Gillian Woollett, MA, DPhil: So, one would be most polite in using the term “misinformation.” What are we actually saying? We’re saying that some companies are promoting a concept that is overtly misleading, that biosimilars are somehow—let’s say, less effective—in nature of their development, which means they’re less reliable than the reference product, is that right?
Juliana Reed: So…those misleading pieces of information are outlined in [Pfizer’s] citizen’s petition. But I want to go back to what Carlos said—and we saw this when we launched the first biosimilars in Europe 10 years ago, and the same misinformation was introduced in Europe, and we’re seeing that again today in the US, and it’s to lower the confidence and the prescribers and the patients in using biosimilars.
Ten years ago, we asked the [EMA, European Medicines Agency] to help us with that, and the same programs and actions…that Carlos outlined were taken by the EMA 10 years ago, where they were the source. And this is key. The FDA, like the EMA, needs to be a primary source of education on biosimilars regarding their safety and efficacy, and we need to help distribute and disseminate that information.
The FDA, like the EMA, needs to combat the misinformation that’s out there about biosimilars and send letters to these companies, the reference product companies that are doing this, or other organizations. It’s time. We need that here in the US.
Gillian Woollett, MA, DPhil: So, Kashyap, as a physician, as a provider, what have you seen from the clinical side, working with patients about this sort of misinformation that’s out there? Are you seeing it in day-to-day practice? Do you understand what’s being alluded to here by the sponsors?
Kashyap Patel, MD: Thanks, Gillian. I think I have a little different perspective on this. I was not so much aware of this misinformation campaign, for the lack of better words. I wouldn’t use that, but I’ve done some intensive physician education at 5 national meetings in the last 2 months, and I was very unpleasantly surprised to find out so many misconceptions among physicians who are the prescribers.
I spoke at 3 large meetings and 1 of the national conferences, and the first question a lot of physicians asked me was “So, what’s the difference between a generic and biosimilar?” And I said, “Oh, where do I start here?” Because there’s a huge difference between a generic drug and a biosimilar. The generic drugs do not have the new trials; they are simply chemical components called [API, active pharmaceutical ingredient]. You buy it in a bulk, like kilograms or a ton, and convert them into the tablets.
But because there was a perception that there’s not a lot of difference between the generic drug and biosimilars, they say, “Well, why are they priced so high?”
And I said, “Listen, these drugs have to undergo multiple steps that establish the totality of evidence compared to the referenced product. It’s not an easy task. It’s not an easy solution, and that’s 1 of the reasons why you don’t see a huge price, or you definitely would see some of incremental decline in the price, but you don’t expect them to behave like generic drugs that happened back in 2004, 2005, 2006, when the paclitaxel went generic, when carboplatin went generic, when cisplatin went generic.”
So there’s a lot of misconception. It may not be intentional that they’re not learned, but we have to do a lot of—at least now—education at the physician level to have them become aware of what biosimilars are as a different class.
And the second observation I made was that patients were not as much reluctant with biosimilars, and then I’ll share, when our discussion points in the direction, that for patients who are least likely to resist adoption of biosimilars, I think the providers, the nurses, the mid-levels, and maybe the peers of the team that we need to work with in educating about biosimilars and what the class of drug is.