Real-world familiarity with US biosimilar regulatory guidelines and interchangeability state laws among pharmacists and physicians treating immunological disorders.

Abstract

Background: The US Food and Drug Administration (FDA) considers an interchangeable biosimilar to produce the same clinical result as the reference product in any given patient. Interchangeability standards indicate that the biosimilar can be automatically substituted by pharmacists for the reference product without the intervention of the prescribing health care provider, where state law permits. More research is needed to describe pharmacists' and physicians' perceptions and experience with biosimilars in real-world settings for immunological disorders.

Objective: To assess US providers' perceptions and decision-making around the prescribing and dispensing of biosimilars, including those with an interchangeability designation.

Methods: US outpatient pharmacists and physicians who prescribe biologics for dermatological, gastroenterological, rheumatological, or other immunological disorders responded to a cross-sectional electronic survey. Respondents reported data on professional characteristics, pharmacy characteristics, familiarity with regulatory guidelines, workflow relevant to treatment substitutions, and perceived barriers to navigating the interchangeability designation and dispensing interchangeable biosimilars. Data were aggregated and summarized descriptively.

Results: One hundred fifty physicians and 99 pharmacists (total n = 249) from diverse practice settings responded to the survey. Continuing education units related to biosimilars were obtained by 65.7% of pharmacists and 50.7% of physicians. A higher percentage of pharmacists (35.4%) than physicians (20.0%) reported themselves as "extremely familiar" with pharmacy retention of communication records. A greater proportion of pharmacists (47.5%) than physicians (31.3%) were "extremely likely" to recommend a biosimilar product to new start patients (ie, never treated with a reference biologic and/or biosimilar). Among all providers, the barriers to biosimilars most often perceived to be "extremely significant" were payer coverage/formulary placement (51.0%) and cost to the patient (41.0%). The strategies that were reported as the highest likelihood of improving the uptake of interchangeable biosimilars (reported as either "likely" or -"extremely likely") were as follows: conducting studies and developing educational programs that assess outcomes of biosimilars and biosimilars with an interchangeability designation in clinical practice (82.3%), FDA guidance on biosimilars with an interchangeability designation for treatment-naive patients (81.9%), FDA guidance on biosimilars with an interchangeability designation for switching patients (81.6%), and educational programs on billing and reimbursement (79.1%).

Conclusions: Pharmacists reported higher rates of familiarity and training with biosimilars and recommendation of biosimilars to patients than physicians. A diverse sample of physicians and pharmacists expressed perceived barriers and strategies to improve biosimilars uptake, including educational programs and FDA guidance. Further research is needed to determine if providers' perceptions of biosimilars are associated with biosimilars uptake.