This from today's Xconomy. Abbott has filed a citizen's petition with the FDA to protect Humira by challenging the notion that the agency can refer to Abbott's Humira BLA filing. Their argument (posted here and here before) is that this would violate the "takings clause" in the 5th amendment that prohibits the taking of "private property for public use without just compensation."
Abbott has argued that its BLA contains trade secrets that would be "taken" without compensation should the FDA use the BLA contents to potentially license a new biosimilar. Since Abbott's Humira sells in neighborhood of $9 B per annum worldwide, "just compensation" would be considerable in this instance.
So we can expect pharma industry participants to line up on both sides of the question with their teams of lawywers? On one side, the innovators who have no plan to introduce biosimilars will join Abbott. On the other, we should expect innovators who do have plans to introduce biosimilars and companies who plan to focus only on biosimilars. There is bound to be plenty of action.
We should also have the government and healthcare advocates lining up to argue for biosimilars on its economic merits to reduce costs in the health care system and for patients. And on the other side, free market forces will argue for the innovators right to protect their IP and earn a return on its investment for their shareholders. Both won't be right or simultaneously get their way. Let the games begin.
Posted by Bruce Lehr Jun 25th 2012.