Research and Markets: The Congressional Budget Office Estimates the US Could Save US$25 Billion from the Use of Biosimilars Over 10 Years

DUBLIN--(Business Wire)--
Research and Markets
(http://www.researchandmarkets.com/research/36f69b/biosimilars_beyon) has
announced the addition of the "Biosimilars: Beyond the first product wave"
report to their offering.

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.

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.

Key Topics Covered:

* Foreword
* Executive Summary
* Products in the 'first wave'
* Erythropoietin (Epoetin, EPO)
* Human Growth Hormone (somatropin)
* G-CSF
* Human Insulin
* Interferon
* Beyond the first wave
* Monoclonal antibodies
* Why are biosimilars an issue now?
* Rising cost of healthcare
* Is there a commercially viable market?
* The price reduction of the biosimilar
* Patient population
* Physician & patient acceptance
* Regulatory attitude
* Extent of existing competition
* Who will be the players in the market?
* INDEX OF TABLES

For more information visit
http://www.researchandmarkets.com/research/36f69b/biosimilars_beyon

Source: Espicom Business Intelligence Ltd

Research and Markets
Laura Wood, Senior Manager,
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

Copyright Business Wire 2009