Physicians Align on Meaningful Biosimilar Suffixes
November 16, 2016
The Food and Drug Administration may not have reached consensus on the suffixes that distinguish biological and biosimilar medications, but physicians are of one mind: Meaningful suffixes matter.
New findings from the Biologics Prescribers Collaborative reveal that 80 percent of physicians would prefer meaningful suffixes that represent the drug manufacturer’s name. More than half of physicians, 53 percent, also said they would feel more confident prescribing a biosimilar if the product carried a meaningful suffix.
The four-letter suffixes, also known as “biological qualifiers,” differentiate biologics and biosimilars’ nonproprietary names. This allows physicians to accurately determine which biological medication a patient takes and to address any problems that might impact patient safety.
The FDA 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Nearly six months later, however, the agency released draft guidance indicating that it might deviate from its earlier approach and use randomly generated suffixes.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 medication has been assigned a random suffix.
The survey was conducted through SERMO, the largest global social network exclusively for doctors. Of the 509 physicians surveyed:
- 18 percent were rheumatologists and oncologists
- 17 percent were gastroenterologists
- 16 percent were dermatologists and endocrinologists
- 15 percent were neurologists.
The Biologics Prescribers Collaborative is an organization of physician groups whose members prescribe biologics.Tags: Biologics, Regulatory Issues
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