With 90% of today’s biological medicines due to lose patent protection in the coming years, a wealth of targets is coming into range for biosimilars developers. Despite the fact that it costs much more, both in terms of money and time, to develop a biosimilar rather than a generic medicine, the potential returns for biosimilars are massive. Existing blockbuster biologicals achieve individual annual sales of US$5 billion or more and the biosimilars market is estimated to be worth at least US$10 billion by 2015 [2].

Patents on the twelve best-selling biological medicines, apart from for Enbrel, which has had its US patent extended [3], will expire by 2020 [4]. This means that sales of an estimated US$67 billion will be open to competition from biosimilars [5].

Just looking at the top five best-selling biological drugs, global sales of more than US$34 billion will be open to competition by the biosimilars industry, see Table 1. Key patent expiries include Abbott Laboratories’ Humira (adalimumab) and Amgen’s Enbrel (etanercept), although Enbrel’s patent in the US has been extended until 22 November 2028 [3].

Table 1: Top 5 best-selling biologicals

Source: Sheppard et al. [6]

Biotechnology has evolved at an unparalleled rate. The biologicals that are now being viewed as biosimilar targets were developed 15 or more years ago and, due to strict processing controls, are unlikely to have changed much in that time. But manufacturing and analytical techniques and technology have improved enormously, providing a potential opportunity.

If biosimilars are not required to use the same ‘old technology’ as the originator product, then the biosimilars of today could represent an improvement on the original, not just a similar product. For example, development of a biosimilar with reduced aggregation could solve problems with unwanted immunogenicity, which are associated with older products [7].

Editor’s comment
The current EMA regulatory pathway for biosimilars does not allow for such improvements, as this would mean that the biosimilar would produce different potency and dosing, which is not allowed under comparability requirements – an area the regulatory agencies need to consider in the future.

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Related articles

European uptake of biosimilars

Global uptake of biosimilars

Biosimilars: key players and global market trends

References

1.  European Biopharmaceutical Enterprises. What are biopharmaceuticals? [cited 2012 Oct 26]. Available from: www.ebe-biopharma.org/index.php?option=com_content&task=view&id=26&Itemid=102

2.  Reuters. Drugmakers bet on biosimilars, hurdles seen [cited 2012 Oct 26]. Available from: http://in.reuters.com/article/2010/09/29/idINIndia-51825420100929

3.  GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028

4.  GaBI Online - Generics and Biosimilars Initiative. US$54 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 26]. Available from: www.gabionline.net/Biosimilars/Research/US-54-billion-worth-of-biosimilar-patents-expiring-before-2020

5.  GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 26]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

6.  Sheppard A. Iervolino A. Biosimilars: about to leap. 10^th EGA International Symposium on Biosimilar Medicines. London. 19–20 April 2012.

7.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar comparability debate continues [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 26]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-comparability-debate-continues

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