Rheumatologists' Biosimilar Awareness Is Growing, But Their Confidence Has Room to Improve

Among the most important stakeholder groups contributing to biosimilar uptake are prescribers, particularly in the US context in which interchangeable biosimilars are not yet a reality that can allow for automatic substitution at the pharmacy counter.

Over the past few years, awareness of biosimilars has been increasing; however, research presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, shows that while US rheumatologists hold growing awareness of biosimilars, hesitancy remains around such issues as switching stable patients and the extrapolation of indications.

On Sunday, a research team reported on an ongoing survey of rheumatologists that has been, for multiple years, assessing the attitudes of clinicians who prescribe biologics that treat rheumatic diseases.¹ The researchers used a 19-question online survey, administered by WebMD in May of 2019, to gather responses from 291 US rheumatologists.

Most respondents reported familiarity with biosimilars; 82% said they were very or extremely familiar with these agents, and 16% said they were moderately familiar. However, while 97% of respondents were aware that infliximab biosimilars are FDA approved, fewer were aware of FDA approvals of adalimumab biosimilars (57%), etanercept biosimilars (62%), and rituximab biosimilars (40%). Most (84%) were aware that biosimilars are not automatically granted interchangeable designations by the FDA, and 85% said it was important or very important for the interchangeable approval to be on a biosimilar’s label.

Rheumatologist were more willing (72%) to initiate a biosimilar for a biologic-naïve patient than they were (33%) to switch a patient who is doing well on the reference drug. Approximately half of respondents said they had patients for whom a switch to a biosimilar had been recommended, and insurance or formulary coverage (80%) was the main driver for such suggestions, followed by hospital formularies (68%) and step therapy requirements (63%).

According to the authors, US rheumatologists’ understanding of biosimilars is increasing, and acceptance—particularly with respect to treating biologic-naïve patients—is also increasing, though physicians remain hesitant to switch patients who are already stable on biologic therapy.

On Monday, a second research team reported on another survey, conducted in a live meeting in November 2018, among 54 US rheumatologists.² Among the respondents, most of whom practiced in urban (48%) or suburban (45%) locations, 67% had prescribed a biosimilar since 2016.

In terms of familiarity with biosimilars and the FDA’s approval pathway for these drugs, 34% said they were very familiar, 56% said they were somewhat familiar, and 10% were unfamiliar.

In total, just 15% said that they were comfortable with current biosimilar safety and efficacy data, and 53% indicated that they would not prescribe a biosimilar without data for a specific indication. Regarding real-world evidence, 58% said that such additional data could suffice for an extrapolated indication, but 23% said they would only accept data from randomized controlled trials.

In terms of prescribing a biosimilar, respondents indicated that they would be most likely to use a biosimilar if it provides cost saving to the patient or the practice, and 48% said they would have to see a discount of 31% to 50% to give them enough incentive to consider a biosimilar over a reference.

Most rheumatologists are familiar with biosimilars, say the authors, and they are open to prescribing them, but cost savings and additional data appear to be important for expanded use.

References

1. Gibofsky A, McCabe D, Badawi S. US rheumatologists’ beliefs and knowledge about biosimilars—an ongoing survey. Presented at: The American College of Rheumatology Annual Meeting, November 8-13, 2019; Atlanta, Georgia. Abstract 549.

2. Yeh TC, Jeune-Smith Y, Phillips E, Gajra A, Feinberg B. US community rheumatologists’ knowledge and perceptions of biosimilar expanded indication approval by extrapolation. Presented at: The American College of Rheumatology Annual Meeting, November 8-13, 2019; Atlanta, Georgia. Abstract 1118.