FDA to Tweak Naming System for Biological Medicines
May 9, 2019
One key to tracing how innovative biological medicines impact patients hinges on a deceptively simple issue: how the drugs are named. New draft guidance from the Food and Drug Administration has reignited the conversation on naming, eliciting feedback from a range of stakeholders.
As a newly released “Fast Facts” from the Institute for Patient Access explains, in 2017 the FDA opted to give biological medicines – both innovator biologics and follow-on biosimilars – distinguishable nonproprietary names. Nonproprietary names are separate from the brand names chosen by a drug’s manufacturer and generally reflect the class of drugs to which a particular medicine belongs.
The FDA’s naming system combines core drug names with four-letter suffixes that are random and distinguishable. For example, variations of the drug infliximab are infliximab-dyyb, infliximab-abda and infliximab-qbtx.
The naming convention supports pharmacovigilance, the ability to track and trace adverse drug events to their source. The issue is an important one for biological medicines, which can affect patients’ immune systems.
As of March 2019, however, new draft guidance from the FDA tweaks the approach to naming. The FDA plans to continue using distinct, four-letter suffixes for all newly approved biologic medicines and biosimilar medicines, including interchangeable biosimilars. But the FDA will not retroactively add suffixes to pre-existing biological medicines that were released without a suffix.
In a letter to the FDA, the Alliance for Patient Access and the Biologics Prescribers Collaborative expressed appreciation for the agency’s attention to appropriate naming. The groups also recognized the FDA’s concern that retroactively adding suffixes could create confusion and generate unnecessary costs for patients, providers and the health care system.
Now that the agency’s public comment period has closed, FDA officials will consider the input received and move toward final guidance.
To learn more about the naming of biological medicines and FDA guidance on the issue, see “Fast Facts: Naming of Biological Medicines.”
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