The current Nature Reviews Drug Discovery has a short analysis of last year’s FDA approvals for new molecular entities (NME) and biologics:

“The US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 15 new molecular entities and 6 new biologics in 2010. The total of 21 new products falls below the 25 approved in 2009 and the 24 in 2008.”

Here’s a graphic of the overall trend since 1996:

2010 FDA drug approvals

Source: Nature Reviews Drug Discovery

You can see that for drugs, the trend has been downwards since 1996, although the last few years have been fairly stable. The biologics, while only a small proportion of the total have been steady.

What you can’t see in the chart above is:

  1. Ratio of submissions to approvals
  2. Impact of generic approvals
  3. Shift from mass market primary care drugs to specialty and orphan drugs.

Over the next few years within the oncology sector, for example, I think we will see more targeted drugs emerging that affect smaller patient populations.   A good example of this is Pfizer’s crizotinib, which was filed last month for ALK translocations in non-small cell lung cancer (NSCLC).  The target population is only ~5% of NSCLC.

The other trend that hasn’t yet made a huge impact, but will likely do so in future, is biosimilars and biobetters. That’s a whole different ball game entirely.

What do you think will happen this year? Hopefully there won’t be as many complete response letters (CRL) in 2011 as there were in 2010!


ResearchBlogging.orgMullard, A. (2011). 2010 FDA drug approvals Nature Reviews Drug Discovery, 10 (2), 82-85 DOI: 10.1038/nrd3370