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 "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 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 Melanoma skin cancer Arthritis Yet only 27 years later http://en.wikipedia.org/wiki/File:Da_Vinci_Vitruve_Luc_Viatour.jpg

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 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 Campath-H1 vs interferon http://users.ox.ac.uk/~path0116/tig/new1/mstrialfig.jpg

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

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 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”

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

We know - there is a cost to cancer cancer has the most devastating economic impact of any cause of death in the world. Cancer causes the highest economic loss of all of the 15 leading causes of death worldwide 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. Cancer is the most important disease for the world – with more impact than HIV, Malaria and Tuberculosis combined 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

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 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 Vaccines Immunostimulants Gene therapy Supportive care Novel approaches Hormonals Cytotoxics

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

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 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 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 Cancer treatment spending, in billions $72.1 Cancer is a key driver for increasing costs US$ $27.5 $13.1 $1.3