After 40 years as a pharmacist, the last 20 intimately involved in product identification in my role with FDB (First Databank, Inc.) and my association with the National Council for Prescription Drug Program (NCPDP), I cannot understand why the FDA believes that biologics need unique non-proprietary names.
The FDA has issued final guidance that requires all biologics, not just biosimilars but all biologics, to have unique non-proprietary names. The biologics would be required to add a four-character hyphenated suffix to the nonproprietary name. Their rationale is that without this suffix, we would not be able to identify products from different manufacturers when reporting adverse events.
I have seen no evidence that this assumption is accurate. It has not been tested in any way, and the negative effects of this change in naming convention across the industry have not been considered.
The European Union (EU), which has much more experience with biosimilars, has seen no negative effects of these products sharing a common nonproprietary name. Biosimilars have been available in the EU for more than 10 years. These biosimilars have brand names, as they do in the United States, and that is how they are most commonly referenced.
The same specificity found by appending a hyphenated four-character suffix to the nonproprietary name can be found by adding the manufacturer. Let me ask you to consider a hypothetical scenario: Is it easier for you to remember a drug called biosimilar-rvkz or biosimilar Sandoz?
The FDA’s rationale is that having the specificity by using the four-character suffix is an important patient safety need. How can any reasonable person possibly make that argument when people must remember a name with confusing hyphenated suffixes instead of the established methods of product identification?
I believe the same specificity can be realised by using the brand (proprietary) name or nonproprietary name and manufacturer. More specificity can be found by using the national drug code, which is commonly used within electronic pharmacy management systems and electronic medical records for drug identification. We live in a digital world where codes provide access to more information than names.
The introduction of biosimilars have the enormous potential of saving consumers and payers billions of dollars. Biosimilars will not only lower cost, but increase access. In 2017 IQVIA, formerly QuintilesIMS, estimated that access to two biosimilars in the EU, Epoetin and Filgrastim, increased by 66 percent and 122 percent respectively in 2016 vs. the year before the biosimilars were available.
The disruption caused by this naming convention for adjudication systems, electronic health records (EHRs) and pharmacy management systems will be extensive. These systems, developed using the common nonproprietary name and codes related to it for grouping similar products, will need to be reprogrammed to comply with the new naming convention. The cost for these changes are estimated to be hundreds of millions of dollars.
The FDA is creating a solution to a problem that does not exist. We need only look at the EU for confirmation that the use of a single nonproprietary name for biologics and biosimilars works. So now I have another question: Why is the FDA insisting on requiring this change in naming for biologics?
Tom Bizzaro is vice president, health policy and industry relations for FDB, and regularly blogs about the pharma industry