
    • Horikawa H, Tsubouchi M, Kawakami K. Industry views of biosimilar development in Japan. Health Policy 2009; 91: 189-194
    • (2009) Health Policy , vol.91 , pp. 189-194
    • Horikawa, H.1    Tsubouchi, M.2    Kawakami, K.3
  • 5
    • 33645697832 scopus 로고    scopus 로고
    • The quantity and the quality of worldwide new drug introductions 1982-2003
    • Grabowski H, Wang R. The quantity and the quality of worldwide new drug introductions 1982-2003. Health Aff 2006; 25: 452-460
    • (2005) Health Aff , vol.25 , pp. 452-460
    • Grabowski, H.1    Wang, R.2
  • 7
    • 77953830707 scopus 로고    scopus 로고
    • Report annuale per il. Milano: Cergas Bocconi
    • Osservatorio Farmaci. Report 23. Report annuale per il. Milano: Cergas Bocconi, 2008
    • (2008) Osservatorio Farmaci. Report , vol.23
  • 8
    • 36348937220 scopus 로고    scopus 로고
    • Biosimilar drugs: Concerns and opportunities
    • Genazzani A, Biggio G, Caputi AP, et al. Biosimilar drugs: concerns and opportunities. Biodrugs 2007; 21: 351-356
    • (2007) Biodrugs , vol.21 , pp. 351-356
    • Genazzani, A.1    Biggio, G.2    Caputi, A.P.3
  • 10
    • 41149090136 scopus 로고    scopus 로고
    • Biotecnológicos y bio-similares: El proceso es el producto
    • Perayre Badia M, Leiva E, Jódar R. Biotecnológicos y bio-similares: El proceso es el producto. Atención Farmacéutica 2007; 9: 358-364
    • (2007) Atención Farmacéutica , vol.9 , pp. 358-364
    • Perayre Badia, M.1    Leiva, E.2    Jódar, R.3
  • 12
    • 34748907902 scopus 로고    scopus 로고
    • Through the looking glass: The protein science of biosimilars
    • Goldsmith D, Kuhlmann M, Covic A. Through the looking glass: the protein science of biosimilars. Clin Exp Nephrol 2007; 11: 191-195
    • (2007) Clin Exp Nephrol , vol.11 , pp. 191-195
    • Goldsmith, D.1    Kuhlmann, M.2    Covic, A.3
  • 13
    • 58149389419 scopus 로고    scopus 로고
    • Why biosimilars will have a smaller competitive edge than generics
    • Blackstone AE, Fuhr Jr JP. Why biosimilars will have a smaller competitive edge than generics. Journal of Health Care Finance 2008; 35: 84-95
    • (2008) Journal of Health Care Finance , vol.3 , pp. 84-95
    • Blackstone, A.E.1    Fuhr Jr., J.P.2
  • 14
    • 33847396966 scopus 로고    scopus 로고
    • Biosimilars: The impact of their heterogeneity on regulatory approval
    • Tsiftsoglou AS. Biosimilars: the impact of their heterogeneity on regulatory approval. Nat Rev Drug Discov 2007; 6
    • (2007) Nat Rev Drug Discov , vol.6
    • Tsiftsoglou, A.S.1
  • 15
    • 19044395847 scopus 로고    scopus 로고
    • Follow-on biologics: Challenges of the "next Generation"
    • Schellekens H. Follow-on biologics: challenges of the "next Generation". Nephrol Dial Transplant 2005; 20 Suppl. 4: iv31-6
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 4
    • Schellekens, H.1
  • 16
    • 77953841879 scopus 로고    scopus 로고
    • The US Data Exclusivity debate: Balancing innovation, incentives and cost savings. Biosimilars: How much entry and price competition will result
    • London, June 2
    • Grabowski HG. The US Data Exclusivity debate: balancing innovation, incentives and cost savings. Biosimilars: how much entry and price competition will result. OHE Conference. London, June 2, 2009
    • (2009) OHE Conference
    • Grabowski, H.G.1
  • 17
    • 33749345017 scopus 로고    scopus 로고
    • The market for follow-on biologics: How will it evolve?
    • Grabowski HG, Cockburn I, Long G. The market for follow-on biologics: how will it evolve? Health Aff 2006; 25: 1291-1301
    • (2006) Health Aff , vol.25 , pp. 1291-1301
    • Grabowski, H.G.1    Cockburn, I.2    Long, G.3
  • 18
    • 33749318580 scopus 로고    scopus 로고
    • Patents and new product development in the pharmaceutical and biotechnology industries
    • Grabowski HG. Patents and new product development in the pharmaceutical and biotechnology industries. The Georgetown Public Policy Review 2003; 8: 7-24
    • (2003) The Georgetown Public Policy Review , vol.8 , pp. 7-24
    • Grabowski, H.G.1
  • 20
    • 33746169811 scopus 로고    scopus 로고
    • Biosimilars: How similar or dissimilar are they?
    • Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology 2006; 11: 341-346
    • (2006) Nephrology , vol.11 , pp. 341-346
    • Roger, S.D.1
  • 21
    • 32944459736 scopus 로고    scopus 로고
    • Factors influencing the immunogenicity of therapeutic proteins
    • Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant 2005; 20 Suppl. 6: vi3-9
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 6
    • Schellekens, H.1
  • 22
    • 52049105653 scopus 로고    scopus 로고
    • Biosimilars: It's not simple as cost alone
    • Roger SD, Goldsmith D. Biosimilars: it's not simple as cost alone. J Clin Pharm Ther 2008; 33: 459-464
    • (2008) J Clin Pharm Ther , vol.33 , pp. 459-464
    • Roger, S.D.1    Goldsmith, D.2
  • 23
    • 33947710801 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins. Part 1: Impact of product handling
    • DOI 10.1016/j.biotechadv.2007.01.005, PII S0734975007000225
    • Sharma B. Immunogenicity of therapeutic proteins. Part 1: impact of product handling. Biotechnol Adv 2007; 25: 310-317 (Pubitemid 46498672)
    • (2007) Biotechnology Advances , vol.25 , Issue.3 , pp. 310-317
    • Sharma, B.1
  • 25
    • 84926044611 scopus 로고    scopus 로고
    • Committee for medicinal product for human use
    • EMEA, (ultimo accesso: 25 giugno 2009)
    • EMEA. Committee for Medicinal Product for Human Use. Guideline on similar biological medicinal product, 2005 (ultimo accesso: 25 giugno 2009)
    • (2005) Guideline on Similar Biological Medicinal Product
  • 28
    • 84867210570 scopus 로고    scopus 로고
    • Approfondimento su: Farmaci biotecnologici e biosimilari
    • Donnarumma E. Approfondimento su: farmaci biotecnologici e biosimilari. BIF 2008; 15
    • (2008) BIF , vol.15
    • Donnarumma, E.1
  • 29
    • 77953860403 scopus 로고    scopus 로고
    • Prescribing advice needed for new biosimilar biological drugs
    • 19 novembre 2007
    • Duerden M. Prescribing advice needed for new biosimilar biological drugs. Prescriber 2007; 19 novembre 2007, pagine 1-2
    • (2007) Prescriber , pp. 1-2
    • Duerden, M.1
  • 30
    • 77953826316 scopus 로고    scopus 로고
    • (Parere del) Consiglio di Stato, Sezione Prima, 20 giugno 2007: Regione Molise. Quesito sull'applicazione dell'equivalenza terapeutica tra farmaci, nel caso di acquisto di medicinali da parte di pubblici soggetti tramite gara
    • (Parere del) Consiglio di Stato, Sezione Prima, 20 giugno 2007: Regione Molise. Quesito sull'applicazione dell'equivalenza terapeutica tra farmaci, nel caso di acquisto di medicinali da parte di pubblici soggetti tramite gara
  • 31
    • 77953862911 scopus 로고    scopus 로고
    • Tribunale Amministrativo Regionale per l'Emilia Romagna, Sentenza N. 00001/2009 del 2 gennaio
    • Tribunale Amministrativo Regionale per l'Emilia Romagna, Sezione Seconda, Sentenza N. 00001/2009 del 2 gennaio 2009
    • (2009) Sezione Seconda
  • 33
    • 77953815432 scopus 로고    scopus 로고
    • The markets for biosimilars: Evolution and policy options
    • October. London: OHE, 2008
    • Chauhan D, Towse A, Mestre-Ferrandiz J. The markets for biosimilars: evolution and policy options. OHE Briefing 45, October 2008. London: OHE, 2008
    • (2008) OHE Briefing , vol.45
    • Chauhan, D.1    Towse, A.2    Mestre-Ferrandiz, J.3
  • 36
    • 69449083908 scopus 로고    scopus 로고
    • Potential savings of biogenerics in the United States
    • Miller S, Houts J. Potential savings of biogenerics in the United States. Express Scripts 2007 (www.expressscripts.com )
    • (2007) Express Scripts
    • Miller, S.1    Houts, J.2
  • 37
    • 44449162466 scopus 로고    scopus 로고
    • Modeling federal cost savings from follow-on biologics
    • Ahlstrom A, King R, Brown R, et al. Modeling federal cost savings from follow-on biologics. Avalere 2007 (www.avalerehealth.net )
    • (2007) Avalere
    • Ahlstrom, A.1    King, R.2    Brown, R.3
  • 38
    • 44449151539 scopus 로고    scopus 로고
    • Follow-on biologics: Data exclusivity and the balance between innovation and competition
    • Grabowski HG. 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.G.1
  • 39
    • 77953845767 scopus 로고    scopus 로고
    • Congressional Budget Office, June 25, 2008. Biologics Price Competition and Innovation Act of 2007. Cost estimate for the bill as ordered reported by the Senate Committee on Health, Education, Labor, and Pensions on June 27, 2007
    • Congressional Budget Office, June 25, 2008. Biologics Price Competition and Innovation Act of 2007. Cost estimate for the bill as ordered reported by the Senate Committee on Health, Education, Labor, and Pensions on June 27, 2007 (doc9496/s1695.pdf)
  • 40
    • 77953843866 scopus 로고    scopus 로고
    • A perspective on the biogeneric opportunity
    • 3.3
    • Patel S. A perspective on the biogeneric opportunity. The S.A.M. Newsletter 2004; 3.3: 4-13
    • (2004) The S.A.M. Newsletter , pp. 4-13
    • Patel, S.1
  • 43
    • 77953865378 scopus 로고    scopus 로고
    • FDA regulation of follow-on biologics
    • Washington, DC: Congressional Research Service
    • Johnson JA. FDA regulation of follow-on biologics. CRS Report for Congress. Washington, DC: Congressional Research Service, 2009
    • (2009) CRS Report for Congress
    • Johnson, J.A.1
  • 44
    • 47349126691 scopus 로고    scopus 로고
    • Policy, clinical and regulatory considerations
    • Gottlieb S. Policy, clinical and regulatory considerations. Am J Health Syst Pharm 2008; 65 Suppl. 6: S2-8
    • (2008) Am J Health Syst Pharm , vol.6
    • Gottlieb, S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.