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Letter to FDA on naming

4/ 09


AUTHOR: 50SN Staff

DATE: Apr 09, 2015


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Letter to FDA on naming

The clock starts ticking as soon as a patient experiences symptoms of an adverse reaction. When the worst happens, we want our healthcare team to have the maximum information available to them in order to find the cause quickly and accurately.

That is why the Global Healthy Living Foundation (GHLF) and its members fully support the FDA’s decision to incorporate a distinguishable name for the first approved biosimilar – filgrastim-sndz. There has been a lot of debate about whether or not biosimilars should share the exact same name as the biologics they mimic.  After surveying 250 patient advocates in our community, we have discovered that the overwhelming majority of patients believe biosimilars should not share the same name as the biologics.

The key are those last four digits (s-n-d-z). Policy nerds call it a “four digit qualifier”. By applying those four-digits to the end of the scientific name, you make it distinguishable.  It’s important because it allows physicians to easily differentiate the biologic from the biosimilar. If a patient experiences an adverse reaction from a biologic or biosimilar, physicians will need to quickly figure out which product caused the problem so that they can best treat the patient.

GHLF requests that all members of Seth’s 50-State Network join us in commending FDA for their decision to put patient safety first. You can do this by signing on to our letter that we will be sending this April.

 For a link to the letter please click here.