There is obviously a market for biosimilars. This is driven by the cost savings to be made by payers and patients alike. By 2015, IMS Health (IMS) expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals. They expect new biosimilars to enter the US market by 2014 and European markets to have additional biosimilar molecules introduced during this period [1].
Biosimilars have been on the market since 2006 and are already present in many countries worldwide, see Table 1 [2].
Table 1: Biosimiars market entry onto multiple countries
| Country
|
HGH
|
EPO
|
G-CSF
|
| Europe (big 5)
|
|
|
|
| France
|
Q2 2007
|
Q1 2009
|
Q1 2009
|
| Germany
|
Q1 2007
|
Q1 2009
|
Q4 2008
|
| Italy
|
Q2 2006
|
Q4 2007
|
Q2 2009
|
| Spain
|
Q3 2007
|
Q1 2009
|
Q1 2009
|
| UK
|
Q2 2007
|
Q1 2009
|
Q4 2008
|
| Europe (rest)
|
|
|
|
| Austria
|
Q2 2009
|
Q3 2008
|
Q1 2009
|
| Belgium
|
Q2 2009
|
|
|
| Bulgaria
|
|
|
Q4 2009
|
| Denmark
|
|
Q1 2010
|
Q1 2009
|
| Finland
|
Q1 2008
|
Q3 2008
|
Q3 2009
|
| Greece
|
|
Q1 2009
|
Q2 2009
|
| Hungary
|
|
Q1 2009
|
Q1 2009
|
| Ireland
|
|
Q3 2008
|
Q4 2009
|
| Latvia
|
Q2 2009
|
|
Q1 2009
|
| Lithuania
|
|
Q1 2010
|
Q1 2009
|
| Netherlands
|
Q3 2009
|
Q4 2009
|
Q2 2009
|
| Norway
|
|
Q4 2008
|
Q1 2009
|
| Poland
|
Q2 2009
|
Q3 2009
|
Q3 2009
|
| Romania
|
Q3 2008
|
Q3 2009
|
Q2 2009
|
| Slovakia
|
|
|
Q2 2009
|
| Slovenia
|
Q4 2009
|
Q1 2009
|
Q4 2009
|
| Sweden
|
Q2 2008
|
Q2 2008
|
Q2 2009
|
| Rest of the world
|
|
|
|
| Australia
|
Q1 2010
|
|
Q1 2010
|
| Canada
|
Q3 2009
|
|
|
| Japan
|
Q3 2009
|
|
|
| US
|
Q1 2007
|
|
|
EPO: erythropoietin; G-CSF: granulocyte colony-stimulating factor; HGH: human growth hormone
Source: IMS Health
The first biosimilars approved were human growth hormone, followed by erythropoietin (EPO) and granulocyte colony-stimulating factor (G-CSF).
Global sales of biosimilars have more than doubled each year since 2007, and had reached more than US$234 million in 2010, see Figure 1. EPOs take the major share of the market with sales of US$93 million, followed by G-CSF (US$75 million) and human growth hormone (US$67 million). Despite the dominance of EPOs, Sandoz’s Omnitrope—a human growth hormone—is still the largest selling biosimilar, with global sales in 2010 of US$66 million.
Figure 1: Global biosimilar sales of EPO, G-CSF and HGH
EPOs: erythropoietins; G-CSF: granulocyte colony-stimulating factor; HGH: human growth hormone
Source: IMS Health
The biosimilars market is clearly experiencing rapid growth and looks set to reach IMS’s predictions exceeding US$2 billion annually by 2015.
Related articles
The market for global and European biosimilars
Biosimilars and the pharmaceutical industry
Biobetters rather than biosimilars
References
1. GaBI Online - Generics and Biosimilars Initiative. Generics and biosimilars to drive down drug spending [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 23]. Available from: www.gabionline.net/Pharma-News/Generics-and-biosimilars-to-drive-down-drug-spending
2. Sheppard A. Biological/Biotechnological and Biosimilars market: the global outlook. 9th EGA International Symposium on Biosimilar Medicines; 2011 Apr 14; London, UK.
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