Looking Forward
- PDF / 34,525 Bytes
- 1 Pages / 586 x 792 pts Page_size
- 75 Downloads / 225 Views
Looking Forward In 2006, a significant hurdle for progress of novel drugs will be the lack of a permanent US FDA Commissioner. A report from Lehman Brothers suggests that the FDA could approve 34 novel drugs this year – down on the 40-plus levels of the 1990s but a marked improvement on the 19 approvals for last year. Also, the analysts forecast 30 novel drugs filings in 2006, the same number as in 2005. However, these numbers could be difficult to achieve and are dependent on the FDA’s ability to make tough decisions without a permanent Commissioner in place. This is less concerning for the European pharma sector, which has a relatively low exposure to FDA decisions in 2006, accounting for 20% of expected approvals and 40% of expected filings. Overall, the average peak sales potential for novel approvals and for novel filings expected in 2006 is $US930 million and $US900 million, respectively – these figures are in line with recent years. Some good news for biotech companies – without a permanent FDA Commissioner, it seems unlikely that significant progress will be made on the pathway for approval of ‘follow-on biologics’. Overall, analysts at Lehman Brothers are expecting a good year for the European pharmaceutical industry, with growth in this sector expected to be higher than overall local market growth in 2006. However, they are forecasting the opposite scenario for the US and Japanese pharma sectors, which are likely to see pharma earnings grow at a rate below that of the overall local markets. Tracey Wright Editor
Pharmaceutical & Diagnostic Innovation 2006; Vol. 4, No. 1
Data Loading...
