This is another interesting post from the In the Pipeline blog. It reviews some interesting spin on the old "me-too" drug debate. We've all heard (especially us bloggers who regularly promulgate this stuff - just read through this blog) the knocks on drug makers for - lack of innovation, seeking easy profits at the expense of chasing the tough medical challenges, putting marketing over science, employing defensive strategies to fend off competition rather than blazing a new trail.
But this post, pulls out some interesting data to consider for an article in Nature Reviews Drug Discovery. The article examines first-in-class drugs from 94 different therapeutic classes over 40 years. Several observations emerge:
- Over that period the time it took a second entry to enter a therapeutic class dropped from 9 years to only 1.7 years - same with 3rd or later entries
- That means the so-called 'me-too' drugs had to have been started prior to approval of the first-in-class drugs
- Since the 90's, the second drug in a class has already been filed into clinical trials before the first is approved - 64% of the time it has already begun phase III
- Patent data also show the follow-on drugs have been filed before the first-in-class drug was ever approved
The upshot of the data and the post is that what we really have is a race to be first-in-class and that many of the so-called 'me-too' drugs are simply the also-rans in this race. Now that same thinking likely doesn't hold for the 13th beta-blocker to seek approval but we can likely apply the benefit of the doubt to the first two or three followers.
First-to-market and first-in-class does mean something economically -- but the second and third guys may not be copy cats in the strictest sense - merely losers in the sprint to the finish line. So, do drug companies copy each other's successes or do some merely win the race to be first?