Sandoz vs. HHS and FDA: The Omnitrope Lawsuit
Regular readers might recall my somewhat bold prediction at the beginning of this year that the first NDA for a “biogeneric” or “follow-on biologic” would be approved in 2005. I presumed that it would be Omnitrope (recombinant human growth hormone, Sandoz), referencing Genotropin, using the 505(b)(2) pathway for approval. Looks I was was wrong, sort of. You see, another recombinant follow-on biologic was approved in August (Fortical, recombinant salmon calcitonin, Unigene), referencing Miacalcin, using this pathway. Interestingly, although I anticipated final action on the Omnitrope NDA by the time that Fortical was approved, it never came. Now we know the specific circumstances surrounding the Omnitrope NDA approval delay.
In the lawsuit recently filed in the US District Court (Washington) against HHS and FDA, Sandoz has charged that FDA has been delinquent in its duties to offer a final action timely in its review of the Omnitrope NDA (which we learned, vide infra, was filed in October 2003), based on the reasoning that there were “unresolved scientific and legal issues that relate to [the] NDA.” However, Sandoz makes the case–and I think they make it very effectively–that these issues have been effectively resolved and that final action should now be taken on the NDA. FDA, for its part, maintains that they have no timetable for final action. Presumably, they are relying on a loophole of the FDC Act and/or PDUFA to shield themselves from the requirement to take a final action.
This is a very interesting case from every perspective, scientific, legal and political and should be observed closely. The outcome could well decide when the first major recombinant follow-on biologic, and the first human recombinant follow-on biologic hits the US market.
