With the prospect of high-profile, high-value biosimilar products on the horizon, the sector is poised to realise its full potential - but only if the US can establish a regulatory pathway. This report addresses key issues and provides insight into how the sector may develop.
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With the prospect of high-profile, high-value biosimilar products on the horizon, the sector is poised to realise its full potential - but only if the US can establish a regulatory pathway.
The future of the pharmaceutical industry lies with biotechnology. Biotech drugs account for around 10-15% of the current pharmaceutical market, and the sector is outperforming the market as a whole in terms of growth.
The need for a settled market environment is essential if the growing number of products losing patent protection in the next 5 years is to be exploited. However, progress is painfully slow and the focus is now on three critical issues:
US regulatory deal more likely than ever before
The continued wrangling between the FDA, Congress and vested interests and the continuing lack of a regulatory pathway for biosimilars in the USA is stifling market expansion domestically and globally. Agreement is, however, more likely in 2009 than at any time before, but even if legislation is passed, it is unclear how sympathetic it will be to the economically viable development of biosimilars in the USA. With a wider portfolio of products becoming available there is a mounting cost saving argument as the Congressional Budget Office estimates the US could save US$25 billion from the use of biosimilars over 10 years.
A more valuable product range is on the horizon
The current biosimilar products are relatively low cost. However, second generation products, including monoclonal antibodies indicated for high-value conditions such as cancer and CNS, will be more attractive to manufacturers.
Clinical acceptance - a determining factor?
Biological drugs are complicated, expensive products used to treat complex conditions. Given this, it may be difficult for manufacturers to persuade physicians to prescribe and use generic versions. In some countries, such as France or Japan, prescribing of generics is relatively unpopular, so the task will be more difficult for biosimilars where worries over equivalence will be greater and less easy to counter.
How this pans out in the future is crucial for the whole pharmaceutical market. Biosimilars: Beyond the first product wave is a new, critical 200-page management report, published in October 2009 by leading generic industry publisher Espicom Business Intelligence, which addresses these and other key issues of concern and provides insight into how the sector may develop.
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