The Alliance for Safe Biologic Medicines commends the FDA for its leadership on biosimilars by releasing guidance that recognizes the need for all biologic medicines, including biosimilars, to be clearly distinguishable from one another. This clarity will aid in accurate product identification during prescribing, dispensing, and pharmacovigilance. Distinguishable naming is particularly important with the arrival of biosimilars, so that any unexpected effects or adverse events can be attributed to the correct product and that non-interchangeable biosimilars are not inadvertently and/or inappropriately substituted.
It has long been ASBM’s view that distinguishable naming will allow physicians to maintain an accurate patient record, help pharmacists promote patient safety, improve adverse event reporting, and promote manufacturer accountability. Further, the four-letter differentiating suffix proposed by the FDA is potentially compatible with the four-letter Biological Qualifier (BQ) suffix proposed by the World Health Organization (WHO), which if adopted would extend the protections of distinguishable naming to patients throughout the world, regardless of in which country they receive treatment.
While the FDA’s proposed four-letter suffix will prevent unnecessary and potentially harmful ambiguities, there still remains room for improvement. In particular, the differentiating suffix deliberately designed to be “devoid of meaning” creates an unnecessary barrier to the use of distinguishable suffixes. It is ASBM’s position that a uniform and meaningful, intuitive suffix applied consistently to all products by a single manufacturer would be more memorable and thus easier for healthcare providers to use, limit proliferation of suffixes, and reduce the likelihood of juxtaposition or confusion. The four-digit code used in FDA’s approval of the first biosimilar, Zarxio (filgrastim-sndz), for example, is clearly based on the name of the biosimilar’s sponsor, Sandoz. Unlike the proposed random and meaningless suffix, “-sndz” is not only memorable and logical, but it promotes manufacturer accountability.
ASBM welcomes the chance to submit further comments on the draft guidance and once again thanks the FDA for their leadership in releasing biosimilar guidance that reflects its longstanding commitment to patient safety and transparency.