A survey of 1,201 U.S. physicians published in Advances in Therapy found that most health-care professionals trust the safety and efficacy of biosimilar agents – and the U.S. Food and Drug Administration’s (FDA) decisions regarding them – but that physicians may lack knowledge in a few key areas regarding their use.
Hillel Cohen, PhD, and authors distributed a 19-question survey that was created by the Biosimilars Forum and conducted by SERMO – a global network organization for physicians – between November 20, 2015, and January 4, 2016.
Responses were collected from physicians across specialties, including hematology/oncology, dermatology, gastroenterology, medical oncology, nephrology, and rheumatology.
The survey identified five knowledge gaps common among the respondents:
- not being able to define biologics, biosimilars, or biosimilarity
- not understanding how the FDA uses a “totality of evidence” to approve biosimilars
- not believing the biosimilar is as safe as the originator
- an inability to understand how the FDA extrapolates indications
- an inability to define interchangeability or certain substitution rules
Other highlights of the survey’s findings:
- 3% and 57.2% knew that the FDA must find a biosimilar to be equally effective and safe, respectively, as the original product.
- 5% said they trust the FDA’s biosimilar approval decisions.
- Nearly 60% understood a biosimilar must be shown to be as safe and effective during back-and-forth switching in order to be approved as interchangeable.
- Nearly 80% did not realize the FDA designation “interchangeable” allows a pharmacist to switch between the originator and biologic.
- 8% believed that biosimilars are safe and appropriate for use in pre-treated and treatment-naïve patients.
- 91% said they would consider switching a patient from a biologic to a biosimilar if it would help the patient have better access to medications.
“With four biosimilars approved by the FDA and more than 60 in development, the survey highlights the need for greater biosimilars education for physicians and health-care professionals,” the authors wrote.
The Biosimilars Forum plans to conduct a similar survey in two to three years to monitor trends in the awareness, knowledge, and perceptions of biosimilars.
Source: Cohen H, Beydoun D, Chien D, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. Adv Ther. 2017;33:2160-72.