Last Year's Physician Survey: Barriers to Understanding Biosimilars

Stanton R. Mehr

Survey shows education will be needed to convince physicians of the value of biosimilar agents.

A new survey of US specialists who may be high prescribers of biosimilars in the future shows that education will be needed to convince them of the value of biosimilar agents. The survey (conducted from November 20, 2015, to January 4, 2016) had responses from 1200 US dermatologists, gastroenterologists, nephrologists, oncologists, and rheumatologists. It is meant to be repeated in 2 to 3 years and serves as a baseline snapshot of these physicians’ understanding and attitudes toward biosimilars. At the time the survey was conducted, only Zarxio was approved for use by the FDA.

Sponsored by the Biosimilars Forum, the survey revealed 5 major knowledge gaps. There were shortcomings both in how terms were defined and in the approval process. Although more than 75% of the surveyed physicians had heard the term “biosimilars” used, at the time the research was conducted, they questioned how extrapolation of indications was decided by FDA, had limited knowledge about the interchangeability designation, and did not understand whether biosimilars were expected to have the same safety profile as that of the originator medication. The results of the Biosimilars Forum physician survey were published in Advances in Therapy.

Only 12% of those responding to the survey indicated that they trusted the extrapolation process. When asked to identify which products that they regularly prescribe within their specialty, only 69% of hematologists and 63% of medical oncologists correctly identified which of these medications were biologics. In comparison, over 90% of gastroenterologists and dermatologists correctly distinguished the biologic agents.

For example, survey questions revealed that most physicians surveyed do not clearly understand the concept of extrapolation as it applies to biosimilars, with only 12% of survey respondents stating that they trust extrapolation of the studied biosimilar indication(s) as the basis to obtain approval of other licensed indications of the originator product. Only 45% of these specialists believed at the time of the survey that biosimilars will be safe and appropriate for use in naïve and existing patients. However, approximately 60% of the specialists surveyed understood that an "interchangeable" biosimilar must be shown to be safe and effective through a series of switches from reference to biosimilar and back again. Yet, 91% agreed with the statement that switching an existing patient to a biosimilar may be appropriate if it would help the patient have better access to his/her medications.

Again, as this was a baseline survey, it would be reasonable to assume that the torrent of articles and education available in the last 12 months has significantly altered these responses. The Biosimilars Forum intends to conduct a similar survey in 2 to 3 years in order to monitor trends in the awareness, knowledge, and perceptions of biosimilars over time.

Coincidentally, the results of a similar European follow-up study was just published in the Journal of Crohn’s and Colitis. Italian and Swiss investigators demonstrated gastroenterologists’ improved comfort levels and knowledge about biosimilars from 2013 to 2016. In the initial 2013 investigation (2 years before their availability in the European Union [EU]), confidence levels and knowledge about biosimilars were found to be low. In the latest survey (with 118 physicians treating inflammatory bowel disease [IBD] responding), conducted 1 year after the introduction of the biosimilar infliximab in Europe, the awareness and confidence levels of IBD specialists were vastly improved. In fact, roughly one-third now believe distinct nonproprietary names are needed for these biosimilars, as opposed to two-thirds in the first survey. According to these respondents, 44% believe the originator and biosimilar agent are interchangeable in practice compared with only 6% in the 2013 survey. In addition, the potential for immunogenicity still tops concern (69%) in the latest results, with less than one-fifth having little or no confidence in the prescription of biosimilars compared with two-thirds in 2013.

Although these results really apply only directly to infliximab, as this was the only biosimilar approved to treat IBD in the EU at the time of the study, it does indicate the path to physician confidence and uptake must be paved with education and practice experience with the agent.