Psoriatic Arthritis treatment attracts attention for Biosimilar development

2nd February 2015

Category: Biosimilars

Tags: ,

By: Dr Daniel Galbraith, CSO,

Like waiting for a bus, there was no effective treatment for psoriatic arthritis then three came along. The literature has been awash with the new treatments; anti-TNF α drugs such as Enbrel and Humira. Janssens anti-IL-12/23 drug Stelara and now the new IL-17 blocker Secukinumab from Novartis. These drugs have clinically demonstrated to be effective at treating this condition in a remarkably short period. Despite this there has been a slow uptake by clinicians but this seems to be improving as the education about the benefits of these treatments improves. All of these drugs provide a relief of symptoms rather than a cure for the disease however the reduction in disability provided by these medications is remarkable.

The downside to extending the use of these biologic drugs has been the cost (estimated in the UK at £10,000 -£25,000 per patient per year). Biologic drugs are expensive to develop and produce, and unfortunately this condition could require very long treatment plans. This has been particularly important in countries outside of Western medicine where uptake is extremely low. However, this market is set for a remarkable change due to a recent shift in regulatory guidelines; the acceptance of biosimilars. Biosimilars are a regulatory means by which biologic drugs which have lost their patent protection are approved in a shortened pathway. Biosimilars are copies of the innovator drugs, similar to the generic drugs of small molecules, and in the same way these drugs are considerably cheaper than the original. Enbrel, Humira and Stelara are all highly attractive targets for biosimilars due to their high revenue and many companies have already identified them in their biosimilars pipeline. Stelara is a $1.5 billion drug whereas Enbrel, brings in $9 billion a year but these are both dwarfed by Humira which tops the market at over $10 billion. Clearly there is a sizable market opportunity for copycat drugs. [It should be noted that the revenue for these drugs is not solely based on the treatment of Psoriasis as these drugs have multiple indications].

Psoriasis is a complicated disease and can be tackled in different ways by these different drugs. All are inhibitors of potent cytokines in the body linked to the disease. Whatever  drug proves to have the most efficacies in the long run will lead the market and the huge potential revenue. This is particularly important for the company’s marketing biosimilars. Clearly there is a large established market with  a considerable number of people who would benefit from the drugs. In many circumstances it may come down to cost as to determine which  of these drugs are used as the primary treatment. This then switches the burden to the biosimilar manufacturers to reduce their costs to achieve market share. The lower costs of drugs coupled with higher utilization from doctors will increase the market not only in Western medicine but in the emerging markets. The patient population for this disease is forecast to increase steadily with an estimate of 16 million people diagnosed by 2022. As a chronic disease requiring perhaps lifelong treatment, it’s not hard to see the upside to investing in this market.

The Biosimilars may not be the only drugs used to target Psoriatic Arthritis. There are a number of  novel biologics being developed, Amgen and AstraZeneca’s (Brodalumab), Eli Lilly’s (Ixekizumab), Merck’s (Tildrakizumab), and J&J’s (Guselkumab) are all at late stages of development as treatments for this condition and each could slice a significant amount of market share should their molecule become the leading treatment. This market is set to become an interesting battle ground for pharmaceutical companies which ultimately will lower costs and become effective treatments that patients will benefit from.

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