Lee Schwartzberg, MD, FACP: Biosimilars are still fairly new in the marketplace. And what I have found personally is that there are still misconceptions among physicians, the medical oncologists, and advanced practice providers about what a biosimilar is.
The first thing is that it’s not a generic. It’s not a small molecule that can be manufactured simply and repetitively like Xeroxing something; I’m being a little hyperbolic, but it’s simpler than making a biologic in a living organism. So they have to understand that there are going to be differences, and they also have to understand the very different regulatory process, how the drug gets from being made to being approved. And they have to get comfortable with that.
It does require an educational activity, and multiple educational activities I think it’s fair to say. We started a few years ago with the supportive care drugs, so people had at least a passing familiarity with biosimilars when it came to the therapeutic biosimilars, particularly biosimilar trastuzumab and biosimilar bevacizumab, which both came on the market around the same time in the last year. We did a more intensive educational effort to reinforce the high similarity, that there’s at least 1 large-scale clinical trial that shows within a narrow range that the efficacy and safety are the same of these drugs. And an educational effort around the extrapolation as per the label of the biosimilars, which say you can use it in other indications for which the originator has been approved.
So with those provisos, we have as we normally do, have to reinforce this, for people to get comfortable in using these drugs. Once they understand the principles, which again, are a little different than what we were brought up with, I think they get very comfortable with it. The safety and efficacy really are part of the fact that if they’re similar drugs, they’re going to have the same efficacy and safety. It’s really buying into the concept of biosimilars rather than looking at the specific efficacy and safety because that’s been proven in 1 setting and extrapolated for others.
Once the educational effort is successful and people start to get comfortable with biosimilars and understand the value of a less expensive drug that works the same way, then they can be incorporated into practice guidelines. Virtually all practices today have guidelines, and many of them go from the NCCN [National Comprehensive Cancer Network] guidelines, which also recommend the use of biosimilars in this setting, and particularly trastuzumab for HER2 [human epidermal growth factor receptor 2]-positive disease, as one example. And so that gets incorporated.
In our own practice we’ve had to write regimens or guidelines for the drug usage to include the new biosimilars. Since some patients are still on the originator product it’s been a little more complex because we’ve had to have both simultaneously. And the other complexity that I didn’t mention before is that different insurers may mandate the use of a different drug. This has added a tremendous amount of complexity in community oncology and cost to the system, which one could argue is not value-based in the general term because I have to maintain stocks of various drugs based on the insurer that the patient has. You have to be very careful to use the right drug to get reimbursed, even though we’re very confident that any of them would work and that we would like the ability to pick which drug we would like to use, but that’s not the system we live in today.
That said, we do have preferred regimens, and we would make biosimilar trastuzumab our preferred regimen and for all new starts. Unless insurance dictates that we have to use a different brand or even the originator in some cases, then we will use a biosimilar.
It will be important in the future to monitor the outcome of using biosimilars because the evidence base is admittedly small. This has been done in Europe for the years that they’ve been available, and they will also be done in the United States. There will be a methodology for long-term follow-up through registry and other reporting mechanisms, and increasingly the use of what we call today real-world evidence, which will be aggregation of large data sets to see how patients do with these drugs. Which of course, we’ve always had that issue.
A clinical trial population is very different than the real-world patients who get a drug. So monitoring these patients, and now that we have an electronic health record system that we can aggregate data and have good outcome information on, we’ll be able to follow biosimilars. And it will be particularly important for that group because the evidence base was less.
Transcript Edited for Clarity