Biosimilars - Can we do without them?

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

paul.cornes@yahoo.co.uk

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

1984 Nobel Prize for Medicine

awarded jointly to Niels K. Jerne, Georges J.F.

Köhler and César Milstein

awarded jointly to Niels K. Jerne, Georges J.F.

Köhler and César Milstein

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

"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

http://en.wikipedia.org/wiki/File:Da_Vinci_Vitruve_Luc_Viatour.jpg

Breast Cancer

Head and Neck Cancer

Bowel Cancer

Leukaemia

Lymphoma

Ovary cancer

Secondary bone cancer

Melanoma skin cancer

Macular Degeneration

Multiple sclerosis

Asthma

Heart disease

Transplant rejection

Inflammatory bowel disease

Psoriasis

Arthritis

Yet only 27 years later

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

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

Campath-H1 vs interferon

Controlling type 1 diabetes

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

Anti-CD3 vs placebo

Controlling Rheumatoid Arthritis

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

Thermal imaging of hand and elbow joints before……

..and after Mab therapy

Controlling painful skin diseases – Efalizumab for psoriasis

1. Sylvia Marecki & Peter Kirkpatrick. Efalizumab. Nature Reviews Drug Discovery 2004;3:473-474 2. 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

83 million years of “healthy life” lost due to death and disability from cancer in 2008.

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

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.

www.usatoday.com/news/health/2008-12-09-cancer_N.htmhttp://www.cancer.org/acs/groups/content/@internationalaffairs/documents/document/acspc-026203.pdf

WHO: Cancer world's top killer since 2010

We know - there is a cost to cancer care

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

“Think about health spending as not consumption but investment”

David E. Bloom, professor of economics and demography at Harvard

…but “cost” may be the wrong word to use – try “investment” instead

Payback on our “investment” is plain to see - Good news for cancer

treatment

Vaccines

Immunostimulants

Gene therapy

Supportive care

Novel approaches

Hormonals

Cytotoxics

• 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

Drugs in development, 2010

Drugs in development, 2010

900 drugs in development are for cancer

900 drugs in development are for cancer

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-

effectivenessUSA Medical insurance costs are rising faster than earnings and general inflation

Ward E. CA Cancer J, 2008;58:9-31

Medical care is becoming

unaffordable

Cost of USA cancer care 1963 to 2004

Cancer treatment spending, in billions

US$

$1.3$13.1

$27.5

$72.1

Cancer is a key driver for increasing

costs