FDA Proposed Naming Convention for Biosimilars
The FDA released a draft guidance that suggested a standardized naming convention for biosimilars: adding a 4-letter, lowercase suffix that is devoid of meaning to the core name of the originator biologic. An example provided in the draft guidance posits if the originator biologic was named replicamab-cznm, the biosimilar could be named replicamab-hixf.
The FDA requested public feedback on whether interchangeable biological products should include a different suffix or if it should have the same suffix as the reference product. Another example provided in the draft guidance posits both the reference product and interchangeable product could be named replicamab-cznm.
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With this solution, the FDA is hoping to address 2 main concerns: (1) prevent inadvertent substitution of a biological product that is not deemed interchangeable; and (2) support safety monitoring of all biological products on the market by making it simpler to track the usage of biological products across all health care settings.—Melissa D. Cooper
Reference
1. Nonproprietary naming of biological products: guidance for industry [draft guidance]. Federal Food and Drug Administration; August 2015. https://www.fda. gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987.pdf Accessed August 28, 2015.
2. Woodcock J, Midthun K. Naming and Biological Products [Internet]. FDA Voice. 2015 August 27. Available at: https://blogs.fda.gov/fdavoice/index.php/ tag/replicamab-cznm/. Accessed August 28, 2015.
