FDA Settles on Random Suffix Approach for Naming Biologics & Biosimilars
January 16, 2017
The names of biologic and biosimilar medicines will include randomly generated four-letter suffixes, the Food and Drug Administration announced Thursday.
The agency’s final guidance followed years of debate over whether – and how – to differentiate the nonproprietary names of these similar but non-identical medicines. Following Thursday’s release, patient advocates generally applauded the FDA for recognizing the need for distinguishable names. Several groups also acknowledged that memorable suffixes would have been preferable.
- The American College of Rheumatology announced that its group ”has long advocated for explicit guidance about distinct names and suffixes for biosimilars in order to prevent inadvertent or inappropriate substitution, increase prescriber confidence and uptake of biosimilars, and ensure pharmacovigilance.”
- Alliance for Patient Access Executive Director Brian Kennedy explained that, “Biological medications’ four-letter suffixes will…allo[w] physicians to accurately determine which medication a patient takes and to address any problems that might impact patient safety,” though he admitted that, “As patient advocates, we would have preferred a memorable suffix, which is the surest way for patients and providers to know which medication is being taken.”
- Meanwhile, the Biosimilars Forum described being “disappointed in [FDA’s] decision to apply meaningless suffixes in the naming convention for biological drugs,” explaining that “they will likely lessen the ability to carefully track the identity of the biologic drug administered to patients, thereby contrary to the stated purpose of having a suffix to enhance pharmacovigilance.”
Up until the final guidance, regulators, industry and advocates had weighed the possibility of using meaningful suffixes that represent the drug manufacturer’s name. The names of biosimilars approved thus far reflect the FDA’s evolving ideas on the topic. FDA explained Thursday that it ultimately opted against memorable suffixes to avoid potentially confusing name changes when drug licenses are sold from one manufacturer to another.
Under the new guidance, both existing and forthcoming biologics and biosimilars will carry four-letter suffixes. Distinguishable names will smooth the process, including “ordering, prescribing, dispensing, record keeping and pharmacovigilance,” an FDA spokespeople explained in a call on Thursday.
The FDA has not yet determined the suffix format for interchangeable biosimilars nor offered a timeline for its decision.Tags: Biologics, Pharmacovigilance, Regulatory Issues
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