Biogenerics 2006: Challenges ahead for an emerging market

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.