Pharmaceutical Technology Europe - August 2010 - (Page 2)

The changing landscape for biosimilars Following predictions that biopharmaceuticals will soon make up 50% of new drug approvals, there has been a significant rise in interest in the field of biosimilars — approved new versions of innovator biopharm products developed following patent expiry. The European Medicines Agency (EMA) has implemented an approval scheme that specifically distinguishes between biosimilars and generic drugs in recognition that the generic approach is not scientifically appropriate for these products. In particular, the EMA requires extensive testing before a biosimilar can be approved and is using a case-by-case approach. In the US, the House of Representatives passed two healthcare bills to create an approval pathway for biosimilars in March 2010 as part of the Healthcare Reform legislation. The legislation stipulates that biosimilars the development must be subject to at of biosimilars least one clinical trial to because many demonstrate their safety companies will and efficacy. It also not see them as establishes a regulatory financially viable. framework by which The future of the manufacturers of biosimilars in the US biosimilars can gain market is dependent Dr Pablo Fern marketing approval upon the application andez PharmaNet from the FDA. For of the regulatory innovator biologics, the framework. legislation guarantees a period of Interested observers will be keen 12 years’ exclusive market access; to see how the new pathway for however, the World Generic biosimilars works out in practice when the first applications are filed and the FDA applies the new regulatory “...it is unlikely that a high framework. more than $2 billion dollars. Further interest in biosimilars will no doubt be driven by the fact that many of these drugs will reach patent expiry within the next 5–10 years. Looking at the medium-term prospects, it is unlikely that a high number of newcomers will enter the Western marketplace and only those who are able to cost-effectively develop high-quality molecules that meet EMA and FDA standards, are likely to remain in it. PTE number of newcomers will enter the Western marketplace...” Based on a contribution by Dr Pablo Fernandez, Senior Vice President, Medical Affairs, PharmaNet. To read the full version of this article, go to www.pharmtech.com/fernandez www.pharmanet.com Medicines Congress, which took place in February 2010, concluded that the extended exclusivity period may delay Outlook According to US market research firm Decision Resources, nearly onequarter of the top 100 drugs in 2007 were biologicals, and 13 of them achieved worldwide revenues of 1 CONTENTS 9 TAKING ON REGULATORS 3 EGA INTERVIEW 10 LAUNCHING A BIOSIMILAR 6 THE BIOSIMILARS MARKET 11 IMPACT ON INNOVATION 7 SWOT ANALYSIS 13 BIOSIMILARS NOT COMPELLING http://www.pharmtech.com/fernandez http://www.pharmanet.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - August 2010

Pharmaceutical Technology Europe - August 2010
Table of Contents
The Changing Landscape for Biosimilars
Interview with The European Generic Medicines Association
The Biosimilars Market Today and Tomorrow
A SWOT Analysis of the Biosimilars Market
Latest EU Guidelines Dissected
Taking On the Regulators: Is It Worth It?
Launching and Commercialising Biosimilars
Perception, Cost and the Impact on Biotech Innovation
Clinical and Cost Considerations of Developing a Biosimilar
True Biosimilars Do Not Offer a Compelling Business Case
What is Hindering the Uptake of Biosimilars

Pharmaceutical Technology Europe - August 2010