In an Attempt at Clarity, FDA Makes the Biosimilar Naming Convention Even More Confusing
The U.S. Food and Drug Administration (FDA) and some biosimilar and generic drug advocates were concerned that the naming for biosimilars—the branded drug’s name and a unique, four-letter suffix—made the drugs sound inferior to consumers than their branded counterparts. So in January 2017, the agency decided to retroactively add a suffix to all previously approved biologic drugs. Now they’ve changed their mind.
And it seems likely consumers won’t notice one way or the other.
A biologic drug, or biologics, is produced from living organisms. Most of the current top-selling drugs in the world, like AbbVie’s Humira, are biologics. But some classic older drugs, like insulin, are also biologics.
A biosimilar is, essentially, a generic version of a biologic. However, unlike a generic of a small-molecule drug, which is an exact copycat, biosimilars are—as the word implies—similar to the brand drug, but not an exact copycat. As such, they are required to go through an approval process similar to that of the original branded medicines. Their clinical activity is identical or extremely close, but there is concerns that the labeling implies the biosimilars aren’t as effective or as safe as the originator drugs.
Given that most of the new biologics are extremely expensive, the federal government has targeted biosimilars, which are slightly less expensive than their branded brethren, as a potential solution to the problem of high drug prices. The biosimilar market in the U.S. has been slow to catch on, especially compared to Europe.
In mid-2018, the FDA launched its Biosimilars Action Plan which, according to Commissioner Scott Gottlieb, was designed to help “make the process for developing biosimilars more efficient.” At that time, there were only three biosimilars on the market in the U.S., although 11 had been approved. Many companies slowed market penetration via lawsuits and pay-to-delay schemes, which the FDA is also targeting.
In a statement yesterday, Gottlieb noted, “By applying this policy to originator and biosimilar products alike, the FDA sought to advance the goal of patient safety—which the suffixes promote—without creating a misimpression that products with such suffixes are somehow inferior to those without. In addition, the FDA announced in that guidance that the agency was considering the process to retrospectively change the names of biological products already on the market, to begin adding distinguishable suffixes.”
Although the change is likely to appease some in the industry, it seems unlikely that the average consumer will note the difference or even be familiar with the terms “biologics” or “biosimilars.” They are much more likely to be told by their pharmacist or physician that they are receiving a generic version of whatever drug they are expecting.
Biosimilars Review & Report, clearly not a typical consumer, notes, “The continuing use of the 4-letter suffix is controversial not only because of the reasons stated by Dr. Gottlieb, but also because these designations have not been used to any significant extent in safety reporting. As stated here and in Biosimilar Development, these suffixes have been reported in fewer than 5 percent of all drug safety reports filed with the FDA to date (but without causing issues as to which biosimilar was associated with an individual report). The updated guidance reaffirms the FDA’s commitment to the use of these suffixes.”
The Biosimilars R&R article points out that the FDA policy isn’t likely to make a difference in terms of pharmacovigilance security, partly because, even for people in the field, the suffixes are difficult to remember, which is “precisely why they will not generally be used in drug adverse event reporting.”
So far, 17 biosimilars approved by the FDA have been approved with a suffix, and the 27 originator biologics have hit the market with the four-letter additions.
Gottlieb stated, “We expect that as time goes on, and more biological products are introduced to the market with distinguishable suffixes, patients and providers increasingly will understand that the suffixes reflect a consistent naming convention and are not an indicator of product quality.”
Will this solve what the FDA views as a problem? Well, the naming convention was confusing before and this doesn’t seem to do anything more than confuse it more. Part of the problem is simply that drugs can have too many names, regardless of whether they are small-molecule drugs or biologics. The FDA document on the changes has a glossary that defines “core name,” “nonproprietary name,” “proper name,” “proprietary name” and several other terms such as “biosimilar product,” “interchangeable product,” and “originator biological product.”
One example is Amgen’s Neupogen (the proprietary name or brand name), which has a core name of “filgrastim” and “epoetin alfa.” Pfizer’s biosimilar of Neupogen has a brand name of Nivestym, whose core name is filgrastim-aafi. Novartis’s Sandoz biosimilar for Neupogen has a proprietary/brand name of Zarxio, with the core name filgrastim-sndz.
For all that, while the FDA believes this will provide clarity and help biosimilars enter the market, many in the industry believe the opposite. Christine Simmon, executive director of the Biosimilars Council, a division of the Association for Accessible Medicines (AAM), stated, “FDA’s current requirement of suffixes presents a significant, artificial barrier to biosimilars that is misaligned with the agency’s own Biosimilars Action Plan and the Trump administration’s commitment to lowering drug prices for America’s patients.”