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.
