Naming

BPC applauds FDA for recognizing in its final guidance that each biological product needs a distinguishable non-proprietary name, including previously approved originator drugs. Distinguishable names for biological products foster pharmacovigilance through a detailed ability to track adverse events, a necessary step to preserve patient safety. FDA’s final guidance states that all biological products will bear a nonproprietary name that is a combination of a core name and a four-letter suffix, devoid of meaning. However, as BPC has voiced previously, biologics prescribers tell us that the suffix should be memorable, which cannot be easily accomplished when it is meaningless. We remain concerned that randomized four-letter codes may complicate the achievement of FDA’s goal to facilitate pharmacovigilance and prevent inadvertent substitution. In addition, interchangeable biosimilars should be assigned distinguishable names. Additional perspective on this issue provided in our related material.