Economic Analysis of Availability of Follow-on Protein Products. References

07/27/2009

  • [1]Grabowski H, Ridley D, Schulman K. Entry and competition in generic biologicals. Manag Decision Econ 2007; 28:439-51.
  • [2]Reiffen D, Ward M. Generic drug industry dynamics. Rev Econ Stat 2005;87(10):37-49.
  • [3]Saha A, Grabowski H, Birnbaum H, et al. Generic competition in the U.S. pharmaceutical industry. Int J Econ Bus 2006;13:15-38.
  • [4]Morton SF. Entry decisions in the generic pharmaceutical industry. RAND J Econ 1999;30(3):421-40.
  • [5]Grabowski H, Vernon J. Brand loyalty, entry, and price competition in pharmaceuticals after the 1984 Drug Act. J Law Econ 1992;35:331-50.
  • [6]Grabowski H, Cockburn I, Long G. The market for follow-on biologics: how will it evolve? Health Aff 2006; 25(5):1291-301.
  • [7]Guidance for industry: Applications covered by section 505(b)(2) – Draft guidance. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 1999. Accessed April 24, 2009 at http://www.fda.gov/CDER/GUIDANCE/2853dft.pdf.
  • [8]Dudzinzki DM, Kesselheim AS. Scientific and legal viability of follow-on protein drugs. N Engl J Med 2008; 528(8):843-49.
  • [9]Woodcock J, Griffin J, Behrman R, et al. The FDA’s assessment of follow-on protein products: a historical perspective. Nat Rev: Drug Disc 2007;6:437-42.
  • [10]Ibid.
  • [11]The Future of Biosimilars: Key Opportunities and Emerging Therapies. London, UK : Reuters Business Insights, 2007.
  • [12]Dudzinzki 2008.
  • [13]Woodcock 2007.
  • [14]Beers DO, Tsang L. US rules on biosimilars – what has changed? PLC Cross-border Life Sciences Handbook 2006/07.
  • [15]Woodcock 2007.
  • [16]European Medicines Agency. Human Medicines - EMEA Presubmission Guidance. What is the period of protection for my medicinal product? 1995-2007 EMEA. Accessed at: http://www.emea.europa.eu/htms/human/presub/q35.htm.
  • [17]Croft A. Biosimilars: a viable market? Epsicom. March 2007. Accessed at: http://www.espicom.com/web.nsf/structure/Brochures01/$File/biosim06bro.pdf.
  • [18]Top 20 biologics. Barcelona, Spain : La Merie Business Intelligence, 2007. Accessed November 16, 2007. http://www.pipelinereview.com/free-downloads/Top20Biologics2006.pdf.
  • [19]Omnitrope® Human Growth Hormone (HGH). Ingenix. Health Technology Pipeline. 3rd Quarter 2007.
  • [20]Personal communication, Bengt Jönsson, November 29, 2007.
  • [21]Zuhn D. Three new biosimilars pass EMEA test. Patent Docs: Biotech & Pharma Patent Law and News Blog, 2007. http://www.patentdocs.net/patentdocs/2007/07/three-new-biosi.html.
  • [22]Press release: Meeting highlights from the Committee for Medicinal Products for Human Use. European Medicines Agency: London, England . Accessed June 12, 2008. http://www.emea.europa.eu/pdfs/human/press/pr/47920007en.pdf.
  • 23]Top 20 biologics 2007.
  • [24]EPARs for authorised medicinal products for human use: Biograstim. London, England : European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/biograstim/biograstim.htm.
  • [25]EPARs for authorised medicinal products for human use: Filgrastim Ratiopharm. London, England : European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/filgrastimratiopharm/filgrastimratiopharm.htm.
  • [26]EPARs for authorised medicinal products for human use: Ratiograstim. London, England : European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/ratiograstim/ratiograstim.htm.
  • [27]EPARs for authorised medicinal products for human use: Tevagrastim. London, England : European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/tevagrastim/tevagrastim.htm.
  • [28]EPARs for authorised medicinal products for human use: Filgrastim Hexal. London, England : European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/filgrastimhexal/filgrastimhexal.htm.
  • [29]EPARs for authorised medicinal products for human use: Zarzio. London, England : European Medicines Agency, 2008. Accessed May 10, 2009 at http://www.emea.europa.eu/humandocs/Humans/EPAR/zarzio/zarzio.htm.
  • [30]Top 20 biologics 2007.
  • [31]S.726 Promoting Innovation and Access to Life-Saving Medicine Act. Washington, DC: 111th Congress of the United States of America , Senate, 2009. Accessed May 10, 2009 at http://www.govtrack.us/congress/bill.xpd?tab=summary&bill=s111-726.
  • [32]S.623 Access to Life-Saving Medicine Act. Washington, DC: 110th Congress of the United States of America , Senate, 2008. Accessed June 18, 2008 at http://www.govtrack.us/congress/bill.xpd?tab=summary&bill=s110-623.
  • [33]H.R. 1548: Pathway for Biosimilars Act. 111th Congress of the United States , House of Representatives, 2009. Accessed May 10, 2009 at http://www.govtrack.us/congress/bill.xpd?tab=summary&bill=h110-5629.
  • [34]H.R. 5629: Pathway for Biosimilars Act. 110th Congress of the United States , House of Representatives, 2008. Accessed June 16, 2008 at http://www.govtrack.us/congress/bill.xpd?tab=summary&bill=h110-5629.
  • [35]H.R. 1956: Patient Protection and Innovative Biologic Medicines Act of 2007. 110th Congress of the United States , House of Representatives, 2007. Accessed June 16, 2008 at http://www.govtrack.us/congress/bill.xpd?bill=h110-1956&tab=summary.
  • [36] S. 1505: Affordable Biologics for Consumers Act. 110th Congress of the United States , House of Representatives, 2007. Accessed June 16, 2008 at http://www.govtrack.us/congress/bill.xpd?tab=summary&bill=s110-1505.
  • [37]S. 1695: Biologics Price Competition and Innovation Act of 2007. 110th Congress of the United States , House of Representatives, 2007. Accessed June 16, 2008 at http://www.govtrack.us/congress/bill.xpd?tab=summary&bill=s110-1695.
  • [38]Schacht WH, Thomas JR. Follow-on biologics: Intellectual property and innovation issues. Congressional Research Service: Washington, DC. April 1, 2009.
  • [39]Bill would allow FDA approval of generics. Washington, DC: Congressional Quarterly Health Beat, March 11, 2009.
  • [40]Congressional Quarterly Health Beat, March 11,2009.
  • [41]Kelleher KR. FDA Approval of Generic Biologics: Finding a Regulatory Pathway, 14 Mich. Telecomm. Tech. L. Rev. 245 (2007), available at http://www.mttlr.org/volfourteen/kelleher.pdf.
  • [42]Ahlstrom A, King A, et al. Modeling Federal Cost Savings from Follow-on Biologics. Washington, DC: Avalere Health LLC, April 2007.
  • [43]Potential Savings That Might Be Realized by The Medicare Program by Enactment of Legislation Such As The Access to Life-Saving Medicine Act (H.R. 6257/S. 4016) That Establishes a New cLBA Pathway for Follow-on Biologics. Washington, DC: Engel & Novitt LLP, January 2007.
  • [44]Miller S, Houts J. Potential Savings of Biogenerics in the United States . Express Scripts, February 2007.
  • [45]Ahlstrom A, et al. 2007.
  • [46]Engel & Novitt LLP 2007.
  • [47]Miller S 2007.
  • [48]Jaspen B. Lower-cost drugs predicted under the Obama administration. Baltimore Sun Tribune: Baltimore, MD. November 30, 2008. Accessed 29 December 2008. http://www.baltimoresun.com/topic/chi-sun-obama-health-care-nov30,0,1904232.story.
  • [49]Top 20 biologics 2007.
  • [50]The future of biosimilars 2007.
  • [51]Ibid.
  • [52] Pisani J, Bonduelle Y. Opportunities and barriers in the biosimilar market: evolution or revolution for generics companies? PriceWaterhouseCoopers LLP, 2007.
  • [53]Interview with Bengt Jönsson. November 29, 2007.
  • 54]Interview with Paul Aebersold. November 29, 2007.
  • [55]Interview with FDA Staff: Steven Kozlowski, Christopher Joneckis, Keith Webber and Terrie Crescenzi. December 4, 2007.
  • [56]Ibid.
  • [57]Grabowski 2007.
  • [58]Reiffen 2005.
  • [59]Saha 2006.
  • [60]Morton 1999.
  • [61]Grabowski 1992.
  • [62]Grabowski H 2007
  • [63]Reiffen D 2005.
  • [64]Saha A 2006.
  • [65]Bhattacharya J, Vogt W. A simple model of pharmaceutical price dynamics. J Law Econ 2003;46:599-626.
  • [66]Morton 1999.
  • [67]Grabowski 1992.
  • [68]Bresnahan TF, Reiss PC. Entry and competition in concentrated markets. J Polit Econ 1991;99(5):977-1009.
  • [69]Gaynor M, Li J, Vogt W. Substitution, spending offsets, and prescription drug benefit design. Forum Health Econ Pol 2007;10(2):Article 4.
  • [70]Joyce GF, Escarce JJ, Solomon MD, Goldman DP. Employer drug benefit plans and spending on prescription drugs. JAMA 2002;288(14):1733–9.
  • [71]Gaynor, Li, and Vogt (2007) also estimate that the cost impact of changes in pharmaceutical utilization following changes in cost is partially offset through changes in the demand for other types of health care. We draw from that point in this model.
  • [72]Top 20 biologics 2007.
  • [73]Miller 2007.
  • [74]Zuhn 2007.
  • [75]The future of biosimilars 2007.
  • [76]Amgen announces update to US prescribing information for Aranesp ® and EPOGEN ®: New boxed warning applies to oncology and nephrology indications for the class of approved ESAs. Thousand Oaks, CA: Amgen, 2007.
  • [77]Rader RA. Biopharmaceutical products in the US and European markets. BioPlan Associates, Inc., 2007.
  • [78]Pollack A. Patent held by Genentech is revoked by government. The New York Times, February 22, 2007. Accessed January 18, 2008. http://www.nytimes.com/2007/02/22/business/22patent.html?r=1&oref=slogin.
  • [79]Interview with Paul Aebersold. November 29, 2007.
  • [80]What is hemophilia? National Heart, Lung, and Blood Institute, 2007. http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophiliawhat.html.
  • [81]Pisani J 2007.
  • [82]Searcy C. How advanced drug delivery technologies can help manage product life cycles throughout pharmaceutical development. Montville, NJ: Drug Delivery Technologies. Accessed January 18, 2008. http://www.drugdeliverytech.com/cgi-bin/articles.cgi?idArticle=206.
  • [83]Top 20 biologics 2007.
  • [84]Miller 2007.
  • [85]Riley 2008.
  • [86]Top 20 biologics 2007.
  • [87]PRCA Update. Thousand Oaks, CA: Amgen, Inc., 2007. Accessed November 30, 2007 at http://www.amgen.com/patients/prca.html.
  • [88]Amgen wins arbitration and awarded $150 million against Johnson & Johnson. Thousand Oaks, CA: Amgen, Inc., 2002. Accessed January 6, 2008 at http://www.immunex.com/media/mediaprdetail.jsp?year=2002&releaseID=515229.
  • [89]Procrit® (epoetin alfa). Full prescribing information. Thousand Oaks, CA: Amgen, Inc.; Raritan, NJ: Ortho Biotech Products, L.P., 2007. Accessed December 13, 2007. http://www.procrit.com/procrit/shared/OBI/PI/ProcritBooklet.pdf#page=1.
  • [90]Epogen® (epoetin alfa). Full prescribing information. Thousand Oaks, CA: Amgen, Inc., 2007. Accessed November 30, 2007. http://www.epogen.com/pdf/epogenpi.pdf.
  • [91]Interview with Bengt Jönsson. November 29, 2007.
  • [92]Zuhn 2007.
  • [93]Rader 2007.
  • [94]Miller 2007.
  • [95]Ledford H. Biotechs go generic: The same but different. Nature 2007;449:274.
  • [96]Pollack 2007.
  • [97]Top 20 biologics 2007.
  • [98]About Rituxan (rituximab). Biogen Idec & Genentech, 2007. Accessed November 16, 2007 at http://www.rituxan.com/lymphoma/RituxanRoleInNHL.jsp.
  • [99]Top 20 biologics 2007.
  • [100]Remicade (infliximab) - treating your condition. Centocor, Inc., 2007. Accessed November 16, 2007 at http://www.remicade.com/remicade/global/treatingyourcondition.html.
  • [101]Lanthier M, Behrman R, Nardinelli C. Economic issues with follow-on protein products. Nature Reviews Drug Discovery, 2008: e-pub 25 July, 2008.
  • [102]The future of biosimilars 2007.
  • [103]Top 20 biologics 2007.
  • [104]Riley 2008.
  • [105]Ibid.
  • [106]Top 20 biologics 2007.
  • [107]Riley 2008.
  • [108]Top 20 biologics 2007.
  • [109]Ibid.
  • [110]Miller 2007.
  • [111]Riley 2008.
  • [112]Top 20 biologics 2007.
  • [113]Ibid.
  • [114]The future of biosimilars 2007.
  • [115]Riley 2008.
  • [116]Pisani 2007.
  • [117]Top 20 biologics 2007.
  • [118]Pisani 2007.
  • [119]The future of biosimilars 2007.
  • [120]Riley 2008.
  • [121]Top 20 biologics 2007.
  • [122]Searcy 2007.
  • [123]Top 20 biologics, 2007.
  • [124]Riley 2008.
  • [125]Top 20 biologics 2007.
  • [126]Searcy 2007.
  • [127]Medco. 2007 Drug Trend Report. Accessed April 13, 2009 at: http://medco.mediaroom.com/index.php?s=64&cat=5; Nadeau et al. Cowen and Company Biotechnology Industry Outlook: Putting “Stock” Into Partnerships. 2008.
  • [128]Producer Price Index for pharmaceutical preparation manufacturing. Accessed April 13, 2009 at: http://www.bls.gov/ppi/home.htm.
  • [129]2007 Annual report for Genentech.
  • [130]2007 Annual report for Eli Lilly.
  • [131]Although the EMEA granted five separate applications for biosimilars to EPO products (three for epoetin alphas and two for epoetin zetas), all three epoetin alpha applications were for the same compound, manufactured by a single company and citing the same sequence of clinical trials. A similar situation occurred with the two epoetin zeta applications. EPARs for authorised medicinal products for human use. London, England : European Medicines Agency, 2008. Accessed May 10, 2009 at: http://www.emea.europa.eu/htms/human/epar/eparintro.htm.
  • [132]Neither Amgen nor Johnson & Johnson report sales figures for the EU alone; instead product revenue is reported for the US and non-US countries. Our estimate of sales figures for the EU is based on the non-US sales figures.
  • [133]Under the latter calibration, the correct interpretation of the calibrated parameter would be the relative net, discounted expected fixed cost of entering each of the global markets (sequentially) for a biologic drug compared with a small-molecule drug.
  • [134]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. London, England : European Medicines Agency 2006. Accessed April 7, 2009 at: http://www.emea.europa.eu/pdfs/human/biosimilar/9452805en.pdf.
  • [135]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 Recombinant Erythropoietins. London, England : European Medicines Agency 2006. Accessed April 7, 2009 at. http://www.emea.europa.eu/pdfs/human/biosimilar/9452605en.pdf.
  • [136]Guideline on Similar Medicinal Products Containing Recombinant Interferon Alpha: Draft. London, England : European Medicines Agency 2007. Accessed April 7, 2009 at http://www.emea.europa.eu/pdfs/human/biosimilar/10204606en.pdf.
  • [137]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 Recombinant Granulocyte-Colony Stimulating Factor. London, England : European Medicines Agency 2006. Accessed April 7, 2009 at :http://www.emea.europa.eu/pdfs/human/biosimilar/3132905en.pdf.
  • [138] Assuming that fixed costs of entry for the small molecule generic market are ~$2.5mn, this would imply a range of fixed costs of entry in the biologic market between $21.8mn and $40.5mn. Estimates of fixed costs of entry in the small molecule market of $ 5mn imply FoPP entrant costs of $43.5-$81mn. Grabowski, Cockburn and Long (2006) quote presentations by T. Oldham at the 2005 IBC conference in Brussels and E. Schafer at the 2005 “Institute for International Research in Follow-On Biologics Forum” in Washington, DC, that reported estimated FoPP entry costs of $10-40mn.
  • [139]Goldman D, Joyce G, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA 2007;298(1):61-9.
  • [140]Reiffen 2005.
  • [141]The proxy for HMO coverage among public payers is HMO share (65%) in Medicare Advantage plans, which cover 19% of Medicare beneficiaries (Kaiser Family Foundation “Medicare Advantage in 2008”). Accessed April 7, 2009 at http://www.kff.org/medicare/upload/7775.pdf.
  • [142]Employer Health Benefits 2007 Annual Survey. The Kaiser Family Foundation and Health Research and Educational Trust, 2007. Accessed April 7, 2009 at http://www.kff.org/insurance/7672/upload/76723.pdf.
  • [143]Private and public payer shares estimated based on combination of epidemiologic data, and analysis of proprietary claims data.
  • [144]Goldman 2007
  • [145]Congressional Budget Office. Cost Estimate: S. 1695 Biologics Price Competition and Innovation Act of 2007. June 25, 2008.
  • [146]Miller 2007.
  • [147]Engel & Novitt LLP 2007.
  • [148]Ahlstrom 2007.
  • [149]Schacht 2009.

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