FDA approach to retrospectively naming biologicals

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How the US Food and Drug Administration’s (FDA) is tackling retrospective naming of biologicals was an issue covered by Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research (CDER). Dr Taylor gave an update on FDA’s naming policies for biologicals, including biosimilars [1].

Naming 3 V13J04

FDA published draft guidance on naming biologicals in August 2015 [2] and issued the final version of this guidance in January 2017 [3]. The naming convention outlined in the guidance applies to all products, both prospectively and retrospectively. The agency’s approach to applying the naming convention retrospectively is outlined here. 

For retrospective non-proprietary naming, FDA is continuing to consider the process for implementing the naming convention for previously licensed products.

FDA issued a proposed rule to modify the non-proprietary name of six currently marketed biologicals in August 2015. However, healthcare organizations have expressed their ‘grave concerns’ over the ‘enormous financial consequences’. Wolters Kluwer has said that changes to existing electronic health record, billing and pharmacy systems and databases, as well as prescribing systems and millions of patient records could cost providers billions [4]. The agency has said that it ‘will continue working with stakeholders, including manufacturers, health systems and informatics providers, to better understand these costs’.

The final naming guidance permits biologic license application (BLA) holders to propose a suffix for use in the proper name of currently licensed biologicals. The process for BLA holders to propose suffixes is part of an information collection subject to Office of Management and Budget (OMB) review under the Paperwork Reduction Act.

Three examples of the currently marketed biologicals that will require name changes under the new guidance are:

Biological type Proprietary name Non-proprietary name Change required
Originator Neupogen filgrastim Suffix to be added
Biosimilar Zarxio filgrastim-sndz Suffix to be changed to be meaningless
Related biological Granix tbo-filgrastim Prefix to be removed and suffix added

Reasons for the changes, according to the FDA are:

  1. Biological drug substance terms would be associated (not synonyms)
  2. Allows each biological drug substance to be uniquely identified
  3. Addresses ambiguity with using non‐proprietary names as synonyms at the UNII substance level
  4. Support the non‐proprietary name/biological drug substance relationship throughout the life cycle.

Related articles
FDA approach to prospectively naming biologicals

FDA update on naming biologicals

1. Taylor K. FDA Update on biological product naming. DIA Biosimilars Conference; 24-25 October 2017; Bethesda, Maryland, USA.
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-naming-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
4. GaBI Online - Generics and Biosimilars Initiative. FDA biologicals naming guidance could cost providers billions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Biosimilars/General/FDA-biologicals-naming-guidance-could-cost-providers-billions

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