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Opportunities for biosimilar development Posted 06/05/2011

Rising drug costs and limited healthcare budgets across the world, coupled with the fact that many biotechnology drugs will soon lose their patent protection, means that there is a huge opportunity for biosimilar manufacturers.

According to Dr Mark McCamish and Dr Gillian Woollett the limited access to high-quality biologicals due to the cost of treatment constitutes an unmet medical need in the US and other regions of the world [1].

Since the first approval of a biological product in 1986 in the US the biologicals market has bloomed. According to the authors, in 2009 worldwide sales of biologicals reached US$93 billion, with monoclonal antibodies (mAbs) making up the vast majority of this. It is not surprising then that approximately 30% of all pharmaceutical research and development consists of biologicals, with almost a third of that being on mAbs.

The authors also estimate that by 2016 ten of the top 20 selling drugs will be biologicals. This looks like being an underestimate with reports in 2010 stating that eight of the top 20 drugs are already biologicals.

The problem with these biologicals is the cost, especially as they are often used for chronic conditions, such as rheumatoid arthritis. Whereas a small molecule drug costs on average US$1 per day, with a generic costing just cents, a biological costs on average US$22 per day. This causes a big headache for healthcare systems, which are already stretched by budget cuts. Costs for treatment of rheumatoid arthritis with Humira (adalimumab) are estimated at US$50,000 per year.

However, pending patent expiry on many of these recombinant biologicals means that an estimated 40% of these biologicals will be open to competition by 2015 and by 2020 more than US$100 billion in biologicals sales will be off patent.

Therein lies the opportunity for high quality but cheaper biosimilars to enter the market, thus enabling patients to have continued access to these, often life-changing, therapies.

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Reference

1. McCamish M, Woollett G. Worldwide experience with biosimilar development. mAbs. 2011;3(2):209-17. doi:10.4161/mabs.3.2.15005

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