Clinical practice guidelines are intended to optimize patient care, explains a new policy brief from the Institute for Patient Access.
March 29, 2016
by Amanda Conschafter, blog editor
Two months have passed since the World Health Organization released its final proposal on naming biological and biosimilar medications. Yet physicians, patients and advocates in the United States continue to wait for the final word on naming from the Food and Drug Administration. Despite still having no official stance on naming, an FDA advisory committee recently voted to approve what will likely be the nation’s second biosimilar. The move intensifies the need for a final decision on naming to protect patient safety as more biosimilar medications come to market.
[READ: Ensure Patient Safety When Naming Biological Medications]
FDA’s Record on Biosimilar Naming
The FDA’s final stance boils down to two choices:
- Use a randomly generated suffix to distinguish biosimilars from their biological innovator product and each other, OR
- Use meaningful suffixes that health care providers and patients are more likely to remember.
These four-letter suffixes, also known as biological qualifiers, differentiate medications’ nonproprietary names. The FDA has at different points in time endorsed both random and memorable suffix systems.
The FDA first 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. Though roundly criticized for its tentative approach, the FDA’s choice did suggest that a meaningful suffix would enhance the name’s memorability.
Nearly six months later, however, the agency released draft guidance indicating that it might deviate from its earlier approach. The FDA proposed using randomly generated suffixes while also agreeing to consider a format similar to its initial approach – using the suffixes to reference medications’ manufacturers.
The FDA accepted comments on its draft through October 27, 2015.
Naming and Patient Safety
In a letter to the FDA, the Alliance for Patient Access noted that, “FDA’s proposed naming rule would be more useful to prescribers if the qualifier incorporated meaningful letters and/or numbers that identity each product with its manufacturer,” explaining that “physicians, pharmacists, and patients would more easily memorize and recognize these codes and the medications they identify.”
Memorable names could allow doctors to more quickly, accurately determine which biological medication a patient takes and to address problems. This would allow physicians to keep patients safe and to determine more easily which medication works best for each patient.Tags: Biologics, Regulatory Issues
Categorized in: Blog