A preliminary list of the New Drug Application has been released by the U.S. Food and Drug Administration (FDA), which will be converted to the Biologics License Application (BLA) on 23 March 2020. The reason for this shift is believed to be the Biologics Price Competition and Innovation Act of 2009 and its biases on the protein product regulations.

The Innovation Act of 2009 states that the regulation of the protein products will be done by amending the definition of a “biological product”, which include a protein aloof of any chemically synthesized polypeptide. The FDA has also compiled a preliminary list of approved biologics under the FD&C Act to enhance transparency and facilitate planning for transition.