WASHINGTON — Though the vast majority of specialty physicians know what biosimilars are, their knowledge about these emerging medications falls short, according to a survey by the Biosimilars Forum.
Of 1,201 U.S. physicians polled, 76.8% had heard the term biosimilars within the previous month, the Biosimilars Forum said Tuesday. Yet respondents exhibited five key gaps in knowledge: defining biologics, biosimilars and biosimilarity; understanding the biosimilar approval process and the Food and Drug Administration’s use of totality of evidence to assess biosimilars; appreciation that biosimilars’ safety profile is expected to be the same as that of the originator biologic; understanding how the FDA makes decisions for extrapolation of indications; and defining interchangeability and the related rules regarding pharmacy-level substitution.
Nearly 60% of doctors correctly understood that to be approved as interchangeable, a biosimilar must be shown to be safe and effective for back-and-forth switching, with no negative impacts to safety or efficacy, the survey found. However, almost 80% didn’t agree — or potentially didn’t realize — that an FDA designation of interchangeable may allow a pharmacist to switch between the originator biologic and biosimilar and vice versa.
A little more than half of physicians polled know that, to be approved, the FDA must find a biosimilar to be equally effective (62.3%) and safe (57.2%) when compared with the originator biologic. Fewer than half of respondents (44.8%) think biosimilars will be safe and appropriate for use in existing patients as well as naïve patients.
Most physicians surveyed don’t clearly understand the concept of extrapolation as applied to biosimilars, with just 12% of respondents stating that they trust extrapolation of the studied biosimilar indication(s) as the basis to obtain approval of other licensed indications of the originator product, according to the study.
Physicians surveyed were from specialties that are high prescribers of biologics, including dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists and rheumatologists. The 19-question poll, created by the Biosimilars Forum, was conducted by SERMO, a global social network organization for physicians. The results of the survey were posted online Monday by the journal Advances in Therapy and presented at the Drug Information Association Biosimilars 2016 conference in Washington, D.C.
“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,” lead study author Hillel Cohen, executive director of scientific affairs at Sandoz Inc., said in a statement. “Education will help physicians and health care professionals have a better understanding and knowledge of biosimilars so that they feel comfortable about administering biosimilars to patients when appropriate.”
About three-quarters (74.5%) of doctors reported that they trust the FDA’s biosimilar approval decisions, the study found. Ninety-one percent said they would consider switching a patient from an originator biologic to a biosimilar if it would help the patient have better access to his or her medications. In addition, 82.2% believe biosimilars will expand treatment options and provide savings to patients and the health care system.
“The Biosimilars Forum launched the Partnership for Biosimilar Education and Access to provide evidence-based education for health care professionals, patients and the public,” Cohen added. “The forum will use the survey results to provide education on the key concepts of biosimilars, as we advance our mission to encourage awareness, access and adoption of these important medicines.”
The nonprofit Biosimilars Forum aims to advance biosimilars in the United States to expand the access and availability of biological medicines. Its founding members represent the majority of companies with the most significant U.S. biosimilars development portfolios, including Allergan, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Merck, Pfizer, Samsung Bioepis, Sandoz and Teva.