2 Surveys Highlight Rheumatologists' Knowledge Gaps With Biosimilars

Two posters presented today at the American College of Rheumatology’s 2017 meeting in San Diego, California, highlight the gaps in US rheumatologists’ knowledge concerning biosimilar therapies, and underscore the importance of greater physician education about biosimilar medicines.

The first poster¹ presented results of a survey, conducted by Allan Gibofsky, MD, and Sam Badawi, PharmD, that was developed to evaluate US rheumatologists’ familiarity with biosimilars. Areas of consideration included the concept of biosimilarity and the approval pathway for biosimilars.

The researchers administered a 20-question survey, using WebMD, between December 9-14, 2016. Respondents (n = 131) were members of Medscape.com, and had been invited via e-mail to participate in the survey. Data were collected from 102 participants who identified themselves as rheumatologists who had practiced in the United States for 1 year or longer. All but 1 respondent had prescribed an anti—tumor necrosis factor (anti-TNF) agent to treat a patient with an autoimmune disease.

When the physicians were asked to identify the status of biosimilars in the United States as of December 2016, 84% of respondents were aware that an infliximab had been approved by the FDA. However, only 47% were aware that the FDA had approved an adalimumab biosimilar, and only 34% were aware that the FDA had approved an etanercept biosimilar.

Most physicians had extreme (38%) or moderate (36%) familiarity with the FDA’s definition of a biosimilar, and most (71%) were aware that a biosimilar that gained FDA approval was not automatically deemed interchangeable.

Respondents also ranked the following as very important or moderately important:

• Designation of interchangeability (74%)
• Effectiveness (96%)
• Safety (96%)
• Durability of response (95%)

With respect to initiating treatment, 66% were extremely likely or likely to initiate treatment with a biosimilar in treatment-naïve patients with rheumatoid arthritis if the approval of the biosimilar included efficacy and safety studies in the same indication, while fewer were extremely likely (5%) or likely (29%) to do so if the approval was based on data obtained from studies in another rheumatologic indication.

Approximately 60% of respondents were unlikely to switch from a reference biologic to a biosimilar in patients who were responding well to their current therapy. Additionally, 21% of respondents were extremely likely or likely to switch to a biosimilar if the patient was failing to respond well to the originator.

The researchers concluded that the results of this survey support a need to further educate US rheumatologists about biosimilars, the extrapolation of indications, and interchangeability, and that physicians have knowledge gaps that range from an understanding of the concept of biosimilarity to the availability of approved biosimilar therapies.

The second poster² presented the findings of Janna Radtchenko, MBA, and colleagues, who conducted a survey of 24 community rheumatologists and 20 rheumatology practice managers during a live meeting in April 2017. The respondents represented practices of various sizes and geographic locations across the United States. The researchers, gathering data with the use of audience response technology, found the following:

• 51% of respondents understood the concept of interchangeability
• 76% were unaware of compatibility requirements for reference products following a manufacturing change
• 40% believed that biosimilars had equivalent safety and efficacy to their references
• 20% would not prescribe a biosimilar
• 23% would be willing to switch a patient to a biosimilar from its reference
• 57% would prescribe a biosimilar to a new patient

Responses to the question “Which issues are most concerning?” included the following, in descending order of frequency:

• Regulations related to substitution
• Understanding when to prescribe a biosimilar versus a reference
• Coordinating with pharmacists on substitution

Respondents named information about safety and efficacy, guidelines on when to prescribe a reference versus a biosimilar, and information about reimbursement as key tools for achieving a greater understanding of biosimilars.

The researchers concluded that physicians’ perceptions of biosimilars for rheumatologic indications present a significant barrier for the adoption of biosimilars, and that greater education may improve perceptions and facilitate more biosimilar usage.

References

1. Gibofsky A, Badawi S. Biosimilar knowledge among US rheumatologists—a survey. Presented at the American College of Rheumatology 2017 meeting, November 6, 2017; San Diego, California. Abstract 1037. acrabstracts.org/abstract/biosimilar-knowledge-among-us-rheumatologists-a-survey/.

2. Radtchenko J, Smith Y, Kish J, Feinberg B. Perceptions of US community rheumatologists on biosimilars. Presented at the American College of Rheumatology 2017 meeting, November 6, 2017; San Diego, California. Abstract 1040. acrabstracts.org/abstract/perceptions-of-us-community-rheumatologists-on-biosimilars/.