Sharp rise in US FDA approvals of biopharmaceuticals in 2009, highest since 2005, says BII

The US Food and Drug Administration's approvals of new biopharmaceutical products increased significantly in 2009, reversing a trend of low numbers and a decline in approvals in recent years.

The FDA granted 19 full approvals (BLAs, NDAs) for biopharmaceuticals products in 2009, according to the findings of the Biotechnology Information Institute (BII). This was the highest number of new product approvals since 2005, and considerably more than the 11 and 10 approved in 2008 and 2007, respectively. Eliminating three approvals for products that are not really new, 16 New Biopharmaceutical Entities (NBEs) were cleared in 2009, another recent record. A record number of products were approved for orphan indications. However, noted the BII, no biopharmaceuticals received approval for cancer indications, continuing a recent trend.

Compared to recent years: there was a further increase in the number of recombinant proteins (seven); 2009 new products are expected to collectively attain significantly higher peak sales levels and have more impact on health care; and there were even fewer products from USA-based and smaller biotechnology-type companies.