Background/Purpose: Biosimilars contain a highly similar version of the active substance of an already approved biologic or “reference product.”¹ Regulatory agencies mandate that safety, efficacy, dosing, route of administration, and immunogenicity are established. The FDA allows extrapolation of safety and efficacy data from one biosimilar indication to another significantly lowering drug development cost. Biosimilars are thereby expected to have a lower price point than their reference product and result in reduced healthcare spending, but that will largely depend on how providers perceive and prescribe them. As of May 2017, four biosimilars have been FDA approved for rheumatologic conditions. We have evaluated the perceptions of U.S. community rheumatologists to identify areas of opportunity to support biosimilar adoption

Methods: Using audience response technology, we surveyed 24 community rheumatologists and 20 rheumatology practice managers (PMs) during a live meeting in April 2017. Participating physicians and PMs represented various practice sizes and geographic locations throughout the U.S.

Results: Regarding the legal and regulatory aspect of biosimilars and their reference biologics: only 51% of the respondents understood the concept of interchangeability between biosimilars and reference biologic; 76% were unaware of compatibility requirements for reference biologics following a manufacturing change; while only 40% believed biosimilars match the safety and efficacy of their reference biologics. When asked if they or their practice would prescribe a biosimilar approved for anti-rheumatic treatment: 20% would not prescribe at all, only 23% would switch a patient from the reference biologic, and 57% responded that they would prescribe it to patients initiating biologic therapy. The responses to the query, “Which issues are most concerning?” in descending order are: Regulations related to substitutions, understanding when to prescribe a biosimilar versus a reference biologic, and coordinating with pharmacists on substitutions. Information about safety and efficacy, guidelines on when to prescribe a reference biologic versus a biosimilar, and reimbursement information were named as tools for achieving a greater understanding of biosimilars.

Conclusion: Significant barriers to biosimilar adoption for rheumatologic conditions exist due to physicians’ perceptions. Education around biosimilar efficacy, safety, appropriate use, and reimbursement may improve perceptions and facilitate usage.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/perceptions-of-us-community-rheumatologists-on-biosimilars/