FDA Submits Biological Products Naming Rule to OMB

August 31, 2015

The FDA submitted Designation of Official Names and Proper Names for Certain Biological Products as a proposed rule to the Office of Management and Budget in late August, but would not comment on whether it is the expected guidance on naming biosimilars.

A link to the document on the website wasn’t active.

In April, the FDA announced that it would provide guidance before the end of the year on naming biosimilars — a hot-button topic among drugmakers. In March, the FDA approved Sandoz’s Zarxio biosimilar of Amgen’s blockbuster chemotherapy drug Neupogen, and gave it the placeholder name filgrastim-sndz.

A spokesman said the FDA will post a notice when the new guidance is released. — John Bechtel