The Pharmacist Perspective on MS Biosimilars and the Possible Monitoring Needs

WATCH TIME: 10 minutes

The treatment paradigm for multiple sclerosis (MS) has come a long way since the early years of ABCR agents, with a therapeutic arsenal of disease-modifying therapies now numbering in the 20s. Yet, with all of the change that advances in pharmaceutical development have brought, there are still novel approaches being introduced—and perhaps the biggest recent introduction is biosimilars.

With the FDA approval of the first of these new products for MS in the fall of 2023, the era of biosimilar treatments has begun, and in this new era is a new challenge: education and awareness of these options, for both patients and clinicians.

In collaboration with the National MS Society, NeurologyLive^® hosted a Roundtable Discussion focusing on this step forward for MS treatment, the changes that it will bring to care and the healthcare system as a whole, and the resources for the field to stay up to date on their use. Featured in the discussion are Jeffrey Cohen, MD, an MS specialist and director of Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research; Alicyn Magruder, PharmD, BCACP, MSCS, a clinical pharmacist at Mizzou Specialty Pharmacy within the Neurology and Sleep Disorders Clinic; and Sarah Anderson, PharmD, NBC-HWC, a pharmacist and director of Clinical Content and Resources on the Clinical Innovation and Strategy Team at the National Multiple Sclerosis Society.

Resources for Providers and Patients

• Generic and Biosimilar Medications | National MS Society
• Generic and Biosimilar FAQ
• 5 Things to Know About Biosimilars - Momentum Magazine
• Ask an MS Expert: Biosimilars and Generics
• Tyruko News Bulletin
• Patient Assistance Programs
• Guide to Prescription Financial Assistance

Episode 2

Transcript below. Edited for clarity.

Matt Hoffman: From the pharmacist perspective, are those challenges similar? I imagine, particularly with off-label use, insurance coverage can get tricky, and there's obviously again, a lack of data to compare some of these therapies head-to-head. How have we gone about reassuring—because especially now with the natalizumab biosimilar being approved, these conversations are going to start becoming more common with patients—and providing that confidence to patients from the physician and the pharmacy side of things to let them know that the efficacy is comparable, the safety is comparable, there is an FDA is process for reviewing these, and providing that that pharmacokinetic information to the patient?

Alicyn Magruder, PharmD, BCACP, MSCS: I always try to counsel my patients to make sure that they understand that for something to come on to the market, that it did have to go through studies to prove its similar enough to the branded medication. I started out in retail, so not necessarily with MS patients, but anytime a brand name drug goes to generic, it's always a conversation to have with patients—this is a medication that made it to market, but it didn't just make it to market because it says that it's the same, it made it because I had to prove to the FDA that it was similar enough to the branded medication. I make sure patients understand that and I always want to listen to their concerns.

Recently Gilenya (fingolimod), when it went generic, patients had a lot of concerns because they had been on it for 10 plus years. “Who's there going to make me change my medication?” and, “What am I going to do?” I think reassuring them that it's the same, but also be a listening ear for them. It's their body, and they can tell me when something seems off if they start it. There were patients that that I did go ahead and pursue a branded override, and those might be people that had to be on reduced dosing because of lab work, or just because of their anxieties around it.

I think, one, as a clinician, that we have to be very respectful of what our patients know. Educate them the best that we can and make sure that they understand that, really, cost savings to the whole health system is beneficial, but that if they're really experiencing something that seems off, then we are their listening ear to listen to what they're experiencing, so we can know about it.

With the biosimilars, the way they get to the market is a little different than generics, and so making sure patients understand that it's not necessarily a generic—like Dr. Cohen said, it's a more complex molecule, and we have more to do—but we do studies that we submit to the FDA to show that they're similar enough. With natalizumab, we have a study that did basically a trial between the 2 to show that there wasn't any difference in the outcomes that were statistically significant. Making sure patients understand that process has been in place [is important].

Jeff Cohen, MD: I think Alicyn brings up a couple of different key points—the concern that patients and the clinicians that care for them have is that the follow-on product, the generic or biosimilar, is sort of a second-rate copy of medication—it's not going to work as well. I think we can assure them that in the United States, Canada, and Europe, these medications go through very rigorous evaluation and are shown to be comparable to the brand product.

But there are a couple of caveats to that. One is that they're not required to be identical. They're just required to be highly similar without clinically important differences. What that means is that it is possible that an individual person might not do as well on the follow-on product. They may experience adverse effects where they had not previously, but that, in our experience, has been very uncommon. The other sort of subtle caveat is that we hope that there'll be many additional follow-on products after the original one because that increases competition and helps lower costs, but, whereas each of the individual ones are very similar to the original medication, these individual follow-on products may have some variability. That's the other important caveat is that people should not, in general, switch among these follow-on products. And if they do switch, we need some way of keeping track of which ones they're on, so we can monitor which one they did well on and which one they didn't. Those are a couple of the subtleties to this.

Matt Hoffman: And the monitoring part of this, I think, is an interesting conversation. We mentioned earlier that the patients know best what's happening to them—listening to them in that context is super important. So, I'm curious, as more of these products potentially come to market over the next couple years, or at least begin to be explored, the conversations are going to continue—do we envision a need for, or perhaps just even the utility of, a registry for patients that are on these biosimilars? Would that be helpful to understand those batch-to-batch potential differences that that could occur—and again, may be limited—as something to have that could even in the context of a patient conversation, maybe ease some of their fears, that this is not a second-rate product compared to the reference product?

Jeff Cohen, MD: The expected testing that's done before someone starts a biosimilar is the same as one would do for the branded, and the on-treatment monitoring is the same. But you raise a very important point, which is should we also be keeping track of which of the biosimilars someone has been on and what their reaction to that was or has been? In other words, where there should be an additional registry compiling those results? That actually makes sense, but it would be a pretty big undertaking.

On the one hand, the philosophy is that the follow-on product is comparable to the original product, so why should you have to keep track of additional information when you go on that? People in the field have talked about a variety of ways of doing that. The electronic medical record does help in some regard. You can keep track of the specific biosimilar that an individual patient is on, and there are ways of tabulating data within the electronic medical record. But to compile that across institutions would be a big undertaking, and physicians and other clinicians are busy. So exactly how to do that… it's not so clear.

Matt Hoffman: I would wonder, do then perhaps organizations like the National MS Society step in? Is there a role potentially, for that advocacy side to get involved in in maybe gauging even if there is, again, patient interest in that as well? Because, to your point, Dr. Cohen, if it is a massive undertaking, and it would be particularly expensive…if we do understand that these therapies are comparable—not identical, but comparable—if there is not necessarily a need, but there is a patient concern, maybe that's enough to validate that effort. I agree, it's definitely sounds like it would be a challenging undertaking, but potentially something that could be worth the effort.

Jeff Cohen, MD: So there already are some MS patient registries, including some international efforts, we wouldn't have to start from the beginning. Rather, this information could be added to those registries. They keep track of not just the disease-modifying therapies that someone's on, but which specific version of a biosimilar they were on.

Alicyn Magruder, PharmD, BCACP, MSCS: I also think that using postmarketing surveillance is something that as clinicians we could all do better at. I think we all run short of time, and we can’t always gather the most accurate information from the patient to actually say that we agree with it. But I think submitting some of those concerns to postmarketing data would be helpful, too.

Jeff Cohen, MD: Yeah, I agree. Unfortunately, to some extent, the postmarketing safety monitoring is not always perfect, let's say.

Alicyn Magruder, PharmD, BCACP, MSCS: It's not. But I also know that it's hard for our in-clinic team to get the paperwork done when it’s submitted.

Matt Hoffman: No, of course, obviously trying to keep track of that across institutions alone adds an additional wrinkle. So then having to rely on, hopefully having enough time to do so is then just [adds] another power to a different degree.