Switching Treatment From Biologics to Biosimilars
The panel explores the appropriateness of switching from a biologic to a biosimilar through consideration of factors such as the curative vs noncurative setting, the EMR system, and patient education.
Bhavesh Shah, RPh, BCOP: Regarding the whole skinny label, Marc had actually mentioned how some manufacturers come out with maybe 1 or 2 indications for the drug. Does it mean that that drug doesn’t work for the other indication? A lot of providers may not know that a lot of times manufacturers are pursuing those 2 indications because it’s going to take them much longer to actually get approved for the indications. It may be that the drug has an orphan indication, so they can’t actually get that until that orphan indication timeline has expired. Or it may be that there is a patent on that specific indication, and for them to overturn that, it would require significantly more time, which means that there’s a lot of revenue that they’re losing.
They’re basically going after the indications that they can facilitate faster adoption or approval into the system. That’s the whole skinny label, and it has nothing to do with whether the drug doesn’t work in those indications.
Anthony Mato, MD, MSCE: Do either of you have differing opinions about some of those areas in terms of patients’ specifics and choice?
Tim Peterson, PharmD, BCOP: One interesting thing when you’re looking at which patients are appropriate to use a biosimilar in the newly diagnosed or relapsed setting is that when we look at the European experience, they got a head start. When they initially published some of their 10-year experience, some of the surveys were published about physician preference for biosimilars showed that there was a lot more utilization in the context of noncurative and heavily relapsed states.
Initially, oncologists were still favoring the biologic reference product for patients who had a curative intent. I think that was early adoption, and I believe Bhavesh referred a little to how the adoption of these biosimilars in Europe have exceedingly increased. But I think that in the United States, right now we’re in that infancy stage with biosimilars, where we’re having this exponential increase in their numbers. But it’s going to be interesting to see how many oncologists are feeling comfortable to use in a curative state versus the noncurative state.
Anthony Mato, MD, MSCE: That’s the debate I’ve heard the most.
Tim Peterson, PharmD, BCOP: I know we mentioned earlier some of guidelines that are coming out. I believe in 2019 we started to see the biosimilars starting to make their way into the NCCN [National Comprehensive Cancer Network] Guidelines and into ASCO [American Society of Clinical Oncology] guidelines. That’s going to be 1 of the biggest drivers for oncologists, maybe using it in multiple contexts. But we’re in that stage now where we’re going to find out what providers feel comfortable with.
Marc Earl, PharmD, BCOP: The other perspective is not just a clinical aspect of a new patient versus an old patient, but we have to go into the EMR [electronic medical record] and switch orders out for a large number of active patients to switch them over. We did this with the Remicade [infliximab] space.
Anthony Mato, MD, MSCE: Do the pharmacists do that? Do the practitioners do that? Who’s doing it?
Marc Earl, PharmD, BCOP: For Remicade, we did switch to a biosimilar, and we had pharmacists, with physician approval, go in and modify order to the correct biosimilar we wanted to use. We had to pay overtime hours for a large number of pharmacists to go into the EMR and utilize this. You have to take that into account when you’re thinking about new versus active patients.
The other perspective would be the patient information and education that they receive. Does your institution feel that they should be re-consented for therapy? Should they be told and acknowledged that they are switching to a different drug? Or is it just a different type of trastuzumab that they’re going to get, and we continue on with treatment? Those are the decisions the hospital has to make and that can affect the logistics around patient factors as well.