The US Food and Drug Administration (FDA) issued draft guidance on the non-proprietary naming of biological products in August 2015 [2]. However, the guidance continues to be in flux and does not address naming for products given an interchangeable designation.

This study by the AMCP and HOPA aimed to determine pharmacists’ perceptions of biosimilar naming conventions and the impact it might have on pharmacists’ confidence to dispense biosimilars.

The cross-sectional survey of 781 pharmacists was conducted using an online survey software program. When asked directly, pharmacists reported a preference for a non-proprietary proper name with a designated suffix for biosimilars. However, use of such a naming strategy was associated with a decrease in confidence of substituting a biosimilar for the originator biological.

The preference for unique names for biologicals correlates with a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). That survey found that the majority of responders (68%) thought that FDA should require a distinct non-proprietary scientific name for every biological product – originator or biosimilar. While a total of 77% of respondents thought that a manufacturer-specific suffix should be included in the name of each biological product [3]. The FDA draft guidance proposes a meaningless four-letter suffix [2].

The author therefore concluded that this might impact the ‘willingness of some pharmacists to dispense biosimilars’ or might result in pharmacists transferring this lower level of confidence in the product to the patient. ‘This effect will be minimized if interchangeable biologics share the same nonproprietary name as the reference biologics’. Additional research is needed to determine the overall impact this may have on actual use of biosimilars.

Conflict of interest
The author of the research paper [1] declared that there was no conflict of interest.

Editor’s comment
Readers interested to learn more about naming of biologicals are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

US FDA proposals for naming of biologicals and labelling of biosimilars

Biosimilars naming, label transparency and authority of choice – survey findings among European physicians

If you are interested in contributing a research article in a similar area to GaBI Journal, please send us your submission here.

Related articles
FDA withdraws biosimilar suffix proposal

US rheumatologists in favour of distinct names for biosimilars

References
1. Tomaszewski D. Biosimilar naming conventions: pharmacist perceptions and impact on confidence in dispensing biologics. J Manag Care Spec Pharm. 2016;22(8):919-26.
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on naming biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-naming-biosimilars
3. Schneider P, Reilly MS. Naming and labelling of biologicals – the perspective of hospital and retail pharmacists. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(4):151-5. doi:10.5639/gabij.2016.0504.040

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