The MS Landscape and Historical Use of Off-Label Biosimilars

WATCH TIME: 9 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 1

Transcript below. Edited for clarity.

Matt Hoffman: Welcome to this NeurologyLive Roundtable Discussion, where we're going to be discussing biosimilars for multiple sclerosis. We're very proud to partner with the National MS Society on this extremely important topic for clinical practice, and honestly, to the healthcare system at large. I'm Matt Hoffman, the associate editorial director for NeurologyLive, and I'm joined here today by Dr. Jeff Cohen, an MS specialist, professor of neurology, and the director of experimental therapeutics at the Mellen Center for Multiple Sclerosis Treatment and Research at Cleveland Clinic; Dr. Alison Magruder, who is a clinical pharmacist at Mizzou Specialty Pharmacy within the neurology and sleep disorders clinic, as well as an MS certified pharmacist; and Dr. Sarah Anderson, who's a pharmacist, and director of the clinical content and resources of the clinical innovation and strategy team at the National Multiple Sclerosis Society. Thank you all for joining me here today!

Without further ado, let's just jump right into discussion. And I think the proper place to start is just to provide a little bit of context on how we got to this point in the overall treatment landscape for MS. The depth of this landscape has changed quite a bit in the last 5 years, especially as it pertains to this new therapeutic addition. If we could, let's summarize some of those changes for the audience and describe how we got to this point.

Jeff Cohen, MD: Well, so maybe I'll start. We have the good fortune in MS that we actually have, now, quite a wide variety of disease-modifying therapies. The most recent additions include a number of so-called B-cell–depleting therapies. So that includes ocrealizumab, ofatumumab, and most recently ublituximab. There are several new so-called selective sphingosine 1 phosphate (S1P) receptor modulators—these are medications in the family of fingolimod, so there's now 3 of those selective S1P receptor modulators. There are several versions of the fumarates, that's the family that includes dimethyl fumarate, and then we're looking forward, hopefully over the next year, to several new so-called Bruton tyrosine kinase, or BTK, inhibitors.

And then, as some of the earlier medications have gone off patent, we're now starting to see the emergence of follow-on products, so generics and our main topic today: biosimilars. The landscape in MS is changing rapidly.

Matt Hoffman: Absolutely. I think it's set the stage for as you alluded to there, this era generics and comparable products and biosimilars. From the perspective of the clinician and the pharmacist, how did these changes set the stage for that era? Especially now that we've seen this first natalizumab biosimilar approved by the FDA, what are those long-term impacts for the healthcare system and for the market of therapeutics out there? And then downstream, what is the impact for the individual patient? What might they feel as we enter this new era?

Jeff Cohen, MD: Well, the context is that, as everybody has heard, I'm sure, health care costs are quite high and multiple sclerosis is a very expensive disease to care for, and one of the most significant contributors to that cost is the cost of medications. The hope, or one of the hopes, is that with the emergence of follow-on products, generics and biosimilars, that that will increase competition, and ultimately help lower healthcare costs. That that won't happen immediately. When the first follow on product emerges, it doesn't change the price very much, but then as additional ones are added to the repertoire, then there's competition and the hope is that'll drive down costs.

Matt Hoffman: From the pharmacy perspective, I imagine, a very similar thought process here. For you, though, what's your stance on this and your expectation, as we've taken our first step into this realm of biosimilars for MS?

Alicyn Magruder, PharmD, BCACP, MSCS: So, I think in the beginning, we don't see that cost change, like he said. It's more long-term cost savings. In the beginning, it can be hard to navigate how to get patients the services that brand names offer. So even though brand name medications are very expensive, they're also supported by pharma; we have those copay cards, those copay assistance programs and sometimes—I haven't dealt with the biosimilar situation with Tysabri yet, but with my generics—they become less accessible for at first. We know over time, that that those prices will drop. But in the very beginning, sometimes we actually mess with access to the patient. So short-term, we can see some disruption in getting patients therapy, and so I'm interested to see how the biosimilar will work with those copay assistance programs and those kinds of things going forward.

Matt Hoffman: It may take some time, obviously, of course, to see some of those changes, but I do know we have at least a little bit of—not from the approved perspective, but at least some—experience with off-label biosimilar and generic products. I think maybe we should talk a little bit about the clinical history of how those have been utilized in the United States from the clinician and patient experience. I know one of the bigger off-label uses has been rituximab biosimilars and Dr. Cohen, I know you've been quite an early adopter to utilizing those in the US. What's your experience been with those thus far, and what might we be able to learn about the future based on that off-label use?

Jeff Cohen, MD: You know, there actually is—if you think about it—a fair amount of experience with generics, even in multiple sclerosis. We've been using generic baclofen for a while and at times we've used, off-label, other immunosuppressant medications, like azathioprine or mycophenolate. Those are all available as generics and I think most of us are pretty comfortable with that.

Biosimilars become a little bit more complicated because they're more complex molecules and there's always this concern about whether they could be duplicated reliably. But there now are several biosimilar versions of rituximab available and we've been using them quite a lot. We, historically, have used quite a lot of rituximab (Rituxan) to treat MS and other immunologic disorders that we care for, and several years ago, we switched over to using the biosimilar version of rituximab. I would say we've had very good luck with that. The biosimilar versions that we've used seemed to be as effective and as well-tolerated as brand Rituxan

The issue has always been—the more complicated one—is whether rituximab is comparable to the other B-cell–depleting therapies. That's actually the trickier question. And, of course, there's very few head-to-head data comparing the various B-cell–depleting agents but I would say to answer your specific question, our experience with biosimilar rituximab has been quite good and very reassuring.

Matt Hoffman: I imagine that's comforting at least on the from the patient's side of things, that knowing what the product that they're going to be utilizing is the same as that brand name product that perhaps they're more familiar with or at least have some understanding about.