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Biosimilars - Can we do without them?  Dr Paul Cornes, Consultant Oncologist,

Biosimilars - Can we do without them?  Dr Paul Cornes, Consultant Oncologist, Bristol Haematology & Oncology Centre paul.cornes@yahoo.co.uk. Comparative Outcomes Group. Pharmaceutical medicine moves fast!. 1984 Nobel Prize for Medicine.

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Biosimilars - Can we do without them?  Dr Paul Cornes, Consultant Oncologist,

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  1. Biosimilars - Can we do without them?  Dr Paul Cornes, Consultant Oncologist, Bristol Haematology & Oncology Centre paul.cornes@yahoo.co.uk Comparative Outcomes Group

  2. Pharmaceutical medicine moves fast! 1984 Nobel Prize for Medicine "for the discovery of the principle for production of monoclonal antibodies". awarded jointly to Niels K. Jerne, Georges J.F. Köhler and César Milstein Yet only 27 years later

  3. We have developed a whole range of new treatments - 1984 to 2012 Monoclonal antibody therapy Head and Neck Cancer Macular Degeneration Multiple sclerosis Breast Cancer Asthma Bowel Cancer Heart disease Leukaemia Transplant rejection Lymphoma Inflammatory bowel disease Ovary cancer Secondary bone cancer Psoriasis Arthritis Melanoma skin cancer Yet only 27 years later http://en.wikipedia.org/wiki/File:Da_Vinci_Vitruve_Luc_Viatour.jpg

  4. Monoclonals in Cancer - Lymphoma • Rituximab • Halves Lymphoma Relapse • Prima Trial reviewed at http://www.medscape.com/viewarticle/722470 http://www.jnccn.org/content/8/Suppl_6/S-1/F3.large.jpg

  5. Monoclonals in Breast Cancer • Trastuzumab • Halves the chance of relapse • Reduces death by 33% Romond EH, et al. NEJM. 2005;353:1673-1684

  6. 71% reduction in disability in Multiple sclerosis Campath-H1 vs interferon http://users.ox.ac.uk/~path0116/tig/new1/mstrialfig.jpg

  7. Controlling type 1 diabetes Anti-CD3 vs placebo http://users.ox.ac.uk/~path0116/tig/new1/t1dtrial.jpg

  8. Controlling Rheumatoid Arthritis Thermal imaging of hand and elbow joints before…… ..and after Mab therapy http://users.ox.ac.uk/~path0116/tig/new1/thefg.gif

  9. Controlling painful skin diseases – Efalizumab for psoriasis • Sylvia Marecki & Peter Kirkpatrick. Efalizumab. Nature Reviews Drug Discovery 2004;3:473-474 • http://www.epgpatientdirect.org/send_article.cfm/page/355/title/Biologicals

  10. All demonstrations of the power of “Biologic or Targeted therapy”

  11. I am very fortunate to work with international colleagues Comparative Outcomes Group

  12. We know - there is a cost to cancer Cancer causes the highest economic loss of all of the 15 leading causes of death worldwide cancer has the most devastating economic impact of any cause of death in the world. WHO: Cancer world's top killer since 2010 16.7 percent of all 'healthy' years lost in the European Union The total economic impact of premature death and disability from cancer worldwide was $895 billion in 2008. 83 million years of “healthy life” lost due to death and disability from cancer in 2008. • www.usatoday.com/news/health/2008-12-09-cancer_N.htm • http://www.cancer.org/acs/groups/content/@internationalaffairs/documents/document/acspc-026203.pdf

  13. We know - there is a cost to cancer care …but “cost” may be the wrong word to use – try “investment” instead “Think about health spending as not consumption but investment” David E. Bloom, professor of economics and demography at Harvard http://www.bloomberg.com/news/2011-06-20/global-rise-in-cancer-cost-300-billion-in-2010-harvard-economist-says.html File:David E. Bloom at the World Economic Forum Summit on the Global Agenda 2008.jpg

  14. Vaccines Immunostimulants Gene therapy Supportive care Novel approaches Hormonals Cytotoxics Payback on our “investment” is plain to see - Good news for cancer treatment • Cancer death rates are falling • Jemal A, Ward E, Thun M (2010). Declining death rates reflect progress against cancer. PLoS ONE 5(3): e9584. doi:10.1371/journal.pone.0009584 • Novel approaches dominate drug development • Timbs O, Cancer World, 2004; Sept-Oct p.12

  15. The costly war on cancer. The Economist. 2011 May 26. http://www.economist.com/node/18743951 Good news for cancer treatment Drugs in development, 2010 900 drugs in development are for cancer

  16. But it is not all good news – Bad news for cancer treatment • There will be more cancer to treat • World population growth and ageing imply a progressive increase in the cancer burden • 15 million new cases,10 million new deaths are expected in 2020,even if current rates remain unchanged • D Maxwell Parkin. Global cancer statistics in the year 2000. Lancet. 2001;2(9) 01 September • New cancer cases will likely increase to 27 million annually by 2030, with deaths hitting 17 million • http://www.usatoday.com/news/health/2008-12-09-cancer_N.htm

  17. Bad news for cancer treatment • Innovative drug development is slow and expensive • From 5000 - 10000 compounds in pre-clinical trials: • only 0.1% reach clinical trial stage • of these, only 10-20% are finally approved • It takes 15 years from the target discovery to the market at 800 million $/drug • Adams CP et al: Estimating the cost of new drug development: Is it really 802 million dollars? Health Aff (Millwood) 2006;25:420-428

  18. ASCO 2009 Meeting emphasis: individualised care and cost-effectiveness USA Medical insurance costs are rising faster than earnings and general inflation Medical care is becoming unaffordable Ward E. CA Cancer J, 2008;58:9-31

  19. Cost of USA cancer care 1963 to 2004 Cancer treatment spending, in billions $72.1 Cancer is a key driver for increasing costs US$ $27.5 $13.1 $1.3

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