I belong to a local business group where I live in the Philadelphia metropolitan region, and I had the pleasure of speaking to them about my profession. A member of the group asked what topic I most enjoyed covering in the last few years.
I drew a breath, and reluctantly answered, “I really enjoy working in the biosimilar area.” Blank stares. Very much expected. The members of this group included lawyers, service professionals, a chiropractor, and representatives of the trades. Likely, one or two had received a biologic at some point or who had a spouse who had.
Recognizing the dilemma at hand, I offered a grain of context. I asked, “How many of you have seen Humira® or Enbrel® commercials on TV?” All raised their hand. “Those medications, injected through a syringe or given through an IV, are called biologics. These are very expensive medications. A biosimilar is basically a generic version of the biologic drug.” Blank stares dissolved into acknowledgement.
We tend to forget that education about biosimilars produced by pharma companies, the FDA, and news media rarely reach the lay public. Patient advocacy groups have a stake in biosimilar education, but they only reach patients and their families affected by a particular disorder. Biosimilars is not a topic that lights up social media.
For the vast general population, the term biosimilars doesn’t register. To them, a biosimilar drug is another brand, because that is how they will refer to the drug—not as filgrastim-sndz. On the other hand, generics are not branded. The one specific differentiating fact is that a biosimilar is a nuance of regulatory policy. Try explaining that to the person on the street, and he or she will run the other way. Without the ability to talk about regulatory differences, the public will rely on their existing knowledge for an understanding of biosimilars.
For example, the only differences between tbo-filgrastim and the originator product Neupogen® are the brand names and the minor differences in physiochemical structure that do not materially affect clinical outcomes. However, Granix® is not considered a biosimilar, because it was not approved via the 351(k) biosimilar pathway (which did not exist at the time of approval). Therefore, the public considers Granix as just another brand of filgrastim. From their point of view, what is the difference between Granix and other filgrastim products officially approved as biosimilars? The brand names.
The FDA’s most recent biosimilar decision would require even a more complicated explanation to a layperson. Semglee® (insulin glargine) was first approved under a 505(b)2 new drug application. Subsequently, the drug’s manufacturer (Mylan) decided to seek biosimilar status and more importantly interchangeable status, which was granted in late July. This is the first time a drug approved under the conventional FD&C Act was now approved under the regulatory framework of the Public Health Services Act. Try explaining that to someone outside the industry!
This does complicate the way in which we educate the general public about the availability of biosimilars. In reality, all laypeople will eventually become patients. If people ask for lower-cost options for their biologic medications, the path of least resistance is simply to inform them that other brands are available. It may well be that those brands are on a lower cost- sharing tier, or that this discussion never takes place: the biosimilars are preferred by the patients’ health plan in the first place.
Was my characterization of biosimilars as “generics for injectable pharmaceuticals” sufficient to the task? Does it provide the biosimilar education that is most helpful for the lay population? Unless the public starts asking the difficult and specific questions, as in “is this product a biosimilar?” it may have to suffice. Otherwise, I may find myself in regulatory explanations around the obscure differences between simple brands, biosimilars, interchangeable biosimilars, and their reference products.