The AMA's House of Delegates will meet June 7-11 in Chicago, and they'll be voting on a call for nondifferential naming. In other words, asking that biologics and their biosimilar cousins should be referred to by identical names. That's both bad science and dangerous public policy. After all, according to the FDA, there will be four distinct categories of biosimilars (i.e., not similar, similar, highly similar, and fingerprint similar). The AMA proposal doesn't even distinguish between these categories. What it would do is purposely blur important healthcare issues for physicians and patients, taking away doctors' ability to prescribe precisely what they want, and hiding from patients exactly what they're getting. The dangerous misdiagnosis is that, by calling dissimilar things by the same name, more biosimilars will be prescribed, thus decreasing costs. It's a false promise with dangerous consequences. Fortunately, the forthcoming debate and vote affords the country's leading medical group the perfect opportunity to take a firm and forceful stand against this mistaken proposition.
Let's employ some common sense here. Suppose a couple were to give birth to a set of fraternal twins: would it make sense to name them both “Tim,” on the grounds that it would “level the competitive playing field” as they grew and mastered their fate? Or do the boys have the right—and the rest of world an interest—in being able to tell them apart? And while we're on the subject of names, let's remember that the name “biosimilar” was coined for a reason—the products are not identical, as with fraternal twins, who are not identical. (Even if they were—and you wanted to marry one of them—you'd probably want your “choice” to be “informed” by their having distinguishable names.)
Biosimilars are already available in other parts of the world. This gives us a unique opportunity to learn from the experiences of those markets. In Europe, where biosimilars share the same names as their originator product, there have been an increased number of adverse events, and it can take months for manufacturers to determine if their product caused a problem. Days can mean lives. Months are not acceptable.
Thailand also uses nondistinguishable drug names, and that has led to a dramatic increase in life-threatening adverse events and near futility in efforts to track back to which products are causing specific problems. Australia opted for distinguishable codes for all biologics, and they appear to be experiencing successful rollout and uptake of biosimilars.
It's a universal reality: Labeling something with a distinct name is fundamental to telling it apart from something else. Nothing more informs American competitiveness and informed consumer choice. No entity more than the AMA should recognize that fact-— and be its champion.
Dr. Bert Petersen is director of the Breast Surgery Clinic of St. Barnabas Hospital in the Bronx, New York and adjunct associate professor of surgery at the New York University School of Medicine. Peter J. Pitts, a former FDA associate commissioner, is president and co-founder of the Center for Medicine in the Public Interest.
