Victory in the USA


Thank you Advocates! FDA Issues Draft Guidance for Biosimilar Naming: A Proposed Rule that Designates Official Names and Proper Names for Certain Biological Products

Your efforts are making a difference.

GHLF is pleased to share that the Food and Drug Administration (FDA) released a draft guidance requiring biological products licensed under the Public Health Service Act (PHS Act) have unique names that include a FDA-designated suffix composed of four lowercase letters.

This will apply to both previously licensed products such as biologics as well as newly approved drugs like biosimilars. The nonproprietary name of originator biologics and their biosimilars will include a unique suffix.

The proposal is important because if finalized, it will allow physicians to easily differentiate the reference biologic from the biosimilar and one biosimilar from another manufacturer. If a patient experiences an adverse reaction from a biologic or biosimilar, physicians can quickly and accurately identify which product caused the problem, report it to the FDA and ensure optimum treatment for the patient.

GHLF in partnership with our patient advocates have worked on both the international and domestic fronts to ensure patient safety by advocating for unique names. Our Co-Founder and President Seth Ginsberg attended the World Health Organization (WHO)’s Front Page meeting about international nonproprietary names (INN) biological qualifiers (BQ) in June 2015.

Nationally, GHLF and advocates like you have weighed in, submitted letters to the FDA, and informed your local legislators.

If you are interested in learning about how you can comment and share your perspective on the FDA’s recent naming proposal, links to documents can be located on FDA’s Biosimilar webpage at: www.fda.gov/biosimilars or here:

• Link to Draft Guidance
• Link to the Notice of Availability
• Link to Proposed Rule
 
FDA also released a summary blog post on the topic which can be seen here:

FDA Voice Blog on Naming and Biological Products.