Gillian Woollett, MA, DPhil: Well, then certainly I think what we’ve seen is that half of the problem is not exclusively wrong in the statements, but they’re ill impressions, and it starts with the name. For basically 15 years, we’ve seen that “biosimilar” means similar and not the same. But that forgets about no meaningful clinical differences having been determined by FDA. Now, obviously at this point in the debate, we’re not going to rename biosimilars as anything else. So what do we now do about it, given that complete information is a challenge? People use shorthand. Does this mean that we have to target specific populations in those settings where this misleading information is already out there? Is it certain stakeholders? For instance, you’ve alluded to the patients perhaps being less concerned if their healthcare providers have confidence.
So, is it physicians, patients, nurses, payers? For any of the panel, are there particular people who’ve got to have this full understanding, using FDA with primary sources? FDA does have on their website already that every biosimilar approved by them is as safe and effective as any other biologic. What is the form of the information that we need? What do these stakeholders need to receive?
Juliana Reed: So, I think the stakeholders need to receive, and this is key in order to combat the misinformation, they need to receive the FDA educational materials. And as either industry or physician groups or patient groups, other stakeholders—insurers and payers—we need to help disseminate that. We need to proactively help the FDA to get that—those materials—down to the physician office level. It’s the source. The FDA needs to be the source of all truths about biosimilars.
Gillian Woollett, MA, DPhil: Just as in Europe we see all that with the [EMA, European Medicines Agency] and with the commission. Carlos, as a physician and as a sponsor, what have you seen similarly? You have launched products, too.
Carlos Sattler, MD: Sure. A couple of thoughts based on the question that you asked: You’re right that because biosimilars are highly similar to the referenced product but not identical by the nature of the fact that they’re biologics. That is a handicap, if you may, although biologics are inherently variable. That’s just the way they are, because unlike a generic that is manufactured through chemical synthesis, biologics need to be produced in living organisms, and that by its nature introduces some variability that occurs from lot to lot, for example.
And I think a lot of the misinformation or misunderstanding comes from that. A generic is identical to the reference product because it’s a small molecule, and, therefore, you expect the same clinical effect. Biologics are so complex, and the biosimilar is not identical to the reference product; maybe you’re going to see some difference in clinical effect. But like you mentioned, even though there is this variability in biologics that makes a biosimilar not be identical to the reference product, it must meet the criteria of no difference in efficacy, safety, and immunogenicity, and I think that’s what’s lost. And I think education—basic education—on what a biologic is would go a long way, obviously adapted to the audience.
But to add to what Juliana said, where should the source of education come from? Certainly the FDA, I completely agree. It’s a trusted source; it’s independent from manufacturers. But I’d like to talk about how EMA went about this, right? EMA started education, but they brought in a series of stakeholders in order to create guidance documents. This included manufacturers; it included professional societies; it included patient and patient advocacy groups; it included payers and others. And so now they created this consensus among all stakeholders that put out educational material, and I think went a long way. I think the FDA should look at that and maybe try to do something that is similar.
In the end, I think it is a responsibility of many stakeholders to educate about biosimilars—not just the FDA—and it could be done through a single multistakeholder setting, but certainly patient advocacy groups, professional societies, manufacturers, and managed care to their membership should also assume that responsibility. I think for biosimilars to succeed…the educational effort has to be multiprong.