The market for global and European biosimilars

Biosimilars/Research | Posted 16/09/2011 post-comment0 Post your comment

Due to expiring patents for brand name products, cheaper generics are expected to grab market share [1]. This is not surprising due to the list of blockbuster drugs losing their patent protection in 2011 and 2012. These include the world’s best-selling drug, Lipitor (atorvastatin), which in 2010 had almost US$13 billion in worldwide sales, accounting for 15.8% of Pfizer’s total revenue [2].

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Biosimilars

But what is the market for biosimilars and can they expect to bring in revenues similar to the generics industry?

The answer appears to be yes. Three biological medicines are included in the top 10 worldwide sales, see Figure 1, while if we look at Europe alone seven biologicals make it into the top 10 in terms of sales, see Figure 2. Biologicals also have some of the fastest growth in terms of sales, both globally and in Europe. In 2010, growth in sales of biological medicines of 5.9–23.8% was recorded by IMS Health (IMS). One of the bestsellers in the biological class, the arthritis drug Enbrel (etanercept), will lose its patent protection in 2012, opening up more than US$6 billion in global sales to competition from biosimilars.

By 2015, 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 [3].

Figure 1: Top 10 best-selling medicines – global sales 2010

Brand name Generic name Sales US$ (million) % total sales % growth
Lipitor atorvastatin 12,989.6 1.7 -3.9
Plavix clopidogrel 8,886.2 1.1 -1.5
Seretide fluticasone/salmeterol 8,458.2 1.1 6.5
Nexium esomeprazole 8,387.5 1.1 3.2
Seroquel quetiapine 6,664.9 0.9 14.7
Crestor rosuvastatin 6,495.9 0.8 28.4
Enbrel* etanercept 6,085.1 0.8 5.9
Remicade* infliximab 5,932.5 0.8 10.8
Humira* adalimumab 5,748.1 0.7 21.8
Zyprexa olanzapine 5,645.1 0.7 7.7
TOTAL 75,293.1 9.6 6.7

*Biosimilars
Source: IMS Health

Figure 2: Top 10 best-selling medicines – European sales 2010

Brand name Generic name Sales US$ (million) % total sales % growth
Lipitor atorvastatin 2,822.6 1.2 -4.3
Humira* adalimumab 2,504.0 1.1 23.8
Seretide fluticasone/salmeterol 2,495.1 1.1 4.4
Enbrel* etanercept 2,161.8 0.9 8.7
Herceptin* trastuzumab 1,976.0 0.8 7.6
Avastin* bevacizumab 1,788.7 0.8 18.8
Lovenox enoxaparin sodium 1,764.1 0.8 9.3
Mabthera* rituximab 1,722.0 0.7 12.1
Glivec* imatinib 1,699.4 0.7 6.7
Remicade* infliximab 1,682.0 0.7 15.0
TOTAL 20,615.9 8.8 9.1

*Biosimilars
Source: IMS Health

The US on the other hand has only one biological medicine, Epogen (epoetin alfa), in its top 10 bestselling medicines and Japan none.

Related articles

The biosimilars landscape

Biosimilars and the pharmaceutical industry

References

1. Sheppard A. Biological/Biotechnological and Biosimilars market: the global outlook. 9th EGA International Symposium on Biosimilar Medicines; 2011 Apr 14; London, UK.

2. GaBI Online - Generics and Biosimilars Initiative. 2011’s biggest patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 09]. Available from: www.gabionline.net/Policies-Legislation/2011-s-biggest-patent-expiries

3. 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 09]. Available from: www.gabionline.net/Pharma-News/Generics-and-biosimilars-to-drive-down-drug-spending

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