WLF urges FDA to defer consideration of biosimilars

The Washington Legal Foundation said FDA should defer all work on regulatory applications for biosimilars that reference biologics for which a BLA was submitted prior to March 23, 2010, when the Biologics Price Competition and Innovation Act (BPCIA) was signed into law. In Abbott Laboratories (NYSE:ABT), the foundation said approval of biosimilar applications would require use of trade secrets submitted to FDA by sponsors of the reference biologics. WLF said this would expose the federal government to "massive liability" for the loss in value of the trade secrets under the Fifth Amendment's takings clause, which protects trade secrets. ...