by Amanda Conschafter, blog editor
How can regulators effectively create distinguishable names for biosimilars? For years, the World Health Organization, U.S. Food and Drug Administration and other drug regulatory authorities have wrestled with this vexing question. Now, a solution may have an unlikely inspiration: the airline industry.
At the WHO’s June Front Page Meeting, stakeholders considered the INN Expert Committee’s proposal to randomly assign a four-consonant qualifier to biosimilars’ names. For example, imagine a hypothetical innovator biologic with the non-proprietary name “amazamab.” A follow-on biosimilar under the proposed system could be named “amazamab-wbtm.” Patient and physician advocates have generally applauded the proposal for encouraging pharmacovigilance. Yet some question whether random consonants would be memorable, helping prescribers and dispensers to distinguish among products.
The FDA took a different approach in naming the first U.S. biosimilar. Filgrastim-SNDZ received a four-consonant qualifier that doubled as an abbreviation for Sandoz, the product’s manufacturer. As with a brand name, a reference to the manufacturer can be more memorable than a randomly generated four-consonant code. However, this approach would fall short if Sandoz manufactured an additional filgrastim biosimilar.
Thus, at the WHO meeting, the Global Alliance for Patient Access suggested a hybrid approach using the familiar example of airline names. The method for identifying airline flights offers an apt analogy for naming biosimilar therapies, explained the Global Alliance for Patient Access’ Brian Kennedy:
Airline flights, like biosimilars, have certain “active ingredients.” In the case of flights, these are the equipment, the fuel and the crew. While no two flights are identical, the active ingredients are similar, and most passengers would be hard pressed to distinguish a Boeing plane from, say, an Airbus one. Yet passengers, travel agents, and airline workers must be able to precisely distinguish among flights, their operators, routes and schedules.
Airlines therefore use a flight identification system that incorporates the operating airline’s abbreviated name followed by a multi-digit qualifier—for instance, DL2035 or UA543. The average traveler is unlikely to memorize flight numbers, but those who work in the travel industry come to know the flight numbers and can readily access flights’ schedules and routes.
The situation with biosimilars isn’t so very different. Patients, physicians, and pharmacists are dealing with similar but different active ingredients. So why not consider a similar approach to naming?
The first two letters of a biological qualifier could represent the drug’s manufacturer. The random consonant code that follows could differentiate the medication from other biologics and biosimilars. The methodology may escape patients, though physicians and pharmacists would quickly learn to recognize these codes and the medications they identify. Further, if a single manufacturer produces additional biosimilars in the same class, this system would permit unique qualifiers for each product—for example, amazamab-SZpx and amazamab-SZnb.
GAfPA’s suggestion received positive feedback at the WHO’s June meeting. And it has maintained the attention of some international stakeholders. In a recent letter to the WHO, the International Federation of Pharmaceutical Manufacturers & Associations acknowledged the idea as one that “would provide a distinguishing element to the [biological qualifier] without undue complexity.”