Biosimilars: Beyond the first product wave

Abstract

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.

• When will a significant biosimilar market develop?
• Could an abridged regulatory process really benefit biosimilar manufacturers?
• Will biosimilars be undermined by a price war?
• Is there political will to find a solution in the US?
• Will doctors' attitudes be key to the sector' s success?

The biosimilar sector continues to attract huge interest and controversy. Most generic manufacturers are actively involved in it, either directly or indirectly. The successful ones will be those with the patience, resources and above all money to invest now, in order to gain in the future. Even for the vanguard, however, those gains are some years off.

Providing...

• A thorough review of the latest regulatory situation in the USA, Europe and selected markets
• An examination of products that are currently available for development:
  • EPO
  • HGH
  • G-CSF
  • Human Insulin
  • Interferon
• Analysis of upcoming product opportunities such as Biogen Idec/Roche' s rituximab and Amgen/Wyeth' s etanercept
• A review of key issues such as development costs and legal matters
• Consideration of upcoming product opportunities
• Examination of the factors such as pricing and clinician response
• A review of the work of 47 companies actively developing biosimilar products

About the Author

The report has been written by Espicom' s Chief Healthcare Markets Analyst, Andy Crofts.

Andy has over 12 years experience of analysing pharmaceutical and healthcare markets, with a particular interest in global generic pharmaceuticals. He is editor of a range of Espicom' s leading market analysis services, including World Pharmaceutical Markets, World Generic Markets and Generic Companies Analysis.