Approximately 75% of pharmacists indicated that they would be confident or very confident in substituting an interchangeable biosimilar with the reference product if both shared the same active ingredient or non-proprietary name of the reference biological, according to a survey published in JMCP [1].
The Academy of Managed Care Pharmacy, the American Pharmacists Association, and the American Society of Health-System Pharmacists, the three associations that represent pharmacists across the United States, fielded a survey to their membership or a partial segment of their membership via an online survey in November and December 2014, and a total of 93 responses were collected.
The survey showed that pharmacists, however, were less confident with such substitution when the non-proprietary name was completely different (only 25% felt confident or very confident) or was different because of a prefix or suffix (37% felt confident or very confident).
Pharmacists were also asked about their level of familiarity with biosimilars. Based on the responses, pharmacists will require substantial education on biosimilars and interchangeable biosimilars prior to the launch of the first US product. Education should focus on 3 areas: 1) instances where substitution is allowed according to US Food and Drug Administration (FDA) approval, i.e. as a biosimilar or interchangeable biological; 2) appropriate recording of biological dispensed for pharmacovigilance efforts; and 3) notification requirements driven by specific state laws.
Finally, when asked about reporting practices for biologicals dispensed, the majority of respondents (70%) indicated using National Drug Codes to record use of biologicals; however, 10% of respondents reported using either the non-proprietary name or the Healthcare Common Procedure Coding System code as the identifier.
This survey highlights the importance of carefully evaluating the impact of the naming convention of biosimilars to the different stakeholders. According to this survey, pharmacists feel most confident in biosimilar substitution when the biosimilar and the reference product share the same non-proprietary name.
The recent approval of the first biosimilar in the US market on 6 March 2015, Zarxio™, a biosimilar to Neupogen® (filgrastim), still left the naming question unresolved, as FDA assigned to it only a placeholder non-proprietary name for this product as ‘filgrastim-sndz’ [2]. This placeholder, however, follows the approach of the proposal of the INN Expert Group at the World Health Organization (WHO) of developing a biological qualifier (4-letter code, randomly assigned) that would be added to non- proprietary names to identify manufacturer and production site of any biological (innovator and biosimilar products) [3, 4].
Conflict of interest
The authors report no financial conflicts of interest related to the subject or products mentioned in the published paper. The manuscript was written by Fernandez-Lopez, Kazzaz and Bashir and revised by McLaughlin, Fernandez-Lopez, Kazzaz and Bashir.
Abstracted by Sara Fernandez-Lopez, PhD, MBA, Director, Reimbursement Strategy, Xcenda, USA.
Editor’s comments
Readers interested to learn more about survey findings among European physicians on biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Biosimilars naming, label transparency and authority of choice – survey findings among European physicians
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal platform – please send us your submission here.
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References
1. Fernandez-Lopez S, et al. Assessment of pharmacists’ views on biosimilar naming conventions. J Manag Care Spec Pharm. 2015;21(3):188-95.
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. More discussion over WHO biological qualifier [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Biosimilars/General/More-discussion-over-WHO-biological-qualifier
4. World Health Organization. Biological qualifier: an INN proposal. INN Working Doc. 14.342. Revised draft July 2014 [homepage on the Internet]. 2014 Jul 30 [cited 2015 Mar 20]. Available from: http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf
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