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Biosimilar survey finds knowledge gaps among specialists
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According to a press release from the Biosimilars Forum, a recently published biosimilar survey administered to specialists in the United States found five knowledge gaps.
The gaps included the following: 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; and an inability to define interchangeability or certain substitution rules.
“With four biosimilars approved by the FDA and more than 60 in development, the survey highlights the need for greater biosimilar education of physicians and health care professionals,” Hillel Cohen, PhD, lead author and executive director of Scientific Affairs at Sandoz Inc., said in the release. “Education will help physicians and health care professionals have a better understanding of biosimilars, so that they feel comfortable about administering biosimilars to patients when appropriate.”
Between November 2015 and January 2016, researchers from the Biosimilars Forum designed a 19-question survey that was administered to 1,201 specialists who prescribed biologics. The group included dermatologists, gastroenterologists, hematologists, oncologists, medical oncologists, nephrologists and rheumatologists.
The researchers found 76.8% of physicians knew the term biosimilar. However, according to the release, 12% trusted the FDA’s “extrapolation of indications” as basis for approval of the other originator indications. While 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, almost 80% did not realize the FDA designation “interchangeable” allows a pharmacist to switch between the originator and biologic. In addition, 62.3% knew the FDA must find a biosimilar to be equally effective and 57.2% knew the FDA deemed these to be equally safe. Moreover, 44.8% believed biosimilars were safe to use. Despite this, 74.5% trusted the FDA’s biosimilar approval decisions. Overall, 91% would consider switching from an originator to a biosimilar if it gave the patient better access to medication. Further, 82.2% believed biosimilars would lower medical costs for patients.
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Disclosures: Cohen reports he is an employee for Sandoz Inc. and owns stock in Novartis Corp. Please see the full study for a list of all other relevant financial disclosures.
Perspective
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Jonathan Kay, MD
Since the first biosimilar became available in the United States in September 2015, practicing physicians have become increasingly interested in issues surrounding the development, regulatory review and clinical use of biosimilars. This study, written by employees of several companies that are developing biosimilars, describes the results of a survey they created to assess practicing physicians’ current understanding of biosimilars.
The survey was completed by 1,201 physicians in the United States and was distributed among those subspecialties that prescribe biological agents. These physicians were chosen for being “high prescribers of biologics.” They were questioned about a variety of topics relevant to the development and regulatory review of biosimilars.
More than half of the respondents were concerned that approved biosimilars might not be as safe or effective as their reference drugs. Many expressed concern about the safety of transitioning patients from a bio-originator to a biosimilar. Few were comfortable with the concept of extrapolating data about a biosimilar from one indication to another, for which the bio-originator already is approved. Although the numbers of physicians surveyed in each specialty were small, rheumatologists appeared least comfortable and hematologist-oncologists seemed most comfortable with issues regarding biosimilars, likely reflecting their relative experience using biosimilars in clinical practice.
This study confirms the unmet need among practicing physicians for education about biosimilars. Now that four biosimilars have been approved in the United States and more are in development, it will be important to provide health care professionals with opportunities to receive objective and unbiased information about biosimilars so they can treat patients appropriately with cost-effective and safe medications.
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