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Home » FDA Submits Biological Products Naming Rule to OMB
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
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