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?
Posted by Bruce Lehr Jan 26th 2011.
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