Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians

Abstract

Introduction: The Biosimilars Forum conducted a survey through an independent organization from November 20, 2015 to January 4, 2016 in order to assess current levels of awareness, knowledge, and perceptions of biosimilars among US specialty physicians who already prescribe biologics. The survey was intended to provide a baseline level of knowledge about biosimilars and will be repeated in 2-3 years in order to monitor trends over time.

Methods: A 19-question survey was created by the Biosimilars Forum and was administered by an independent third party.

Results: Responses were obtained from 1201 US physicians across specialties that are high prescribers of biologics, including dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists, and rheumatologists.

Conclusions: The results of this survey highlight a significant need for evidence-based education about biosimilars for physicians across specialties. Five major knowledge gaps were identified: defining biologics, biosimilars, and biosimilarity; understanding the approval process and the use of "totality of evidence" to evaluate biosimilars; understanding that the safety and immunogenicity of a biosimilar are comparable to the originator biologic; understanding the rationale for extrapolation of indications; and defining interchangeability and the related rules regarding pharmacy-level substitution.

Funding: Biosimilars Forum.

Keywords: Biologic; Biosimilar; Biosimilarity; Extrapolation; Immunogenicity; Interchangeability; Originator biologic.

Fig. 1

Physicians were provided with a list of drugs used by their specialty, only some of which were biological drugs. They were asked to identify whether each drug was a biologic and were also given the option of selecting “None of the above” or “I do not know”. (Bars represent the mean, with ranges provided vertically)

Fig. 2

Respondents were asked how long have biosimilars been available in the US. The correct answer is encircled

Fig. 3

Respondents were asked what criteria they believe FDA will use to approve a biosimilar. There are three correct responses to this question: “Data from at least one clinical study in a patient population that is sensitive to detect differences;” “A comparison of PK/PD data for the biosimilar and its originator counterpart;” and “A comparison of analytical characteristics between the biosimilar and its originator brand counterpart”

Fig. 4

Respondents were asked which of the following statements are true when the FDA approves a biosimilar. Choices A and B are correct

Fig. 5

Respondents were asked if they believe biosimilars will be safe and appropriate for use in naïve and existing patients

Fig. 6

Respondents were asked if it would be essential for doctors to have data directly evaluating the safety of switching patients from an originator biologic to its biosimilar

Fig. 7

Respondents were asked if they believe a biosimilar will be less safe than its originator biologic because it will be approved through an abbreviated pathway

Fig. 8

Respondents were asked to rate their level of agreement with the following statement: “With originator biologic medicines, I have concerns about my patients’ compliance and/or access to treatment options”

Fig. 9

Respondents were asked which biosimilars topics they were most interested in learning more about