Biosimilars: More Education Is Needed
By Edward C. Li, PharmD, BCOP, Drugs and Biologics Editor
As the use of biologics in the active treatment of cancer and for supportive care management increases, the issue of biosimilars (i.e., “generic” biologics) becomes more relevant to the clinical practitioner. In an editorial recently published in JNCCN Special Issue: NCCN Oncology Pharmacy and Policy, a discussion regarding the recent legislation establishing a biosimilars pathway and subsequent issues surrounding biosimilars was presented. A key point raised is that clinicians should be familiar with the concept of biosimilars from the scientific standpoint so that they can subsequently assess and evaluate individual biosimilar agents and determine the utility of these agents in their own patient populations. Ultimately, physicians and other practitioners must be confident in the data that shows that a biosimilar is highly similar to the reference product.
A recent NCCN Trends Survey™ suggests that familiarity with biosimilars is suboptimal and that more clinician education is required. This NCCN Trends Survey™ was conducted from March 10-11, 2011 at the NCCN 16th Annual Conference in Hollywood, FL. With more than 1,400 conference attendees, a convenience sample of 277 people responded to the survey. Respondents consisted of physicians (n = 129), nurses (n = 71), pharmacists (n = 38), and other types of clinicians or non-practicing clinicians (n = 39). Two questions in the survey asked participants to rate their familiarity with recent legislation regarding biosimilars and to provide their level of interest in prescribing, dispensing, or administering biosimilars.
As depicted in Figure 1, more than half of respondents were either not at all familiar (36%) or slightly familiar (19%) with recent developments regarding biosimilars. A minority of respondents were extremely familiar with the recent developments (7%). Overall interest in prescribing, dispensing, or administering biosimilars appeared high, with 27% and 35% responding with high and moderate interest, respectively (Figure 2). However, approximately one-fourth of respondents indicated that they require more information in order to make a decision regarding their future interest in using biosimilars. Not surprisingly, 61% of those who responded that they were “not at all familiar” with biosimilars also responded that they are currently unable to rate their interest with using biosimilars because they need more information about the topic. Still, about 25% of those who responded with at least moderate familiarity of biosimilars also stated that they are currently unable to rate their interest with using biosimilars because they need more information. This is potentially due to the novelty of this concept in the United States, and thus more attention and education on biosimilars may increase clinician understanding and allow them to form opinions about using biosimilars in the future.
Overall, the responses to these two survey questions indicate that there is room for improving clinician knowledge regarding biosimilars. Improving this knowledge is important given that the future approval of biosimilar agents will likely influence how clinicians prescribe, dispense, and administer biologics for patients with cancer. Introducing biosimilars into clinical practice may increase the affordability of, and therefore access to, expensive therapies typically used in the course of cancer treatment. By understanding the scientific concepts behind biosimilars, clinicians will be well positioned to make clinical decisions that positively impact the patients whom they serve.
Figure 1. Respondents were asked to rate their overall familiarity with developments for biosimilars, including recent legislation that provides an approval pathway for non-innovator (e.g. “generic”) manufacturers to introduce copies of biologics through an abbreviated review process (n = 277).
Figure 2. Respondents were asked to rate their interest in prescribing, dispensing, or administering biosimilars in their practice setting if approved by the FDA (n = 277).
Biosimilars: More Education Is Needed
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