FDA Guidance Suggests Distinct Names for Biosimilars
August 28, 2015
by Amanda Conschafter, blog editor
The FDA has issued new guidance that proposes giving distinct non-proprietary names to biologics and biosimilars. Distinct names will prevent unintended substitution of non-interchangeable therapies and will aid post-market tracking and monitoring, FDA officials explained in an August 27 blog post. The guidance comes nearly six months after the FDA’s first biosimilar approval.
The approach would attach randomly generated four-letter suffixes to biological medicines’ non-proprietary names. The proposed naming system differs from the “placeholder” approach that the FDA used for the first U.S. biosimilar, in which the four-letter suffix identified the biosimilar’s manufacturer. The FDA has not, however, entirely abandoned such an approach. The agency’s guidance urges public comment on “the benefits and challenges of other naming approaches, such as a suffix derived from the name of the license holder.”
The FDA has also requested public input on naming rules for interchangeable biosimilars – specifically, whether the brand-name biologic and the follow-on biosimilar should share the same nonproprietary name and suffix. Some physicians and patient advocates have raised concerns that identical names may inaccurately suggest identical products and effects on patients. In fact, manufacturers cannot duplicate a biological product exactly because the medications derive from living cells or tissue.
The proposed naming system also presents the need to update the naming approach used for some biologics that are already approved. The FDA invites public input on this issue as well, and has issued a proposed rule to add a distinct suffix to existing non-proprietary names for biologics for which an approved or public biosimilar approval application exists. Public input is due by October 27.Tags: Biologics
Categorized in: Blog