There are potentially big rewards for companies who can overcome the regulatory, legal and technical obstacles related to biogenerics. But there are dangers too - that is why this critical, analysis is essential reading.
Biological drugs account for 10-15% of the world pharmaceutical market. This is equal to around US$30 billion in the USA alone. The biologicals sector is outperforming the pharmaceutical industry as a whole, growing at double the pace in some cases. But the development of the biogenerics sector will only come after some significant problems have been tackled.
CONSIDER...
Biologic drugs are expensive and increasingly widely-used. For chemical drugs, generic versions of off-patent products have helped to reduce pharmacy bills and increase funding for new products. It would seem obvious, therefore, for companies to develop generic versions of the older biologic drugs, and for health payers to welcome them. But achieving this has proved far from straightforward.
Early market entry in the USA is not a practical proposition. The nature of the current regulatory system precludes approval in most cases. The FDA has yet to issue detailed guidance on the topic, although this is planned for 2005. Only then can Congress begin the legislative process. Given the time this will probably take, biogenerics are unlikely to appear on the US market until at least 2010.
The European Union is some years ahead of the USA, on paper at least. The 2003 EU regulatory reforms make specific provision for biogenerics, and the EMEA has issued guidance documents on most of
the major products. No product has yet been approved in the EU, however, with a number of companies still preparing regulatory submissions. Market entry in two to three years is a realistic prospect.
This key report answers the important questions
For everyone involved in this emerging market sector Biogenerics 2005: An Emerging Global Market? (published September 2005) is essential reading. Thoroughly researched and including the very latest information, the report distils and analyses the key issues in more than 100 thought-provoking pages:
- What are the regulatory hurdles to be overcome?
- How might the political environment affect development?
- How might companies overcome technical issues related to, for example, bioequivalence?
- US/Europe regulation: USA in the slow lane but for how long?
- What products have recently been approved and which are under consideration?
- Where are the best opportunities?
- The commercial/competitive cost of biogenerics: when is it worth it?
Report Contents
- Executive summary
- The biogeneric market environment in the USA
- The biogeneric market environment in the EU
- Products under consideration
- Biogenerics manufacturers profiles
- Market data
Whats in a name?
This report uses the term "biogenerics" to describe unbranded off-patent biological products. Others use
- Biosimilars
- Follow-on biologicals
- Second-generation biological
- Whatever the name, the issues are the same!
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