When it comes to developing nonproprietary names for pharmaceuticals and biologics, the goal remains consistent: to obtain an appropriate name from the regulatory agency where nonproprietary name candidates are submitted and approved. “Appropriate” is a broad term, but from a regulatory perspective, an appropriate name means that the compound fits within the taxonomy of nomenclature set forth by the INN (International Nonproprietary Name) Expert Committee and/or the USAN (United States Adopted Names) Council. A nonproprietary name shows credulity in the future of the compound and can be an effective way to attract investors. Today, to the company submitting name candidates to INN or USAN, a nonproprietary name often represents more than adding a prefix to an appropriate suffix. Drug developers would like the nonproprietary name of their product to express as much meaning as possible. Several questions are ticked off a wish list, based on circumstances such as, “Can we get a strong, warrior-type name because we are fighting a deadly virus, or a soothing, soft name because we intend to ease the pain of migraine headaches?”, or “Our mechanism is novel but may be viewed in a broader sense by INN or USAN. Can we provide substantial scientific differentiation to warrant a new stem according to the regulatory decision makers and therefore be considered a first-in-class compound?”, or “How far is too far when trying to embed messaging in the prefix of our nonproprietary name?”
Once the scientific direction has been identified, name creation begins. Everybody enjoys creating names, especially those with messages that speak to the concept of the compound – innovative, safe, effective, and novel. On that note, what are the odds of getting inovelimab approved? Zero. First, the name embeds novel in its entirety, making it overtly promotional, and promotional messaging should be avoided according to the General Principles for guidance in devising International Nonproprietary Names for pharmaceutical substances. That was the easy part. Second and more challenging, comes the test of creating a nonproprietary name that is distinct, or distinct enough, from existing nonproprietary names. How is that lofty goal achieved, especially since nonproprietary names are created within stem classifications and therefore inherently similar? While creating around the concept of novel, the name inovelimab is created but conflict checking shows us that it is similar to the already approved names, inotuzumab and inolimomab. Depending on the suffix, nonproprietary names run the risk of similarity within their stem family, and surprisingly, outside of their stem family. As you can see, many names are created and discarded before arriving at a viable name candidate for submission to INN or USAN. We are tasked with one goal in mind: a distinct name that is not considered to be in conflict with another name by the approving regulatory agency. This ensures overall patient safety by limiting the potential for medication errors via prescription misinterpretation and avoiding confusion in a medical setting.
While creating names one must take into consideration the multiple languages in which word parts may mean something negative or promotional and therefore objectionable which is also part of the General Principles that govern what is found acceptable for dispensing purposes worldwide. For example, nelza means “not allowed” in Russian which could have a negative impact on the drug should it be marketed there. On the flip side, it is no surprise that of the thousands of approved nonproprietary names, not one name begins with the prefix bon, meaning “good” in French.
Distinctive, unique names that also clearly identify the medication’s purpose, by way of scientific classification, prove to be an essential component in the communication amongst our health care professionals and patients in the prevention of medication errors.
By: Sandra Van Laan