Abbott Submits Petition to FDA to Not Approve Biosimilar

Abbott Submits Petition to FDA to Not Approve Biosimilar

May 2nd, 2012 // 12:42 pm @


In a move that is sure to raise debate about the path forward for biosimilars, Abbott Laboratories has filed a citizen’s petition with the FDA in which the drugmaker asks the agency not to approve any biosimilar for its Humira treatment for rheumatoid arthritis. On what grounds? Abbott argues that the FDA would have no choice but to use trade secrets submitted to the agency when approval for Humira was first sought.

“Under well-established Supreme Court jurisprudence, FDA’s use of the trade secrets in (Abbott’s) Biologics License Applications to support approval of competitor products would frustrate (its) investment-backed expectation regarding their property and would constitute a taking under the Fifth Amendment to the US Constitution that requires just compensation,” Abbott writes in its 30-page petition, which was filed on April 2.

The drugmaker goes on to note that at least three companies have begun pre-clinical or clinical testing of a Humira biosimilar. And so, Abbott writes the FDA should not “accept for filing, file, approve or discuss with any company, or otherwise taking any action indicating that the agency will consider any application or any investigational new drug application for a biosimlar” that cites the Humira BLA.

Not surprisingly, the logic is extended to refer to any drugmaker or biotech that submitted a BLA for product approval prior to the enactment of the Biologic Price Competition and Innovation Act of 2009, which is incorporated into the Affordable Care Act that was signed into law in March 2010. Abbott stresses, by the way, that previous court rulings found that data submitted to the FDA constitutes trade secrets (here is the citizen’s petition).

Abbott appears to have set the stage for this argument more than a year ago. Last August, The Food and Drug Law Journal ran an essay about the Constitutional protection of trade secrets under the Affordable Care Act that was written by Richard Epstein, who is a New York University School of Law professor and a senior lecturer at the University of Chicago. Abbott supported his research, although Epstein wrote that the conclusions were his own. Here is his summary…

“The Biologics Price Competition and Innovation Act of 2009 introduced an elaborate statutory bargain under which FDA may approve biosimilars that are ‘highly similar’ to a ‘reference product’ that has been approved by FDA through a full biologics license application. In exchange for this partial taking of its trade secrets, the reference product sponsor receives a 12-year exclusivity period and the opportunity for pre-market patent litigation. This statutory bargain is protected by strong constitutional constraints. In particular, the doctrine of unconstitutional conditions prevents Congress from simply announcing that FDA may take the pioneer’s trade secrets,” Epstein wrote (see here).

“Moreover, the statutory quid pro quo serves as the just compensation for the partial taking. Accordingly, FDA must use caution in implementing the Biosimilars Act so as to preserve this delicate balance. For example, biosimilar applicants cannot bypass the mandatory patent exchange process, and FDA should create procedures ensuring that the taking of the pioneer’s trade secrets does not exceed what is envisioned by the Act. The bargain also raises serious constitutional concerns if it is applied retroactively to pre-enactment products. In any event, FDA may not approve biosimilars of pre-enactment products given the lack of clear Congressional intent for a retroactive effect,” Epstein concludes.

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