WASHINGTON – The Alliance for Patient Access (AfPA) issued the following statement today on the FDA’s final guidance on the nonproprietary naming of biological products.
STATEMENT FROM BRIAN KENNEDY, EXECUTIVE DIRECTOR, ALLIANCE FOR PATIENT ACCESS:
“The Alliance for Patient Access is pleased that FDA has determined that distinguishable names are vital for the expanding biosimilars marketplace. Biological medications’ four-letter suffixes will differentiate their nonproprietary names, allowing physicians to accurately determine which medication a patient takes and to address any problems that might impact patient safety.
“According to this guidance, however, the four-letter suffix will be randomly generated and devoid of any meaning. 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.
“We appreciate FDA’s efforts to engage all stakeholders and integrate their input into the final guidance, and we applaud the agency for reiterating the primary focus on pharmacovigilance and patient safety in the use of biological medications.”
The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.