The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey in which they asked 400 US physicians for their views on the labelling of biosimilar medicines, and a separate survey in which they asked another 400 US physicians for their views on the naming of biosimilar medicines [1]. All those surveyed were prescribers of biological medicines. The surveys were carried out in the run up to the release of guidance from the US Food and Drug Administration (FDA) on the non-proprietary naming of biological products.
The market uptake of biosimilars in the US will depend on regulatory policies [2], which will rely on an agreed naming and labelling system. An earlier survey of the views of European physicians on familiarity of biosimilar medicines had demonstrated the need for distinguishable non-proprietary names to be given to all biologicals [3]. There have also been calls for clear regulation in this area from Latin America [4], Malaysia [5], and beyond.
FDA issued its guidance on the non-proprietary naming of biological products in January 2017 [6]. In the months running up to this announcement, ASBM invited 5,423 physicians in the US to complete a study on the naming of biologicals. A total of 433 physicians responded, of which 400 prescribers of biologicals qualified and completed the study. Prescribers were asked for their feedback on an earlier draft non-proprietary biologicals naming proposal that had been issued by FDA in August 2015.
FDA has said a non-proprietary name should be assigned for all originator biologicals, related biologicals and biosimilars that include an FDA-designated suffix. The ‘proper name’ will consist of a combination of the ‘core name’ and distinguishable suffix, which will be devoid of meaning and be composed of four lowercase letters.
FDA’s proposal for a random suffix on a product’s name that does not indicate the manufacturer was not broadly welcomed by the prescribers included in the ASBM naming survey, with only 9% of respondents agreeing with FDA. Instead, most physicians surveyed (60%) would prefer a suffix on the non-proprietary scientific name that is indicative of the product’s manufacturer. A third of respondents (32%) had no opinion.
The results of the naming survey showed that respondents were not in complete agreement on how biological medicines, whether originators or biosimilars, should be named. The data presented here provide important feedback from a wide range of physicians who prescribe biologicals in the US.
In a separate study, the ASBM invited 9,813 prescribers to complete a study on the labelling of biologicals, 624 of these responded, of which 400 qualified and completed the study [1]. Physicians who completed the study were asked what information they would like to see in a biological product label to help them choose between multiple biosimilars and their reference products. Physicians were asked what information could be included in a label, such as what clinical data should be present; whether or not the product was a biosimilar; and whether or not it was interchangeable. Product labelling is seen at the heart of building user confidence in biosimilars [7].
On a scale of 1–5, where 1 is not important at all and 5 is very important, 90% of the physicians questioned rated the importance of whether a product label for a biosimilar should clearly indicate that it is a biosimilar as either a 4 or 5. On the question of post-marketing data, 79% of respondents rated the importance of including this data on the biosimilar label as either a 4 or 5. On the question of interchangeability, 79% of respondents rated the importance of including whether or not a biosimilar is interchangeable as either a 4 or 5.
Segment differences were examined for all issues included in the survey. Segments among physicians included specialty, time spent working in health care, and practice setting. Very few specialty differences were noted and no differences for practice setting were noted. In general, the longer a physician had been in practice, the more important they thought it was to include the features mentioned in the survey on the biosimilar product label.
It is clear, from the data collected here, that a number of physicians have not reached a consensus on the issues involved, and further discussion and education is needed.
Key points of the 2015 physicians naming and labelling surveys
• All items queried in the labelling survey were considered very important for label inclusion.
• The fact that a drug was a biosimilar was considered the most important; whether or not it was interchangeable was slightly less important.
• In general, the longer a physician has been practising, the more important they considered the inclusion of post-marketing data and a clear distinction between data generated by the biosimilar sponsor and by the originator sponsor.
• 66% of physicians thought FDA should require a distinct non-proprietary scientific name for every biological product – whether originator or biosimilar – that FDA had approved. 11% of physicians did not, and 23% of physicians had no opinion.
• 60% of physicians would prefer a suffix on the non-proprietary name that is indicative of the product’s manufacturer. 32% of physicians had no opinion. Only 9% of physicians thought a random suffix that does not indicate the manufacturer – as recently required by FDA – would be best.
• 35% of respondents considered it very important they had the authority to designate a biological medicine as ‘dispense as written’ or ‘do not substitute’. Nearly all respondents considered it important and only 2% of respondents thought it was not at all important.
Related article
US pharmacists’ views on the naming and labelling of biologicals
References
1. Gewanter HL, Reilly MS. Naming and labelling of biologicals – a survey of US physicians’ perspectives. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):7-12. doi:10.5639/gabij.2017.0601.003
2. Cohen JP, Felix AE, Riggs K. Gupta A. Barriers to market uptake of biosimilars in the US. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):108-15. doi:10.5639/gabij.2014.0303.028
3. O Dolinar R, Reilly MS. Biosimilars naming, label transparency and authority of choice – survey findings among European physicians. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(2):58-62. doi:10.5639/gabij.2014.0302.018
4. Feijó Azevedo V, Mysler E, Aceituno Álvarez A, Hughes J, Flores-Murrieta FJ, Ruiz de Castilla EM. Recommendations for the regulation of biosimilars and their implementation in Latin America. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3): 143-8. doi:10.5639/gabij.2014.0303.032
5. Abas A, Khoo YSK. Regulation of biologicals in Malaysia. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(4):193-8. doi:10.5639/gabij.2014.0304.044
6. GaBI Online - Generics and Biosimilars Initiative FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 14]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
7. European Biopharmaceutical Enterprises. Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(4):188-92. doi:10.5639/gabij.2014.0304.043
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