The biosimilars landscape

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The biosimilars landscape

Biosimilares/Investigación | Posted 23/09/2011 0 Post your comment

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.

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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.