2009 saw considerably more full FDA approvals (BLAs, NDAs) for biopharmaceuticals products, with 19 (16 if you remove the 3 that were not all that new) compared to 11 and 10 approved in 2008 and 2007, respectively (so says the Biotechnology Information Institute).
According to the BII, a record number of products were approved for orphan indications, yet no biopharmaceuticals received approval for cancer indications. It’s only a matter of time, since cancer has a strong trial pipeline.
The full list of approved drugs, with an analysis, is available on their web site.
What’s interesting is the company origin for these approvals. Only five approvals from US-based firms. As discussed in pharmatech talk (Put Your Money Where Your Molecules Are) …
The study points out that only five approvals originated at US-based companies. This number decreased from seven in 2008. Johnson and Johnson (New Brunswick, NJ) and Genzyme (Cambridge, MA) were among the lucky few US companies to have products approved in 2009. The record number of FDA approvals is mainly grounds for celebration in Europe.
Pharmatech Talk does a nice job articulating some of the possible reasons for this trend, and it’s impact.