Abstract
The world biogenerics market is about to develop on a very large scale. The
approval of generic growth hormones in the US and Europe has finally occurred
and this has created a new source of revenue for generic companies. After
years of indecision and false starts, it appears that generic biotech drugs
are going to become available on the large, lucrative markets of the US and
Europe. However, despite the introduction of Biosimilar guidelines by the EU
and a heightening of the debate within the FDA, key questions for the
pharmaceutical industry still remain concerning this new type of generic drug.
The main issue is the degree to which the new biosimilar but not bioequivalent
generic drugs will have to be tested prior to market launch. The delay in firm
guidance and legislation is concerned almost entirely with this issue.
Visiongain's report: Biogenerics, 2006 (Challenges ahead for an emerging
market) discusses all the implications of legislation and how it will affect
the market for these drugs.
Read visiongain's brand new report to find out:
Which products will be targeted as the first biogeneric drugs? What can the
biotech industry do to combat the threat of biogenerics? Which companies are
developing generic biological products? The following issues are covered in
detail:
Drivers and restraints of the emerging world biogenerics market Regulatory
developments in the EU and the US The correct approach to demonstrating
bioequivalence Descriptions and financial data for the first likely biogeneric
drugs Strategies for dealing with the biogeneric threat Company profiles of
the leading companies producing biogenerics An assessment of the role that
Indian and Chinese companies will play on the global market
Why should you buy this report?
In 2005 the world market for biotech drugs was worth almost $70bn and
companies from all areas of the industry want to establish how much an impact
biogeneric equivalents will have on this growing market. This report aims to
explain the regulatory and scientific issues that will influence the success
of biogenerics, as well as discuss the current trends and opinions within the
industry.
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