So we knew that the generic drug industry was less than thrilled with the outcome of the follow-on biologics legislative debate, but we didn't realize it was this bad.
That is our conclusion after participating in a webinar hosted by the Washington Legal Foundation on the new biosimilars pathway enacted as part of the health care reform law. (You can watch a replay of the webinar here; and, yes, that is your humble blogger moderating...)
With so much attention focused on the exclusivity issue during the legislative debate, we were excited to have the opportunity at least to start to talk about the nuts-and-bolts of making follow-on biologics happen in the real world.
But boy does it sound like an uphill climb from here. We were struck by the case made by Bob Dormer, a founding partner of the DC law firm Hyman Phelps & McNamara, who argues that--all things considered--sponsors are better off just filing a conventional BLA than bothering with the new "pathway" for biosimilars created by the health care reform law.
Dormer offered the following points:
That may be the key point: how will FDA translate the legislation into a regulatory pathway? As the WLF panelists agreed, there are far more questions than answers at this point.
We will of course be covering the details of FOBs implementation. And we will be hosting our own webinar on the theme in June; click here for details.
Image courtesy of flickrer B Tal who notes this piece of ancient wisdom: if we do not change our direction, we are likely to end up where we are headed.