CEimpact Podcast

The Role of Biosimilars in Managing Inflammatory Disease

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With the number of biosimilar products steadily increasing, pharmacists play a central role in ensuring their appropriate use in inflammatory conditions. This episode highlights approval pathways, interchangeability, and real-world challenges pharmacists may face when integrating biosimilars into care plans. You will walk away better prepared to support prescribers, counsel patients, and contribute to cost-effective, evidence-informed therapy decisions.

HOST
Rachel Maynard, PharmD
GameChangers Podcast Host and Clinical Editor, CEimpact
Lead Editor, Pyrls

GUEST
Reemal Zaheer, PharmD, CSP
Pharmacist
Johns Hopkins Medicine


GAMECHANGERS CLINICAL UPDATE SERIES
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PRACTICE RESOURCE
Purchase the Clinical Update Series or this course individually to receive the exclusive downloadable practice resource handout to use as a reference guide to the podcast.

 
CPE REDEMPTION
This course is accredited for continuing pharmacy education! Click the link below that applies to you to take the exam and evaluation:


 CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Explain the role of biosimilars in the treatment of inflammatory conditions.
2. Describe considerations for the pharmacist when evaluating or counseling on biosimilar therapies.

Rachel Maynard and Reemal Zaheer have no relevant financial relationships with ineligible companies to disclose.

0.075 CEU/0.75 Hr
UAN: 0107-0000-26-045-H01-P
Initial release date: 2/2/2026
Expiration date: 2/2/2027
Additional CPE details can be found here.

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SPEAKER_01:

Here on Game Changers, we're all about helping you stay ahead of pharmacy practice. But why stop it listening? You can earn CE credit for this episode and hundreds more by visiting CEimpact.com and logging into your account or creating a new one. Get credit, get inspired, and make your learning count. Hey CE Impact subscribers and welcome to the Game Changers Clinical Update Podcast. I'm your host, Rachel Maynard, and our topic today is so practical and timely, I'm just thrilled to jump right into it. I think we've all seen this explosion of not only biologics but also biosimilars coming to market, with more of our patients using these meds. But that can also lead to a lot of questions, not only because the concept of biosimilars can be a bit confusing for patients and clinicians alike, but also about where these drugs fit into practice and for our patients. So CE Impact is excited to announce a new partnership with Specia, an organization that supports specialty pharmacy clinicians in delivering personalized high-touch care for patients with complex conditions. This partnership is centered on developing high-quality educational programming on specialty pharmacy topics, drawing on Specia's real-world expertise and CE Impact's experience of pharmacy education. As part of that collaboration, we're so pleased to welcome a Specia expert as today's guest to discuss the role of biosimilars in managing inflammatory disease, including clinical considerations, access implications, and opportunities for pharmacy professionals to support optimal patient outcomes. So I am thrilled to welcome our guest, Dr. Remal Saheer. Welcome, Remal.

SPEAKER_00:

Thank you. Thank you for having me. I'm happy to be here.

SPEAKER_01:

Awesome. Well, thank you. And really appreciate your time and taking taking time out of your busy day. Maybe you can just share a little bit about yourself and what your background is, what your current role is, and why you're interested in this topic.

SPEAKER_00:

Yeah, certainly. So again, my name is Remal, and I graduated from Virginia Commonwealth University School of Pharmacy in 2021 and then went on to complete a PGY1 community pharmacy residency at Johns Hopkins Care at Home. Since then, I have been a clinical coordinator pharmacist with Johns Hopkins Specialty Pharmacy, primarily in the neurology space, where I'm involved with the initial onboarding of our specialty patients, like helping them with the initial prior authorization approvals, financial assistance, as well as the education for the specialty medications and ongoing monitoring for the medications as well. Outside of my role at Hopkins, as you mentioned, I'm also a part of Specia. I am a clinical pharmacy consultant with Specia, where I serve as a subject matter expert for several specialty pharmacy disease states like inflammatory conditions, neurology, cystic fibrosis, solid organ transplant. So just a little just a little bit about myself.

SPEAKER_01:

That's great. I mean, I think you've got just the right experience and expertise that we're looking for for this discussion. I know this is not an area of expertise for me, so I'm very excited to learn from you and hopefully our listeners can too. And, you know, as you mentioned, inflammatory disease is one of your areas of expertise. And we are going to focus our discussion today on biosimilars for inflammatory disease and using that as sort of a broad umbrella term, but it can include things like autoimmune diseases like rheumatoid arthritis and psoriasis and lupus, as well as inflammatory bowel disease, including Crohn's disease and ulcer tip colitis. But I think it makes sense to sort of narrow in on these because it really applies to a wide variety of biosimilars that I think our listeners are often seeing and maybe dispensing. So I just to sort of set the stage that way. But I have, you know, in opening up the discussion, I threw out the terms biologic and biosimilar. And these terms I think can be confusing. They do have different meanings. And just laying that groundwork again with some of these definitions, I think will be really helpful so that we're speaking the same language here. So could you help us define those terms biosimilar, biologic, and what they mean and how they're similar or different?

SPEAKER_00:

Yeah, certainly. I think it's it's actually a great idea to start off with defining what a biologic is before we can understand what a biosimilar is. Right. So basically, biologics are these complicated large molecules that are made from living cells. So think about like monoclonal antibodies that are made from a bacteria or a yeast cell. And as you can imagine, it's a very complicated process to purify these products, to manufacture them. So it's highly time-consuming, highly complicated, and very lengthy and pricey thing to create. When we talk about biosimilars, these are medications that are highly similar to a biologic or what we call a reference product. So biosimilars have to go through extensive studies to show that they are equally effective, equally clinically effective to the reference product or the biologic. So when we understand the difference between those two, I think it becomes easier to talk about the news, the news we have right now of like all of these biosimilars coming to market.

SPEAKER_01:

Right. Okay, so you brought up a few important points there, I think, too, just the concept of these products. Both so biosimilars are a type of biologic, right? They are also a biologic, but they are similar to the reference product biologic. So I think that's where it can get a little confusing, right? Is you have their reference product, which is sort of like when you think of your brand name traditional product that's approved, it's the first one that comes out, it's the reference biologic. And then you can have biosimilars to that biologic, similar to how we have generics for those traditional brand name drugs. Is that a fair comparison or exactly?

SPEAKER_00:

So if you look at the name biosimilar, so it is supposed it is similar to the biologic, but I will say that I don't necessarily put them in the same category as a generic medication. And I think it's also important to define what a generic is and how it compares to the biosimilar. Uh, because I I personally have had patients ask a lot of those questions of like, oh, is it like a generic of the brand name or something? So there it it conceptually, it it is similar, right? Like you have a reference product and then you have a low-cost alternative now called a biosimilar, right? But the way it's different from typical generic is that generic medications are small molecule medications that are chemically synthesized. And it's it's like following a recipe, right? Like you put in all the exact ingredients and you get a chemically synthesized medication called a generic fits brand. Alternatively, a biosimilar is not the exact same thing as its reference product. And the reason for that is these are medications that are in a living, that are being made in a living organism, right? So there's like a biological process involved which brings in natural variability between batches of the medication. So even if we talk about a true biologic, different batches of that same biologic could have some differences between them. But the way these biologics and biosimilars are made is that there has to be a certain threshold that they have to stay within in order for them to qualify as biosimilars. So as long as they meet that threshold, they they are considered biosimilars and but they will still have a little bit of the differences from the reference product.

SPEAKER_01:

Excellent point and excellent excellent clarification there. I think that the way you explained it, I think makes sense to us as clinicians. But for patients, when you hear that word variability, that I think can start to raise some questions. But I remember hearing that even within traditional drugs and generic drugs and the manufacturing, each each batch within those can have their own variability, slight variability too. So, how would you reconcile that for a patient who, if if they hear this concept of, well, they're not, they can't be identical because of the way they're manufactured? How would you address that concern?

SPEAKER_00:

That's a great point. And I feel like it's definitely a point of confusion for a lot of patients, right? Um, when we tell them, oh, it's it's a little different, but it's the same. So when it comes to generic medications, the the actual active ingredient is exactly the same as the brand name. There may be other like inactive ingredients or excipients that may be different than the brand name, uh versus in a biosimilar, again, like we're using the same kind of living cells for these medications, but because of the way it is formed biologically in nature, there can be some differences there within the actual ingredient. Yeah. Okay. The other point go ahead. So go ahead. I actually like to think about a specific analogy when I come to define generics versus biosimilar. So uh I imagine generic medications as like the identical twin to their brand medications, versus biological biosimilars are like the highly similar siblings to the reference product.

SPEAKER_01:

Yeah, that's a good useful comparison to keep in mind. But in terms of the clinical effects and safety considerations, that highly similar is enough that patients wouldn't expect necessarily to see differences between the reference product and the biosimilar. Would you say that's the case? Or how how would you explain that to a patient or clinician if they were asking that?

SPEAKER_00:

Yeah, the reason we use the terminology highly similar is again going back to the way these medications are made, is we can't 100% say, even within the same batch of the medication, that hey, it the every single like batch is gonna be, molecule is gonna be the exact same thing. But when we talk about highly similar, we're talking about studies, extensive studies that have been done to actually approve the medications based on their clinical efficacy as well as the safety profile. And that is when we are able to say that, hey, this biosimilar is actually approved for this specific biologic. So it's not like a random term that's being thrown out there. There's like extensive studies that are showing the effectiveness and the safety of the biosimilar before it comes to market.

SPEAKER_01:

Right, right. Okay. And and just to specifically quote some of the FDA language, as you said, it's highly similar to and no clinically meaningful differences in terms of safety, purity, and potency is, I think, the language I always go back to because it it is confusing. It can be hard to like wrap your head around. And so there's very nice specific language on the FDA website about that. And this what sticks with me is this no clinic clinically meaningful differences in terms of safety, purity, and potency that I think is helpful to have as a as a talking point for patients in particular. Yeah, for sure. Yeah. Okay. And you did sort of touch on the the regulatory process and and the clinical studies needed to have these biosimilars approved. Is there anything else that we want to hear about there? Like any any more details about how these biosimilars are approved and how they're compared to the reference product or any.

SPEAKER_00:

Yeah, I can certainly talk a little bit about the kind of studies that are done to that show the evidence of the biosimilars and their comparison to the reference product. So basically, biosimilars use this approach called a totality of evidence approach, which basically means there has to be a comprehensive review or several kinds of studies that have to be done to show that the biosimilar is highly similar to the biologic that it is getting the approval for. The first step in that process is analytical studies. So these are studies that have to show structural as well as functional similarities between that biosimilar protein. It has to be structurally and functionally similar to its biologic. Okay. If if it's if it if it is approved at that point, it then undergoes additional studies like animal studies, toxicology studies, pharmacokinetic studies, and pharmacodynamic studies. These are studies that are looking at how this biosimilar is getting absorbed in the body, how it is actually working in the body, how our bodies are reacting to the medication. So we are doing all of these studies to better understand how this product relates to the biologic. Once we have all of these studies done, there are additional studies, like clinical studies, that have to show no meaningful difference between the biosimilar and the biologic. So as you can imagine, it's FDA states it's an abbreviated pathway, which can be a little confusing for patients, right? Like it makes it seem like it's it is like maybe like a quicker process or something. But I will say that it is still a very extensive process that these medications have to go through. It may not be as expensive as like a biologic itself, because that's when we're working from scratch, right? Like we're actually developing the molecule. We're actually doing all of those studies to actually see if the medication works or not. But with the biosimilar, we know that this medication works. We're just going through these additional studies to make sure that it compares and is as effective as the biologic, which makes it a little bit abbreviated compared to the actual biologic.

SPEAKER_01:

Sure, sure. Yeah. And again, I'm thinking about generic drugs, also, their abbreviated new drug applications is what they submit for their generic approval. So it is, it's that same term abbreviated, and doesn't necessarily mean a fast track. It means, you know, just a different approval process. But that's also so critical in helping to lower prices, because one point you brought up earlier was that these drugs are very expensive, biologics are very expensive, partly because of the development process, reachers research and development process. So even though, you know, we're abbreviating biosimilars can still be also quite expensive, although lower cost than the reference biologic, but simply because of this complex manufacturing and and development process that's needed, right?

SPEAKER_00:

Exactly. Yeah, the considering how extensive these studies are and how how expensive they can be, we we are seeing like several thousand dollars that are that are that these drugs are marketed at. But in comparison to the reference product, it is a significant difference in the price.

SPEAKER_01:

Right. But still, yeah, thousands of dollars they can be. I saw one stat that it said as of 2024, biologic medications make up only 5% of prescriptions in the US, but account for 51% of total drug spending. And I think I've seen similar stats over the years around that. So it is pretty amazing to think about, even though these drugs are not as widely used necessarily, they do account for a large bulk of the drug spend, which is exactly speaks to that process that you talked through. So yeah, yeah. Okay, so let's move on to interchangeable biosimilars and introduce a new term there because that is another sort of layer of development that that is happening. So, can you talk a little bit about what an interchangeable biosimilar is and what that process looks like for those to be approved?

SPEAKER_00:

Yeah, certainly. So, interchangeable biosimilar is basically a biosimilar that meets all of the requirements as a biosimilar. But in addition, it also has to go through switching studies where it has to prove that switching between that biosimilar and the reference product does not indicate any kind of loss of efficacy of the medication. And I would like to highlight that this is not a status that FDA grants to every medication. It's not like an automatic designation that the biosimular gets. Manufacturers actually have to do these switching studies and then apply for this interchangeable status in order to be considered for the interchangeability. With that, it actually is a regulatory designation. It's not like a clinical judgment or statement saying that an interchangeable biosimular is better than another biosimular. It just means that it just has to go through additional steps to prove the interchangeable status, which is then granted. And once a biosimular is interchangeable, pharmacists can actually make that substitution without asking the providers first. So again, like it's more of like the regulation, not like a clinical judgment.

SPEAKER_01:

I and I think that's such an important point, but again, very confusing because as you said, it this interchangeable designation is what allows pharmacists to automatically substitute in many states. Again, it all depends on state law, but that designation, which not all biosimilars have, can be a deciding factor in whether you can automatically substitute or not, depending on your state. So again, how would you help reconcile that with, you know, people thinking that, oh, interchangeables are somehow different clinically than a non-interchangeable biosimilar? How can we help explain that to even another clinician, a colleague, what is the difference? You know, how would you how would you reconcile that?

SPEAKER_00:

Yeah, no, that's a great point. And I feel like this is more so, as you mentioned, for the clinicians than patients, because I think at a patient level, like biosimilar is a biosimilar. Like they they may not be worried about too much about like the interchangeable status or anything like that. But I think when we talk about interchangeability, it actually is if if we understand what the definition is, which is the fact that it's it is a biosimilar that was submitted with additional paperwork to get that interchangeability status. Uh we we can then it can actually help us on the pharmacist level to, you know, help the transition process a little bit more smoother for our patients, especially if it's a medication that has that interchangeability status and it is preferred by an insurance formulary. Like we don't have to go into that additional step of like reaching out to the provider asking them to send a new prescription. Um, it is something we can change on our own without needing those additional steps. So again, like it it tells us nothing about a clinical status of the medication, but rather it just helps us in in the operations of the pharmacy, if that makes sense.

SPEAKER_01:

Yeah, exactly. Those sort of practical dispensing considerations and as you say, insurance considerations too. So clinically, from your perspective, if you were faced with if you had either a patient being prescribed a non-interchangeable biosimilar or an interchangeable biosimilar, is there clinically any difference to you when talking with a patient or thinking about that particular drug in place and therapy? Is there any sort of like outside of the additional paperwork that was submitted to get that status, do you have any different view of those two different products?

SPEAKER_00:

I do not. So again, like I think it's important to note that all interchangeable products are biosimilars, but not all biosimilars are interchangeable. So it's literally just a matter of like understanding if if we have an interchangeable biosimilar, we don't have to, you know, reach out to the initial every single time. Uh that is a substitution we can make as pharmacists. But in terms of like the clinical aspect of things, I have no difference in my head when I think about a biosimilar versus an interchangeable biosimilar. Similar. Yeah.

SPEAKER_01:

That's great. That's great to hear. And I think reassuring for us who maybe aren't as familiar with this, just to know that because what I care about clinically is whether it's going to have any difference for the patient. And so if if you know if that's not something we're concerned about, then it is it's obviously having the interchangeable status streamlines the dispensing and practical aspects, but not necessary from a safety efficacy sort of perspective.

SPEAKER_00:

Exactly. And I feel like an added layer there is again the peer relationship, right? Like a lot of depending on which insurance prefers which product on their formulary, like it's it is not even in our control to decide if we want to dispense an interchangeable biosimilar or just a regular biosimilar. So a lot of it is coming down to like the peers and what they are choosing to put on their formularies. But again, like in terms of dispensing and having that conversation with patients, we're not having different conversations. Um there at the end of the day, they're all biosimilars.

SPEAKER_01:

Gotcha. Okay, that's great. Great to wrap up that sort of concept. And if we use that to sort of transition into some of the practical considerations more broadly that our listeners might be facing when managing biosimilars, they may or may not be dispensing these meds themselves. They might be working with a specialty pharmacy or specialty pharmacist. And again, I think that term can be sort of nebulous. So maybe you can talk through a little bit what a specialty pharmacy or pharmacist is doing and how they work with other pharmacists, other clinicians. What does that whole process look like?

SPEAKER_00:

Yeah, certainly. So specialty pharmacy is or pharmacists are basically taking care of these specialty medications that are treating chronic, complex disease states like inflammatory conditions, and in the neurology space, we have multiple sclerosis, we have cystic fibrosis. These are very complex medications in terms of their usage. So they require special handling, monitoring, and they have very different dosing schedules. They have the administration techniques can look very different, the pen devices can look very different. And at the end of the day, these are very high cost medications just because of the complexity that's involved. So it does require special training and special resources to work with these medications, which is where the specialty pharmacists come in. So we as specialty pharmacists are involved with the prior authorizations of these medications. So again, with them being very high cost medications, they're usually not the preferred agents on an insurance plans formulary. So they have to go through these additional prior authorization steps. There's benefit investigation as well as financial resources that we're helping these patients with, because again, with the high cost, we have patients who may not be able to afford the medications, or even if their insurance is covering the medication, they are still left with very high co-pays for the medications. So just with the financial aspect, but then also the initial onboarding and helping with the initial education, because as you can imagine, if a patient is, they've never done an injection and now they're having to do to take a medication on their own, there's a lot of hesitation. There's a lot of like fear in the beginning. Um, so just helping patients with that initial education and providing resources in terms of instructions and like how to use the medication, videos that they can watch. And also ongoing monitoring is a very big part of like what we do. A lot of these medications require lab monitoring or just looking at from the adherence standpoint, making sure that the patients are getting their medications on the dosing frequency they're supposed to get them. All of this requires very close communication with the peers as well as the prescribers, because again, like it's a it's a it's a big web of things that are coming at us. So we got, you know, work with the providers very closely to help them get the medication approved. Because again, like the providers, they they're dis they're prescribing the medications, but when it comes to a dispensing, there are so many added layers we have to get through before we get to the actual dispensing part.

SPEAKER_01:

Right. I think that's a great overview and the concept of communication and collaboration, not only with the patient, but also other colleagues. And as you say, with the payer, there are these sort of extra layers involved, and that takes more time. And so that's where the the dedicated staff focused on on that specific process and product is also helpful in the for all of us, I guess.

SPEAKER_00:

Um, and I feel like we as specialty pharmacists are sitting right in the middle of all of this because again, we are the ones communicating with the patients, we are the ones like collaborating with the providers, we are the ones, you know, scanning the formularies to see which product is preferred for each insurance plan. So it takes a lot of like collaboration, but I do think our our role as specialty pharmacists is so critical because at the end of the day, everyone is trying to help patients and we are at that last step before the patient gets their medication.

SPEAKER_01:

Right. And how how do you often collaborate with outpatient pharmacies, maybe you know, community pharmacies, ambulatory care pharmacies, pharmacists collaborating with one another? What does that look like?

SPEAKER_00:

Yeah, so that's a good question. Because these are specialty medications, a lot of time based on like insurance formulary formulary restrictions, patients may be required to fill with other external pharmacies, right? So because I work closely with Johns Hopkins, specifically with our providers, we help out with the initial approval of the medications, but then work closely with the external pharmacies to make sure patients get their medications dispensed. So a lot of times it is a like back and forth communication with these external pharmacies to make sure that the medication is approved, the prior authorization has, you know, been granted. For a lot of these medications, there are like a loading dose and a maintenance dose. So making sure that insurance understands what indication the medication is getting approved for. So we can then dispense the appropriate amount of pens accordingly. So a lot of uh communication with the external pharmacies for sure.

SPEAKER_01:

Right. More communication. And so, yeah, that's it's a it's important for us all to be on the same page about what the products are, what their indications are, the uses, the biosimilars versus you know, reference and understanding all of that so that some of that doesn't get in the way of that streamlined, hopefully, process. In terms of other practical potential barriers or considerations, um, and you know, thinking about switching maybe when a new biosimilar is approved. Can you talk through how our listeners can work through some of those challenges, maybe regardless of their role or what they might need to be aware of if a patient is going through that process?

SPEAKER_00:

Yeah, I think that's a great question. I would say the first thing we as pharmacists need to do is educate ourselves. Um, again, biosimilars are here to stay. They're not going anywhere. So it's an exciting time for the inflammatory space in general. Uh, but I will say that biosimilars are not new. We have had biosimilars in other spaces. It's just hitting the market in the inflammatory space within the last two years or so. So they're not new. Um, it's good for us to learn about the biosimilars as pharmacists so that we can better educate our providers as well as patients. The more confidence we have in how these medications are made and how they can be similar to the biologic, the better we can help patients and providers understand. There's a lot of fear patients have when they're switching to some of these biosimilars. Because again, imagine if you have a patient who has been on the biologic for several years and it has been working perfectly fine. And all of a sudden, their insurance no longer covers the biologic because they now want the patient to be on a biosimilar. As a patient, that can be very scary and overwhelming, especially when you have a condition that impacts you on a daily basis. Now you're worrying about if the insurance is going to need another prior authorization for me to switch over. If it, if I do switch over, how long is the medication approved for? And how often do I have to go through this process again? You know, it's it's very difficult for patients. So we as pharmacists can actually be the ones who can help them through that process. When we know we have biosimilars coming to market for different disease states, being proactive about what the process is going to look like once we do have access to these biosimilars. Um, so making sure that we have a way to communicate that change with our patients and the providers, looking at the formularies to see which insurance plan prefers which biosimilar. So knowing all of that information can help us be proactive rather than reactive when it comes to biosimilars. And I think that can down the line help patients with a lot of the uncertainty that they have to experience. Again, like using confidence-based language, having that neutral, confident approach to this change, because it regardless of if I'm confident or not in this change, the change will happen because this is like insurance-mandated change that would be happening. But I, as a pharmacist, can make this process easier for my patients when I know why we have these biosimilars, what the purpose is and how they are, you know, working for these patients. I think like a lot of it is the mental game when it comes to speaking with the patients. Like when we know what we're talking about, when we know we're confident in what we're dispensing, the patients will see that and they will have lesser of the fear and the confusion when it comes to biosimilars.

SPEAKER_01:

I I think you you summarized that really well and calling out the fact that these are complex conditions, complex drugs, and there's definitely not surprising that patients may have uncertainty about this, especially if they have been on something for years, as you said. And so helping with the confidence, helping them feel comfortable and confident with it. So I'm curious, you know, if you, if I was a patient and you were to give me a 30-second, you know, sort of elevator speech summarizing all of that and helping me feel comfortable, how would you, how would you frame that? Like what how would you go into that conversation? Because I feel like even having some of those, those words and phrases that we can, you know, use when come when talking with patients ourselves, and you do this on a daily basis, I'd love to know like how you approach it and what sorts of things you would say.

SPEAKER_00:

Yeah, if I had to, and I I feel like I have done this with numerous patients at this point, considering we have had uh several biosimilars already on the market. So, what how I like to approach it is letting them know hey, we have a medication that works very similarly to the medication you're currently on. Um, it has clinically shown to be as effective and as safe as your current medication. However, it is a lower cost alternative to what you're on right now. So I think that kind of like ease the eases the patient into understanding the role of biosimilars, but also letting them know that at the end of the day, me as a pharmacist, I am trying to help them when it comes to, you know, the cost-related concerns or any insurance-related concern. So setting it off by saying that, hey, it is a medication that is working based on the evidence that we have, very similarly to what you're already on, but it is a lower cost alternative, definitely helps.

SPEAKER_01:

Yeah, yeah, yeah, absolutely, because everybody, nobody can argue with lower cost, right? Hopefully not.

SPEAKER_00:

Yeah, especially when it comes to the biologics and the and the price that we see for these medications. Absolutely. It is it is insane.

SPEAKER_01:

Right, right, absolutely. Okay. That's a that's a good way to frame it, I think, too. Very helpful. So we've we've talked about sort of those practical considerations, but I do want to talk more about the clinical side of things and especially with these inflammatory conditions specifically. And again, we could spend probably three hours on this topic alone, just biosimilars for inflammatory conditions. But if we were to sort of summarize some high-level concepts with biosimilars for inflammatory conditions, so maybe some of the top counseling points you you think of with these meds or how these meds work, or you know, just generally place in therapy for these biosimilars for these inflammatory conditions, maybe you could just summarize it to a few key points for our listeners to be aware of.

SPEAKER_00:

Yeah, of course. So biosimilars are, again, because they are working the exact same way the biologic is, the place in therapy does not change for these medications. Okay. If a patient is on a biologic, they can certainly switch over to a biosimilar. In terms of the mechanism of action, that is exactly the same as well. The way it's working in our body, um, the receptors that medication or biosimilar targets is the same as the reference product. The dosing frequency is also the same for the specific indication the medication is approved for. I think one difference that we do go over with our patients is the fact that the pen, the formulation of the device can look a little different. So, for example, if a patient was previously using a prefill syringe and is now switching over to a biosimilar, that does not come as a syringe or the other way around where they were using a pen injector, but the biosimilar they're switching over to does not have a pen formulation. So the administration technique can look a little different, right? So just going over the administration technique, making sure patients understand the difference in terms of how to use the injection, storage conditions, again, a lot of these medications are stored in the fridge. So that doesn't change. But the fact that the duration of the medication being out of the fridge and the stability of the product can look a little different depending on the biosimilar versus the biologic. Um, and then one thing I do like to tell patients is even though this is a biosimilar, these drugs actually do have their own copay programs, which can be very helpful for a lot of patients. So that's another difference between a generic medication and a biosimilar. Where for if a generic medication comes to market, there's no financial uh support available. But for these biologics, they actually do have their own copay support program. So if an insurance prefers the biologic and a patient is left with copies, there are certainly copay programs available for patients to enroll in, which can further, you know, help them with their with their cost of the medications.

SPEAKER_01:

That is a great point to keep in mind. And as you say, a difference between biosimilars versus generics, in addition to some of the other things we talked about before. But yeah, that's another, can be another compelling argument too, to help with that further help with that cost assistance. And I think you laid out very nicely how in in terms of place and therapy, mechanism, all of those sort of clinical factors, you would not really expect any differences regardless of the condition that is being managed. But some of those practical considerations, like the device, could be different storage considerations. Yeah, I think you you summarized that really well. You had mentioned that in the inflammatory disease space that we're starting to see more biosimilars coming out in the last couple of years. Maybe you could give some examples of that or like why that's why that's evolving. Is that because biosimilars for inflammatory conditions came out later than for other conditions? Or maybe you could speak a little bit more about that?

SPEAKER_00:

Yeah, certainly. So the reason I speak about inflammatory conditions is because for the longest time we've had brand name medications or biologics for inflammatory conditions. And if you look at the stats, the one of the products at a Limumab is actually one of the most dispensed specialty medications in the world, and not just in the US, in the entire world. So for over 23 years, at a Limumab brand has been dispensed, and we we have not had any alternatives to that. With the exclusivity patent expiring for that medication in 2023, opened up opportunities for other drug companies and manufacturers to come to market with their biosimilars. Again, financial incentive is there, right? Like you're going through this abbreviated pathway that allows you to bring similar medication to the market without having to go through the extensive studies that a biologic would, which saves you, you know, resources, which saves you time, which saves you money. And then you're actually pricing them at a lower cost, which saves patients money as well. So it's a it's a nice time that we have now that we have all these patents expiring and we have biosimilars coming to market. And most recently, we have Ustakitimab, which is primarily used in the GI space. Uh, we we're having biosimilars come out for that. And I think it's it's not stopping here, right? Like we have this is this is like the next step in the specialty world where we will have more and more access to these biosimilars. It's more of like, are we prepared to tackle them? You know, it comes with a lot of dispensing changes, it comes with a lot of, you know, proactively making changes within the pharmacy um to better able to support our patients because uh sooner or later we are gonna have to switch patients over to these biosimulars because a lot of the changes are insurance mandated. So it's it's it's it's a timely change that we have. It's exciting, it's upcoming, and I know it's the beginning and it's it's it's continually gonna grow grow um with with seeing a lot of other products coming to market in the next few years.

SPEAKER_01:

Yeah, that's a that's great perspective. I I know I've seen just in the past couple of years, as you've said, I didn't realize it was only 2023, but thinking about Adalumab and all the bio, it seems like I I think there's like 10 plus biosimilars that have been approved for Adalumab alone. And I think as you say, we're gonna continue to see this. And so being educated about what the differences and similarities are, and that may even vary from biosimilar to biosimilar, too. So as formulas change every year or patients change insurances, it's so important to keep up with each particular product and how it's changing, and also to, as you said, being aware of which new biosimilars are expected, especially first-time biosimilars, so that we can prepare patients for some of those changes. And also, you know, just having resources references to be able to look up information. We didn't talk about the purple book, is a great resource, I think, for pharmacists to be able to look up. If you looked up at a Limimab, for example, you can see all of the products that are bio that the reference product, the biosimilars, as well as those that are interchangeable specifically. So for those who haven't used it, it's a really very, very easy to use, in my opinion. Like I, you know, just browsing around on it, it's it's quite easy to sort of see some of those differences. But any tips or tricks from a the perspective of staying on top of some of these changes or or how pharmacists can educate ourselves? Any any thoughts on that or tips?

SPEAKER_00:

Yeah, I think you brought up a really good point about the purple book. It's a great resource for pharmacists to be able to access the biologics, uh, the status for the biosimilars, the interchangeable status. I also think making sure that a lot of times our patients are also very well informed and aware of like upcoming changes. So just making sure that we stay in touch on top of everything in terms of like the insurance formula changes, if a patient lets us know, or if we have, you know, connections with the with pairs and we we find out about these upcoming changes. I think all of that can better prepare us for. Any new biosimilars coming to market and like the steps we can take now to help ourselves down the line.

SPEAKER_01:

Yeah, absolutely. So that's about all the time we have. Would you like to wrap up with it's our game changers podcast? So we we tend to end with a question around what do you think is the game changer on this topic? And what would you like our listeners to walk away with when it comes to thinking about biosimilars for inflammatory conditions broadly?

SPEAKER_00:

I would like to say that biosimilars are no longer new. They are established evidence-based therapies that have been approved and continue to get approval. They play a critical role in improving access to our patients. So we as pharmacists are very central to these upcoming changes that are happening in the inflammatory space as well as specialties in pharmacy in general. If we are better prepared to be able to handle these changes, we can be equipped and we can be create support for our patients and providers when it comes to, you know, these changes. It's it's we we are dealing with therapies that are as safe, as effective as their reference products. So being able to, you know, understand that and provide that same confidence to our patients and providers is very important.

SPEAKER_01:

Yeah. I I think you that summarize it so well in terms of that's one of the big roles we are trying to achieve as education providers, is helping ensure all clinicians that we all feel confident, comfortable ourselves, and then can pass that along to our patients too. So I think you summarize that really well. That confidence and and knowledge is sort of the first step in helping patients feel the same. Excellent. Well, thank you so much, Remel. I really appreciate your expertise on this. And thank you again for your time and and chatting with us today.

SPEAKER_00:

Thank you. It was a pleasure to be here.

SPEAKER_01:

Great. So, listeners, be sure to claim your CE credit for this episode of Game Changers by logging in at CEimpact.com. And as always, have a great week and keep learning. I can't wait to dig into another game changing topic with you all next week.