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Biosimilars - Can we do without them?  Dr Paul Cornes, Consultant Oncologist, Bristol Haematology & Oncology Centre [email protected] 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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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

[email protected]

Comparative Outcomes Group


Pharmaceutical medicine moves fast

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


We have developed a whole range of new treatments 1984 to 2012 monoclonal antibody therapy

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


Monoclonals in cancer lymphoma

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


Monoclonals in breast cancer

Monoclonals in Breast Cancer

  • Trastuzumab

    • Halves the chance of relapse

    • Reduces death by 33%

Romond EH, et al. NEJM. 2005;353:1673-1684


71 reduction in disability in multiple sclerosis

71% reduction in disability in Multiple sclerosis

Campath-H1 vs interferon

http://users.ox.ac.uk/~path0116/tig/new1/mstrialfig.jpg


Controlling type 1 diabetes

Controlling type 1 diabetes

Anti-CD3 vs placebo

http://users.ox.ac.uk/~path0116/tig/new1/t1dtrial.jpg


Controlling rheumatoid arthritis

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


Controlling painful skin diseases efalizumab for psoriasis

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


All demonstrations of the power of biologic or targeted therapy

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


I am very fortunate to work with international colleagues

I am very fortunate to work with international colleagues

Comparative Outcomes Group


We know there is a cost to cancer

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:[email protected]/documents/document/acspc-026203.pdf


  • We know there is a cost to cancer care

    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


    Payback on our investment is plain to see good news for cancer treatment

    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


    Good news for cancer treatment

    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


    But it is not all good news bad news for cancer treatment

    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


    Bad news for cancer treatment

    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


    Asco 2009 meeting emphasis individualised care and cost effectiveness

    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


    Cost of usa cancer care 1963 to 2004

    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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