Biosimilars - Can we do without them?

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Biosimilars - Can we do without them?  Dr
Paul Cornes, Consultant Oncologist, Bristol
Haematology Oncology Centre paul.cornes_at_ya
hoo.co.uk
Comparative Outcomes Group
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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
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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/FileDa_Vinci_Vitruve
_Luc_Viatour.jpg
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Monoclonals in Cancer - Lymphoma

• Rituximab
• Halves Lymphoma Relapse
• Prima Trial reviewed at http//www.medscape.com/vi
  ewarticle/722470

http//www.jnccn.org/content/8/Suppl_6/S-1/F3.larg
e.jpg
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Monoclonals in Breast Cancer

• Trastuzumab
• Halves the chance of relapse
• Reduces death by 33

Romond EH, et al. NEJM. 20053531673-1684
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71 reduction in disability in Multiple sclerosis
Campath-H1 vs interferon
http//users.ox.ac.uk/path0116/tig/new1/mstrialfi
g.jpg
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Controlling type 1 diabetes
Anti-CD3 vs placebo
http//users.ox.ac.uk/path0116/tig/new1/t1dtrial.
jpg
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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
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Controlling painful skin diseases Efalizumab
for psoriasis

1. Sylvia Marecki Peter Kirkpatrick. Efalizumab.
   Nature Reviews Drug Discovery 20043473-474
2. http//www.epgpatientdirect.org/send_article.cfm/p
   age/355/title/Biologicals

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All demonstrations of the power of Biologic or
Targeted therapy
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I am very fortunate to work with international
colleagues
Comparative Outcomes Group
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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.h
tm http//www.cancer.org/acs/groups/content/_at_inter
nationalaffairs/documents/document/acspc-026203.pd
f
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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-ri
se-in-cancer-cost-300-billion-in-2010-harvard-econ
omist-says.html FileDavid E. Bloom at the World
Economic Forum Summit on the Global Agenda
2008.jpg
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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. doi10.1371/journal.pone.0009584
• Novel approaches dominate drug development
• Timbs O, Cancer World, 2004 Sept-Oct p.12

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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

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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. 20012(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-can
  cer_N.htm

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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) 200625420-428

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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, 2008589-31
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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