Forbes: Abbott Petitions FDA To Prevent Humira Biosimilars

RA Guy Community News

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.

Read More: http://www.forbes.com/sites/edsilverman/2012/04/30/abbott-petitions-fda-to-prevent-humira-biosimilars/