The Food and Drug Administration’s final guidance on its naming policy for biosimilars has caused some stirring. Although it could never please everyone, the decision to require four-letter suffixes on biosimilars as well as existing biologic products does move the discussion forward.
Naming or renaming new and existing biosimilars is one thing. Renaming existing biologics is quite another. Those familiar with how pharmaceuticals are ordered, inventoried, and dispensed understand the scale of the information technology (IT) effort needed in terms of people and time. Don’t get me wrong, it can be done, but at a significant cost.
The first quantification of exactly what would be entailed in assigning suffixes to approved biologics was laid out by the American Society of Health-System Pharmacists (ASHP). In a February 13 letter to the Office of Management and Budget, ASHP stated the responsibility for updating IT systems would fall on public and private health plans and insurers. However, hospitals will also have quite a burden, including updating medication lists on their electronic medical records, scanning and labeling software, and revising pharmacy automation software and databases. In addition, the estimate points out the problem of having to discard medications that do not utilize the 4-letter suffix, assuming that the updated IT systems cannot identify both conventionally and newly labeled biologics.
The Society cited an estimate from the University of Utah Health Care’s Drug Information Service of approximately 40 hours per product. And this figure does not consider possible changes to pharmaceutical contract language. “All of this work would need to be accomplished using existing resources, thereby diverting human and financial capital that could otherwise be applied to clinical priorities. Conservatively, the dollar value of this work is thousands of dollars per each product,” according to ASHP. “With thousands of biologics currently on the market, extrapolating these costs across our healthcare system produces implementation cost estimates of, at minimum, tens of millions of dollars.“
Although FDA’s naming guidance for biosimilars has a basis in logic—to assist in identifying these biosimilars from each other and from the originator products, it is not at all clear that extending the use of meaningless four-letter suffixes to the originator agents is worth the effort. If infliximab is mentioned without a suffix, whereas its biosimilars are, does that not differentiate this agent? The assignment of a suffix to biosimilars only could save a significant amount of administrative resources, without loss of surveillance or tracking ability.