Background/Purpose:

Four biosimilar tumor necrosis factor α (TNFα) inhibitors have been approved by the FDA in the United States as of April 2017. This survey was developed to evaluate US rheumatologists’ familiarity with biosimilars, the concept of biosimilarity, and the approval process for biosimilars in the treatment of immune-mediated chronic diseases.

Methods:

A 20-question survey was administered by WebMD between December 9 and 14, 2016. Physicians (n=958) who were medscape.com members were invited to participate in an online survey via email. Most survey items used a 5-point Likert scale. Results were summarized descriptively.

Results:

Overall, 131 physicians responded, a response rate of 13.67%. Data were collected from 102 participants who were self-identified rheumatologists, practicing in the US for ≥1 year. All but 1 respondent had prescribed a TNFα monoclonal antibody (mAB) for the treatment of an autoimmune disease. When asked to choose the status of biosimilar development (as of December 2016), the majority (84%) of respondents were aware that an infliximab biosimilar was approved in the US, but only 47% and 34% were aware of the recent approvals of the adalimumab and etanercept biosimilars, respectively. Most physicians were extremely (38%) or moderately (36%) familiar with the FDA’s definition of a biosimilar. Most respondents (71%) were aware that an approved biosimilar was not automatically deemed interchangeable by the FDA. When asked to rate their expectations of biosimilar products, 74% indicated that an interchangeable designation was very or moderately important. Regarding other characteristics of the biosimilar compared with the originator, the majority indicated that effectiveness (96%), safety (96%), and durability of response (95%) were very or moderately important. Regarding treatment initiation, 66% of physicians were extremely likely or likely to initiate biosimilar treatment for a biologic treatment-naïve patient with RA if the approval included efficacy and safety studies in the same indication, whereas 5% and 29% were extremely likely or likely, respectively, to initiate biosimilar treatment for a biologic treatment-naïve patient with a different rheumatologic condition than the one on which the approval was based. Approximately 60% of survey respondents were unlikely to switch therapy from an originator to its biosimilar TNFα mAB in patients who were doing well, regardless of whether the patient had the same or a different rheumatologic indication than the one on which the biosimilar approval was based. Also, 21% of respondents were extremely likely or likely to switch to a biosimilar if the patient was failing on the originator.

Conclusion:

This survey supports a need to further educate US rheumatologists about biosimilars, extrapolation, and interchangeability. Knowledge gaps include a lack of understanding of biosimilarity based on switching, and the availability of currently approved biosimilars.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/biosimilar-knowledge-among-us-rheumatologists-a-survey/