Can biosimilar manufacturers learn from generic substitution issues

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Can biosimilar manufacturers learn from generic substitution issues

Biosimilares/Investigación | Posted 04/11/2011 0 Post your comment

The substitution of generic prescription medicines for branded medicines is practiced in most Westernised countries, mainly because of its clear economic benefits. Patient experiences of generic substitution are mixed however, with many patients left confused or suspicious [1]. Given that a number of second-generation biosimilar compounds are expected to be approved within the next few years, and that biosimilar manufacturing costs are much higher than those of a simple generic, it is crucial for biosimilar manufacturers to avoid the uncertainty and mistrust that often accompanies generic substitution. Several recommendations have been made to help ensure that substitution pathways are streamlined and successful [1] but can any of these recommendations be applied to biosimilars?

Most generics are dispensed in a primary care or community environment, a prescription is written by a general practitioner and the drug is dispensed by a community pharmacist. Whenever a branded prescription is substituted for a generic version however, several issues can arise. An international study by Gill et al investigated the generic substitution experiences of 15 pharmacists and 30 customers [1]. The investigators found that if the patient had a low awareness of the substituted generic, they were likely to become confused or suspicious. Anecdotal patient feedback included the following:

‘Why don’t doctors and pharmacists get together to figure out the best medicine for me—why do I need to go through this fuss?’

‘I was still not quite sure (about the generic medicine) so the next time I met my doctor; I asked him if the medicine I took was OK.’

‘The pharmacist just kept telling me that the generic medicine was the same. But I know it’s not the same. I became irritated that the pharmacist could not admit that they are not the same.’

‘There must be some advantages for pharmacists (in offering generics). Some of them are so insistent.’

‘The Department of Health should distribute free brochures to inform on generics advantages and disadvantages. They should also create a website.’

‘There should be more intense cooperation between doctors and pharmacists. They should speak the same language.’

The investigators concluded that if generic substitution was required, open dialogue between all participants of the service network was paramount. They added that the development of targeted promotional materials, i.e. educational materials, was also crucial [1].

Unlike the generic examples cited above, most biosimilars are dispensed in hospital, delivered via healthcare professional administered injection. Because of this change in ‘end user’, i.e. the patient is the end user for an oral generic, whilst the physician is the end user for an injectable biosimilar; the emphasis changes from educating the patient to educating the physician. Ultimately, physicians and other practitioners must be confident in the data that shows that a biosimilar is highly similar to the reference product [2].

A National Comprehensive Cancer Network (NCCN) Trends Survey™ has reinforced the need for increased physician education. This survey was conducted from March 10-11, 2011 at the NCCN 16th Annual Conference in Hollywood, FL, USA and involved 277 respondents. Respondents consisted of physicians (n = 129), nurses (n = 71), pharmacists (n = 38), and other types of clinicians or non-practicing clinicians (n = 39). As part of the survey, participants were asked to provide their level of interest in prescribing, dispensing, or administering biosimilars [2].

The survey suggested that overall interest in prescribing, dispensing, or administering biosimilars was high, with 27% and 35% responding with high and moderate interest, respectively. However, 26% of respondents indicated that they required more information in order to make a decision regarding their future interest in using biosimilars. The implication was that more attention and education on biosimilars would increase clinician understanding and allow them to form opinions about using biosimilars in the future [2].

The response to the survey indicates that there is room for improving clinician knowledge regarding biosimilars and that improving this knowledge is vital. By understanding the scientific concepts behind biosimilars, clinicians will be well positioned to make clinical decisions that positively impact the patients whom they serve [2].

So despite having different administration pathways, it appears that the principal concept of generic substitution and biosimilar usage is identical: the education of the end user, whether it be the physician or patient, is essential. Biosimilar manufacturers should take heed.

Related articles

Interchangeability or substitution of biosimilars

The benefits of generic substitution

References

1. Gill L et al. How do customers and pharmacists experience generic substitution? Int J Pharmaceutical and Healthcare Marketing 2010; 4:375–95.

2. Li EC. Biosimilars: More education is needed [cited 2011 November 2011]. Available from: http://www.nccn.org/about/news/ebulletin/2011-04-18/biosimilars.asp