Transcript Part 1

Biosimilars - Can we do without them?

Dr Paul Cornes, Consultant Oncologist, Bristol Haematology & Oncology Centre

Comparative Outcomes Group

[email protected]

Pharmaceutical medicine moves fast!

1984 Nobel Prize for Medicine awarded jointly to Niels K. Jerne, Georges J.F. Köhler and César Milstein

"for the discovery of the principle for production of monoclonal antibodies".

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 Bowel Cancer Leukaemia Lymphoma Ovary cancer Secondary bone cancer Melanoma skin cancer Asthma Heart disease Transplant rejection Inflammatory bowel disease Psoriasis 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.c

om/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……

http://users.ox.ac.uk/~path0116/tig/new1/thefg.gif

..and after Mab therapy

Controlling painful skin diseases – Efalizumab for psoriasis 1.

2.

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 The total economic impact of premature death and disability from cancer worldwide was $895 billion in 2008.

16.7 percent of all 'healthy' years lost in the European Union 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

Vaccines

development –

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

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

ASCO 2009 Meeting emphasis: individualised care and cost-

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

US$ $1.3

Cancer is a key driver for increasing costs $13.1

$27.5