In the Name of Patient Safety: Why Biosimilars Need Distinct Identifiers
July 25, 2014
By David Charles, M.D. and Amanda Conschafter, Blog Editor
An opponent to distinct names for biosimilar medications has petitioned the Food and Drug Administration with a new argument: Same old, same old works just fine. The National Council for Prescription Drug Programs (NCPDP) recently told the FDA that assigning distinct names to biosimilars will require adjusting the code in some pharmaceutical and drug compendia databases. The process would be burdensome, the organization claims, so it’s better to maintain the status quo.
What they fail to recognize is that biologics aren’t like typical pharmaceuticals. In fact, the technology behind biologics is so revolutionary that Congress and the Food and Drug Administration created an entirely new regulatory pathway to accommodate the complexity of these innovative therapies. It only makes sense that we therefore reconsider our approach to naming as well.
The naming debate centers specifically on whether or not biosimilars will carry distinct international nonproprietary names (INNs). Medications have other identifiers, such as brand names, national drug codes, and batch and lot numbers, but physicians, patients and pharmacists most often use the name when referring to medications. Thus, distinct names are essential to prevent confusion as to which therapy a physician prescribes and which the pharmacist dispenses.
NCPDP, however, perverts the cause of clarity by arguing that distinct names for distinct biologic medications will confuse physicians. A little physicians’ common sense can put their minds at ease. I am a physician, and we deal with hundreds, even thousands of medications and medical terms on a regular basis. Giving biosimilars different names than their biologic reference products would hardly upset the proverbial apple cart.
What would confuse patients and doctors? Giving the exact same name to two different medications – no matter how similar they might be.
Just imagine if the federal government decided to call, for example, the Honda Accord and the Toyota Camry by exactly the same name. Suppose then that a serious manufacturing defect became apparent, requiring an urgent recall. Until exhaustive lists of unique vehicle identification numbers could be scoured to determine which cars must be returned, drivers of these similar sedans would be left to wonder: Is it safe to drive home from work? To pick up my kids from school?
In the same way, if the NCPDP request to give exactly the same name to different biologics were actually implemented, then all patients on a biologic under that name would think that they are all on exactly the same medication when in fact they are not. A serious adverse event cause by one biologic with that name would leave all patients taking a medication with that name in distress – even though the actual medication they are taking is not identical to the one named in the recall… because, as the FDA has concluded, there are no generics when it comes to biologics.
Tracking and reporting such adverse responses to medications, a process known as pharmacovigilance, is particularly crucial with biosimilars and biologics. These medications are non-identical, because biologics’ cell-based nature precludes exact duplication. Biosimilars can be highly similar and may well provide comparable results for the patients who take them. But patients do need to know which medication they’re taking, as do their physicians. Transparency allows physicians to monitor individual patients’ response to biologics and biosimilars. And, as more biosimilars become available, accurate data will allow physicians to detect trends, such as which patient subpopulations respond better to specific biologics or biosimilars.
The World Health Organization, acknowledging these important differences, is also weighing the possibility of distinct names. WHO created the INN system in 1950, long before medications with biologics’ level of molecular complexity and uniqueness existed. Because biologic medications introduce a new paradigm altogether, WHO is considering, among other options, assigning biosimilars with distinct names that consists of the original biologic name plus a biosimilar-specific suffix. WHO acknowledges the need for biosimilar naming “to be addressed globally and soon.”
Achieving that global solution will require cooperation throughout the health care sector and related communities. Keep in mind, biologics are breakthrough drugs. These modern-day medications give many patients a viable, valuable chance at remission, recovery and symptom relief. They may require us to reconsider a half-century old approach to naming medications. They may require reconfiguring the code that supports the insurance and pharmaceutical communities. So let’s work together to make these adjustments.
Resistance to change is no excuse when patient safety hangs in the balance.Tags: Biologics
Categorized in: Blog