Physicians Want Strong FDA Biosimilar Naming


80 percent of physicians preferred a meaningful, distinguishable suffix
WASHINGTON, DC – The Biologics Prescribers Collaborative, a project of the Alliance for Patient Access, released new findings from a poll of physicians conducted about the FDA’s proposed biosimilar naming guidelines. According to a SERMO poll representing physicians across multiple specialties, overwhelmingly, 80 percent of physicians preferred a meaningful four-letter suffix that noted the biosimilar manufacturer’s name, versus a random four-letter suffix. Only 8 percent of physicians preferred a suffix devoid of meaning while 12 percent had no preference.
More than half of physicians, 53 percent, said they would feel more confident prescribing a biosimilar if the product contained a meaningful suffix. Seven percent said they would feel more confident with a suffix devoid of meaning while 39 percent said it would have no impact on their confidence prescribing biosimilar products.
More than 2/3 of physicians were also interested in learning more about biosimilar clinical trial data.
The survey was conducted by SERMO, the largest global social network exclusively for doctors, October 11 and 12 with a sample size of 509. Rheumatologists and oncologists each accounted for 18 percent of respondents, with gastroenterologists at 17 percent, dermatologists and endocrinologists at 16 percent, and neurologists at 15 percent.

The medications’ four-letter suffixes, also known as “biological qualifiers,” differentiate their nonproprietary names, allowing physicians to accurately determine which biological medication a patient takes and to address any problems that might impact patient safety.

The FDA has not yet issued final guidance on naming conventions, despite continuing to approve applications for biosimilar medications. The agency has at different points in time endorsed both random and memorable suffix systems.

Originally, the FDA opted for a memorable suffix as a “placeholder” when approving the United States’ first biosimilar. The drug carries the name “filgrastim-sndz,” where the suffix “sndz” reflects the medication’s manufacturer, Sandoz. Nearly six months later, however, the agency released draft guidance indicating that it might deviate from its earlier approach and use randomly generated suffixes. In the biosimilar drug approvals that have followed, each has been assigned a random suffix.

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