The US Food and Drug Administration (FDA) has issued a new draft guidance document concerning non-proprietary name suffixes for biological products.
The draft guideline on the non-proprietary naming of biological products was published in a Federal Register announcement on 8 March 2019. The guidance is intended to update the previous guidance, which was issued in January 2017 [1]. FDA had previously said that it would assign a non-proprietary name for all originator biologicals, related biologicals and biosimilars that includes an ‘FDA-designated suffix’. This ‘proper name’ should consist of a combination of the ‘core name’ and distinguishable suffix, ‘devoid of meaning’ and be ‘composed of four lowercase letters’.
The new draft guidance will update the previous guidance and most importantly means that already approved biologicals will not be required to revise their names.
Nonproprietary Naming of Biological Products: Update
Date: March 2019
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM632806.pdf
The guidance includes three key changes to its approach to non-proprietary name suffixes.
1. The FDA no longer intends to modify the proper names of biologicals that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names.
2. The FDA does not intend to apply the naming convention to the proper names of transition biologicals. These products are biologicals, such as insulin, that are currently approved under New Drug Applications (NDAs) rather than Biologic License Applications (BLAs). In March 2020, however, these existing NDAs will be converted to BLAs.
3. For interchangeable biosimilars, the FDA intends to designate a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.
FDA Commissioner Dr Scott Gottlieb stated that the first change was in response to concerns from stakeholders that changing the names of older biologicals to add suffixes would impose substantial costs on the healthcare system and could cause confusion for patients. In view of these potential issues, and considering the fact that since these products are already generally distinguishable by their proper names, the agency determined that its pharmacovigilance goals could be accomplished without extending the new naming convention to previously licensed products.
Regarding the second change, this is stated as being carried out in order to minimize the burden, ensure patient stability and advance the development of biosimilar and interchangeable products.
Finally, FDA is also considering whether distinguishable proper names with suffixes are necessary for vaccines. It is therefore ‘carefully considering whether the information that’s already available to us through identification systems associated with the administration of vaccines is sufficiently robust for ensuring pharmacovigilance’.
However, according to the Association for Affordable Medicines (AAM), FDA’s decision to require 4-letter, non-meaningful suffixes for biosimilars, interchangeable biosimilars and new biologicals, but not for already approved biologicals, could affect the uptake of biosimilars. The AAM says that this decision by the agency ‘presents a significant, artificial barrier to biosimilars that is misaligned with the agency’s own Biosimilars Action Plan and the Trump administration’s commitment to lowering drug prices for America’s patients’.
Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 22]. Available from:
www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
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Source: AAM, Federal Register, US FDA
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