ES

Switching to a Biosimilar 

Since a number of biosimilars to Humira became available in 2023, many more arthritis patients have become aware of these drugs, and many are being required by insurance to switch to one. In this episode, a patient and a rheumatologist will discuss their experience with biosimilars and how they are addressing concerns.

This episode is brought to you in part by Boehringer Ingelheim.

 

Show Notes

Biosimilars have been used for rheumatic diseases in the U.S. since 2016, but it wasn’t until 2023 that many arthritis patients became aware of them. Until then, they were available only in infusion form. Now, a number of biosimilars to adalimumab (Humira), which are self-injected, are available.

Now, insurers and pharmacy benefit managers are requiring many people to switch to a biosimilar. Although they are required to have no clinical differences from the original biologic, many patients have questions and concerns about them. In this episode, guest host Cristina Schaefer is joined by biosimilars expert Dr. Angus Worthing and Rick Phillips, a patient who has been using a biosimilar, to share their experience and knowledge about these drugs.

About The Host

Cristina Schaefer (Houston, Texas)
Read More About Cristina

About Our Guests

Angus Worthing, MD (Washington, DC)
Read More About Dr. Worthing

Rick Phillips
Read More About Rick

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Full Transcript:
For release 5/7/24
 

PODCAST OPEN:           

You’re listening to the Live Yes! With Arthritis podcast, created by the Arthritis Foundation to help people with arthritis — and the people who love them — live their best lives. This podcast and other life-changing resources are made possible by gifts from donors like you. If you’re dealing with chronic pain, this podcast is for you. You may have arthritis, but it doesn’t have you. Here, learn how you can take control of arthritis with tips and ideas from our hosts and guest experts.

 

MUSIC BRIDGE

 

Cristina Schaefer:

Welcome to the Live Yes! With Arthritis podcast. I'm your guest host, Cristina Schaefer. I'm a volunteer in Houston, Texas, an arthritis warrior who has been living with rheumatoid arthritis for 19 years. You might remember me from the two-part back pain podcast episodes and the health disparities podcast episode we did last year.

 

Today, we're talking about biosimilars. These drugs have been used for rheumatic diseases in the U.S. since 2016, but it wasn't until last year that many arthritis patients became aware of them, because they had been available only as infusions in the U.S. Last year, a number of biosimilars to Humira, which are self-injected, became available, and now insurers in many cases are requiring people to switch to one of these biosimilars. Nearly a year after most of them were introduced, we wanted to find out how they are being prescribed and received, what concerns are being raised and what patients and physicians are seeing as the pros and cons of biosimilars.

 

Today, we have Dr. Angus Worthing and Rick Phillips joining us in this conversation. Dr. Worthing is a private practice rheumatologist at the Arthritis and Rheumatism Associates P.C. in Washington, D.C., and a volunteer faculty member at Georgetown Medical Center.

 

Rick Phillips was diagnosed with type one diabetes in 1974 and rheumatoid arthritis in 2000. He writes extensively for several arthritis- and diabetes-related publications and social media platforms, and Rick is also a recipient of the Arthritis Foundation's 2024 Champion of Yes Award.

 

Dr. Worthing, can you tell us a little bit about yourself and your interest in biosimilars?

 

Dr. Angus Worthing:

Sure. Thanks, Cristina. I'm a rheumatologist in private practice, so I see patients every day who take biologics for their rheumatic diseases. I see patients struggling with some of the high costs of the system that biologics incur, and so we're hoping that biosimilars will bring lower-cost options and increase access for patients.

 

But also, my interest comes from being a volunteer, like yourself, in advocacy for the American College of Rheumatology, which, as you and some of the listeners may know, it used to be sort of a sister organization with the Arthritis Foundation. Several years ago, I was the chair for the Government Affairs Committee at ACR when a lot of these questions and FDA approval pathways for biosimilars were being elucidated. So, I have an interest in both taking care of people who take these drugs, but also on the advocacy side, to make sure the pathways are working well.

 

Cristina Schaefer:

And we thank you so much for being involved. It really makes a difference to have health care providers involved. Can you refresh us, Dr. Worthing, on just some of the basics? What are biosimilars? And how do they differ from generic drugs? Because some people think they're the same thing as a generic.

 

Dr. Angus Worthing:

Probably one of the easiest ways to describe biosimilars is to say that they're generic biologics, but they're really not. Generics are shorter, simpler chemicals, and so it's a lot easier for a company to prove to the FDA that medication should be used in the United States. Biosimilars, however: much larger, complex, with different folding because of the larger molecule, and they're made in a living cell, which is an environment that's not 100% controllable, so some things might be different from one molecule to another.

 

So, the FDA approval pathway is different for generics and biosimilars in that, instead of simply proving that a drug is the same chemical, which is a sort of simple process with generics, instead it's a much more involved process, involving analytical methods, which are like taking pictures of the structure and assessing the function of the drug.

 

Also, using it in a clinical trial, in most cases at least one clinical trial, in people, to make sure that the drug is safe and that it acts the same as its reference biologic. So, there are a number of differences between generics, but the same overall mission, which is to provide competition and reduce the price and increase access to the medications.

 

Cristina Schaefer:

Thank you. Now, biosimilars have been used in Europe for years. Why has it taken so long to get them in the United States?

 

Dr. Angus Worthing:

That's a great question, and there's two main reasons why America lagged behind Europe in using biosimilars. The first was that the European drug approval pathway came out in 2005, but the FDA in the United States was only given authority to approve biosimilars in the Obamacare legislation in 2010. Then after that, when biosimilars started becoming approved by the FDA, they weren't yet ready for market because of court cases and litigation between the original manufacturers and the biosimilar makers.

 

We now are at a place where we have lots of experience with a few biosimilars in rheumatology, but it took a while. And a little bit later, after the European experience. One benefit of being sort of second, or being late, after Europe was that American rheumatologists and patients were able to be reassured by all the data coming out of the European experience, that things were going as planned. And so that's data that I still use today, talking to people about biosimilars.

 

Cristina Schaefer:

Excellent. Now, Rick, can you tell us about your experience with biosimilars? When did you make the switch and why, especially since your existing medication was working so well for you?

 

Rick Phillips:

I became familiar with biosimilars back in 2016, when I attended ACR, the American College of Rheumatology, meeting. And I was really skeptical of the viability of using them. But I became more and more educated about them. And in 2018-19, I became convinced that it was a good time for me to switch. So, I went to my rheumatologist, and I asked her if I could switch, and she was skeptical. She said, "You know, you're doing really well on your reference product, and I don't really think that it would be wise to switch here." And frankly, my wife was skeptical as well.

 

But I persisted, and finally, in 2022, I was able to switch, and I haven't looked back. Now, the reason I switched was because I just believed that we have an opportunity to lower health care costs by using biosimilars. And ultimately, that should allow more patients to be able to access biologics when, in fact, I'm afraid that if we stayed on the course of biologics costing so much more that there would be reduced access. And I'm just convinced that the best way forward is biosimilars.

 

Cristina Schaefer:

How did the biosimilar work for you? Could you tell any differences between the reference biologic and the biosimilar?

 

Rick Phillips:

Not at all. It was completely without a difference. It just flowed, one to another. I was actually expecting that I would still find some difference, even though I was feeling positive about things. I didn't find anything like that. Worked just like a charm.

 

Cristina Schaefer:

OK. Dr. Worthing, biosimilars, as we heard earlier, are required to have no clinically meaningful differences from the originator product. Are we finding that people are seeing biosimilars as safe and effective, as Rick has experienced?

 

Dr. Angus Worthing:

What we're noticing is that, both in data that are coming out and also my patients' experience, they are having the same expected experience with biosimilars that people on a reference biologic have, and people moving from reference to biosimilars are having similar experiences. Most of our experience in rheumatology is from the infliximab biosimilars, which was Remicade and now there are several other biosimilars to that compound, a drug given as an infusion in the office. And now we have more experience, like Rick, in people taking a biosimilar to rituximab, Rituxan biosimilars.

 

What we're just starting now is experience with moving from Humira, which is adalimumab, to other biosimilars. And while I have prescribed dozens of Hyrimoz, mostly prescriptions for people moving from Humira to the biosimilar. For the switch date was just a couple of weeks ago for most people who were in the process with moving from CVS Caremark. I haven't actually seen a person back yet after they have moved to Hyrimoz. So, most of my experience in taking care of people is with the other two biosimilars, and they've worked out just as well as expected.

 

Rick Phillips:

It really has a lot to do with two factors. The first factor is the positivity that a person brings to the process. The more positive they are that this will work and that it will be viable for them, the more likely it is to work. That's not a surprise. And the second factor is where they are in the treatment process. Sometimes, biosimilars get prescribed for people who are already having difficulty with the reference product. And by and large, if a person is not having good success with the reference product, they're not likely to have really great experience with the biosimilar in the same category.

 

Cristina Schaefer:

So, don't go to the biosimilar looking for a difference or an improvement, I guess we should say.

 

Rick Phillips:

Well, I think that's what most people find.

 

PROMO:

Over the past seven decades, the Arthritis Foundation has invested over $500 million into scientific research, advancing arthritis treatments while pursuing a cure. Progress is being made every day, thanks to the contributions of people like you. Learn more about our research initiatives at arthritis.org/science.

 

Cristina Schaefer:

Some insurance companies and pharmacy benefit managers, like Kaiser Permanente and CVS Caremark, as you mentioned, Dr. Worthing, are requiring people to switch from Humira to one of its biosimilars. Do you think others in the industry will follow suit? Will eventually all patients be required to switch?

 

Dr. Angus Worthing:

My understanding of what happened with CVS Caremark is that the pharmacy benefit manager, CVS Caremark, was able to decide that the formulary that they were responsible for would move from covering Humira to covering a biosimilar, namely Hyrimoz, in most patients. But there was something special about their arrangement.

 

They're affiliated with the pharmacy that they could steer people to, CVS Caremark Specialty Pharmacy, and they also entered into an arrangement where they are a co-owner of the medication, or have rights to market the medication, Hyrimoz, in the United States through a new kind of entity. So, they're both the formulary writer and the owner of the pharmacy and the owner of the medication essentially. So, there's this vertical integration that makes it worthwhile for them to move people to Hyrimoz.

I'm not an industry expert, but I'm guessing that there'll be multiple ways of slicing that apple, and probably pharmacy benefit managers writing formularies will realize there's a cost savings, and they'll participate in the savings some other way, hopefully sharing it with patients. And I think we'll see some people staying on their reference product. I think we'll see a lot of people moving to biosimilars for various reasons, like I said.

 

And then, looking a little more distant into the future, I think people need to be ready to move among biosimilars if they haven't already. The infliximab experience is one that moved people from one drug, Remicade, to another of many biosimilars, and people are moving among those biosimilars now. And they're generally, in my experience, having a good, positive outcome. I think we're going to see that with all of the adalimumabs, but we'll see how it goes.

 

Cristina Schaefer:

Rick, are you seeing, as of right now, any cost savings from switching to a biosimilar?

 

Rick Phillips:

No. I use Medicare, so, to begin with, there really wasn't any cost savings, and I didn't expect that there would be. I don't know that people who are in standard plans are finding a lot of cost savings, mainly because pharmacy discount cards have not stopped functioning for name brands.

 

We have to be realistic. When a person can have a medication with the pharmacy discount card that costs $5 or $10 or whatever, they're not going to see a cost savings for themselves. But once those pharmacy benefit cards, if the pharmacy stops using them, or something happens, like happens to people with Medicare, where they come to the point where they can't use them, then what we have is such an intense price markup that people really have a tendency to stop using their medications. And that's a shame.

 

Cristina Schaefer:

Dr. Worthing, are your patients seeing the same thing? No real cost change as of this point?

 

Dr. Angus Worthing:

Rick is exactly right that, if patients pay an out-of-pocket cost based on a copay program, or if they have, hopefully, a minimal out-of-pocket cost because they have secondary insurance that they're using to pay the balance that Medicare doesn't pay, then they probably won't participate in any of that savings. But there is one place in medications that are self-administered, like adalimumabs that we're talking about, in the Medicare Part D system, like Rick said, where people are not allowed to use copay assistance cards, and in which they have an out-of-pocket cost that's linked with the price, those people will be expected to pay less if they're on a less expensive drug.

 

But the reality is that these are all expensive drugs, so some patients are going to see a break in the price. But that's not going to be the main reason why people take them. The reason will be that they're moving to, or given this incentive, because it's covered. Or the really overall beneficial effect of the system that impressed me with Rick, that people feel like it's time to take a less expensive drug for the benefit of everybody.

 

Cristina Schaefer:

Rick, what downsides are you experiencing, if any, from switching to a biosimilar?

 

Rick Phillips:

Well, the biggest downside is that my wife is very doubtful that the biosimilar works the same. And I just have to keep saying: It does work the same. This has been a fine switch, and I feel really great about it. I don't have any particular downsides.

 

Cristina Schaefer:

It's funny that you mention that, but it's true that, you know, when a patient switches medication, oftentimes it really can affect the whole family. So, it's important to take into consideration your wife's experiences, and you can send her this podcast episode so she can hear more about it. (laughter) Dr. Worthing, any other experiences, negative downsides, complaints that you're hearing from your patients?

 

Dr. Angus Worthing:

Yeah, I think there's two. One is: “Is this drug going be covered at the same amount?” “Does this company fund a copay assistance program, like the one I'm currently on, or that I've heard about with other drugs?” So far, the prior authorization process for Humira biosimilars have been smooth, from my perspective.

 

The other concern is maybe what Rick's wife is getting at, and I understand this from a lot of my patients who are just concerned about any possible disruption in getting their medication or their medication working right. And these are people who generally either had a delay in their diagnosis for weeks or months or years, or they had kind of a time of it, getting onto the right drug or the right combination of drugs that was working for them. And so, after all of that, in hindsight, they don't want to mess with it. I get that. I totally understand that sensibility. But for the people so far that I've been taking care of since infliximab biosimilars entered the market in 2016, things have been going as smoothly as predicted.

 

Rick Phillips:

I think that it really is a lot of where you are in the treatment pattern. And I think that if you are getting along well with your current biosimilar, or biologic, and you're switched to a biosimilar, and you have a positive attitude, I think that, by and large, things are going to go pretty well. I think, though, that I've heard people say, again, “I was trying to preserve the amount of time I could stay on my current biologic because it seemed to be failing.” A biosimilar, I don't think it’s going to help that at all.

 

I've been on my biologic now for 14 years, and that's really routine. And we know how it works. We know what to expect. And 14 years is a long time. I didn't want to throw the dice and have a failure. But I really am convinced that we should not be having failures because of the change.

 

Cristina Schaefer:

So, Rick, you were in a situation to where you wanted to change to a biosimilar. For many patients, they might be forced to change to a biosimilar. Dr. Worthing, can you tell us a little bit about how those conversations take place? How are they typically notified, and also, what questions should they be asking either their doctor or their pharmacist?

 

Dr. Angus Worthing:

Most people who hear about a change in formulary coverage for their biologic are hearing from an email or a letter from their insurance carrier or their pharmacy benefit manager. But hopefully there's been a context of knowing what a biosimilar is already for people who have been taking this medication and seeing a rheumatologist for perhaps several years, knowing that this day was coming, where biosimilars would be available, and maybe that moves among formularies would be happening.

 

I and a lot of my colleagues have been talking to patients, just a really brief tidbit at the end of a visit, for example, to just let you know there's a biosimilar for your drug that's been FDA-approved, or there's multiple biosimilars, and I would frame that fact positively. As Rick has been saying throughout our recording tonight that this medication is FDA-approved. Your experience is expected to be the same safety and same efficacy as the reference drug. And so, if and when that day comes where you're moving to a biosimilar, I expect it to work fine.

 

Hopefully people will have had some sort of basically positive framing about the rigorous FDA approval process when they hear that biosimilars are coming and that they are supposed to move to a biosimilar. In our clinic, we sent out emails to everybody taking Humira earlier this year, in 2024, when we found out that CVS Caremark was moving many people to a biosimilar, just so that people would know that that was coming for most people.

 

Some people are interested in them, and when the conversation came up with Remicade that there was a biosimilar available, and that people weren't being forced to move to a biosimilar, some people chose to when I had let them know that this might be less expensive for them. It might be less expensive for their company, or employer, or for the system at large. So, I think it's an option for people, and sometimes they choose it. And then it's also something that they are forced to do in order to stay on their biologic. And in both situations, it's working out well so far.

 

PROMO:

Biologics and biosimilars. What’s the difference? And what does it mean for you? It can be confusing. That’s why the Arthritis Foundation provides guidance on what to consider in your own situation. Get the facts from the arthritis community’s most-trusted source of information. Visit arthritis.org/biosimilars.

 

Cristina Schaefer:

Dr. Worthing, do you know when biosimilars to other reference products might come on the market?

 

Dr. Angus Worthing:

We're expecting a biosimilar to ustekinumab, which is Stelara, in probably the next several months, early 2025. That's a drug for psoriasis and psoriatic arthritis, as well as inflammatory bowel disease. And then etanercept, or Enbrel, the first self-injectable biologic in the U.S., is expected to be available in 2029. The delay is not based on the FDA approval process at all. It's based on court cases and how the different manufacturers agree, or agree to disagree, about when it's going to come out.

 

Cristina Schaefer:

We like to go on social media and ask people to share their experiences with whatever the podcast topic is. And, of course, today we pulled some information, some feedback, from Instagram, asking people to share their experiences with biosimilars. And we got a lot of responses. Many of them were people who were being made to switch and looking for other people's experiences. So, I'd like to go through a few of these comments, and Dr. Worthing, if you or Rick have anything you'd like to add or any experience you'd like to share based on the comments I read, feel free to jump in.

 

The first one was, “I have never used Humira, but Hyrimoz is doing wonders for me. I believe the injection is a bit more painful, but personally, I was on IV Simponi before, and that was a whole other level of uncomfortable.” Any thoughts there, Rick or Dr. Worthing?

 

Rick Phillips:

I think that that's probably going to be a typical response going forward. Not that one medication was better or worse than the other, but that something might not have been exactly the way the person liked, or the medication was not effective for them. So, they were looking for a switch, and they made a switch to a biosimilar, and it worked out well. And I think that's going to be a typical reaction going forward.

 

Cristina Schaefer:

Another comment here: “I failed almost everything — Enbrel, Cimzia, Orencia and Inflectra — over the last 20 years, and now have been on Abrilada for a year. And it is working great.” So, another positive experience. Anything you want to input there, Dr. Worthing?

 

Dr. Angus Worthing:

Well, first of all, I think it's awesome that people are sharing their experiences with biosimilars on social media. This is one of the great things about social media, is people can share their experience in real time, quickly. The most surprising thing about that, I'll say, is that somebody was failed by so many biologics in their disease. That's not typical. Usually, the first or second one works pretty well. But thrilled that the biosimilar worked for that person, and I hope it works for a long time.

 

Cristina Schaefer:

Another comment that came in: "My rheumatologist told me to stay far away from them. I've been on Humira since 2018, and since my second injection, my oral ulcers went away. Humira has seriously changed my life." Dr. Worthing, I know you and other rheumatologists, you mentioned that you're trying to spread awareness and educate patients on the benefits of biosimilars and how effective they are or can be. What are your thoughts on that, on a rheumatologist potentially, or in this case, frankly telling someone to stay far away from them?

 

Dr. Angus Worthing:

Well, my first reaction is: When did they say that? Actually, to tell you the truth, as I mentioned, I was one of the volunteers at the forefront of the biosimilars history with rheumatology several years ago, when people hadn't yet used them. And I think it's like riding a bike. You know, once you can do it, it seems easy, and you just keep doing it. Once people get experience with it, I think their comfort level goes up. So, I wonder if that rheumatologist was talking in, like, the late teens, you know, 2016, '17, '18, when most of us were just starting to prescribe our first biosimilar. It could also be that that person had a very difficult problem.

 

She or he was talking about oral ulcers, which can make it really difficult, obviously, to eat and drink. And it's possibly a disease state that's not on the list of FDA approval. I don't know what that person's getting it for. So, if a biosimilar hasn't been FDA-approved for that disease state that that person has, it's a very reasonable thing not to use one. So, a couple of comments, but overall, without talking about any individual person, as we've been saying, biosimilars have been working really well, even when moving from the reference product to the biosimilar.

 

Cristina Schaefer:

We did have one negative experience that I wanted to share. This one says, "I was forced from Remicade to Avsola, and they also dropped my dose. It didn't work, and then Blue Cross Blue Shield refused to let me go up higher in my dosage, get it more frequently or go back to Remicade. This set off a yearlong flare. Finally got relief after trying other drugs and ended up with Enbrel. So incredibly frustrating that insurance got to dictate my medication and dosing without listening to my doctor or myself." Any thoughts there, Dr. Worthing or Rick?

 

Dr. Angus Worthing:

No argument here. It sounds like a terrible wasted year that insurance could have avoided if they hadn't forced that person around and to change the doses and not let them go back to the reference or the right dose. So, I think that is an experience partly about biosimilars, but mostly about finding the right dose of the right drug for the person, and insurance companies or PBMs just messing it up.

 

Rick Phillips:

Yeah, I would agree. I don't know that that's really a statement about biosimilars as much as it is a statement about prescribing. And most of our organizations have been pretty emphatic about attempting to leave the final choice with the doctor as much as possible. I don't know the situation, but it might be counterproductive for a person who's doing well on a particular biologic at a particular dose to reduce that dose and switch at the same time. In that case, you have two things that are going on at the very same time, and it's tough to separate what the real issue might be.

 

Cristina Schaefer:

One more comment here from Instagram. "Insurance forced to switch from Humira to Yusimry. Only difference is the needle hurts. Humira needle size was perfect, with no pain. Yusimry hurts so much." Any comments there?

 

Dr. Angus Worthing:

I'm sorry that happened to that person. I'm not sure if that was sort of an idiosyncratic thing or a difference between the system of delivery. So, people do need to be aware, or should be aware, when they're moving to a biosimilar self-injected product, what the products are. Is it citrate-free? Is it going to still be one shot or two to get the same dose? Is it available as a syringe, if some people do like the control of having a syringe, or an autoinjector. So, there could be different products. They're going to look different, they're going to be different colors, et cetera. That person raises a really important point. But hopefully, it's working really well for that person.

 

Rick Phillips:

In that case, I would suggest that they really talk to their doctor. Chances are pretty good that, if there's not a different, approved biosimilar in their plan, there soon will be. There are lots of companies who are making biosimilars right now, and I think that, in that case, I believe that they might be able to find one that will work better for them.

 

Just one other thing about that before we go too far. Sometimes, people have the misconception that biosimilars are made by three guys in a garage out back, and that's just not true. Biosimilar companies are the very companies that are making the reference products. So, they're made by Pfizer and Amgen and AbbVie. These are the companies that are making reference products, and they have a long track record of producing high-quality medications. Sometimes, our first reaction is that, "Oh no, this is a cheap knockoff." And it's truly not.

 

PROMO:

Whenever you need help, the Arthritis Foundation’s Helpline is here for you. Whether it’s about insurance coverage, a provider you need help from or something else, get in touch with us by phone, toll-free, at 800-283-7800. Or send us a message at arthritis.org/helpline.

 

Cristina Schaefer:

I'd like to hear from each of you if you have anything else. I feel like we've had such a meaningful conversation today. But anything else that you have to share that we haven't touched on? We could start with you on this one, Rick.

 

Rick Phillips:

My takeaways are: Biosimilars are coming. If they haven't already come to your doorstep, they will, in all likelihood. I think it's best to give it a fair shot when they do arrive. And I think it's incumbent upon us, where we can, to find lower cost of delivery of these incredibly expensive products. You know, the biologic I was using cost $50,000 three times a year, and I feel such a responsibility to attempt to reduce that cost. And I think that when most people think about it, they will also understand how important it is, just so we can maintain access across our community.

 

Dr. Angus Worthing:

I would love for people to also know where to go for more information, besides their rheumatologist. Two important pieces of information are: the FDA website. If they just put in their search engine, "FDA and biosimilars," there's really good patient-facing, also prescriber-facing, and multiple different angles of information there. Also, the company that makes any one biosimilar will have a website, obviously, with important information about which products are available. Is it the same concentration that you've been getting before? Is it citrate-free? Is it a pen? Is it a syringe?

 

And another place that's a little more technical to find that is at a place called The Purple Book. It's a strange name, but the FDA has put out a Purple Book, which, if you put in the reference product, for example, Humira, in that search engine, you get all the seven biosimilars and the four what are called interchangeable drugs, all with prescribing information and some technical information.

 

Cristina Schaefer:

Dr. Worthing, you mentioned interchangeability. Can you explain to us what that is, and is that something that patients should be concerned about?

 

Dr. Angus Worthing:

Sure, Cristina. There's two kinds of biosimilar labels in the United States from the FDA. One is biosimilars that we've been talking about. The other is a designation or a label of interchangeability. And what it is, is simply a pharmacy designation that allows a pharmacist to substitute that biosimilar that's interchangeable for the reference product. If, for example, a patient is prescribed a reference product, and there's an interchangeable biosimilar at the pharmacy, the pharmacist can substitute it, much like a generic for a brand name pill.

 

What has happened before that, to get to that designation, is simply that the manufacturer of the biosimilar has done an extensive clinical trial in which they compared two groups: one group that's on the reference product and another group that started on the reference product and then switched back and forth three times to the biosimilar. And then, at the end of the trial, they compared both groups, and they checked for whether the people became immune to the drug more quickly or had other side effects.

 

And the end result of that, if they got that designation of interchangeable, is that they were equivalent, so they were expected to be the same, so that people, and prescribing doctors and patients, can be confident, if they're getting a drug substitute at the pharmacy, that it’s going to be the same experience when they alternate.

 

Rick Phillips:

I really don't know exactly how I feel about that in particular. I do think that patients should at the very least be notified and should have some input into the change. The FDA has been able to find, over the course of time, that these bio-equivalents are safe and effective.

 

Cristina Schaefer:

And Dr. Worthing, what are some takeaways that you have for us?

 

My takeaways here are, just like Rick said: Biosimilars are here, and they're coming. People's experience are expected to be the same with biosimilars as they are with the reference biologic, the same safety, the same efficacy, and so it should be the same. And then, I'm really looking forward to a day in which we'll find out exactly how much a biosimilar is worth and a biologic drug is worth. You know, for the first 25 years, the price of biologics tripled, despite the entrance of multiple, multiple competitor drugs, and that's because the middleman, the pharmacy benefit manager in the United States, was able to play them off of each other, like an auction, to raise the price. Just like you, when you're selling your house, and you have multiple buyers. The price went up.

 

Now, with biosimilars for the first time, the price, for example, of Remicade is more than 50% off. So hopefully we'll see driving down of the price — employers, governments, which includes states and the federal government — all hopefully paying a lot less. And a lot more people able to access these medications without the hurdles, without the authorizations, and step therapies, and copay cards, and all that. So, my vision's very positive for this, and I'm thrilled to be able to be part of this conversation. And I'm really thankful for everybody who listened in today.

 

Cristina Schaefer:

I think my biggest takeaway was, as somebody who is not on a biosimilar and hasn't — there is no biosimilar for the medication that I'm on at this time — but it really highlighted the importance of staying educated about my disease and potential treatments. So, if one day I am required to make a change, it won't be so scary. So, I wanted to thank you both for joining me in this conversation. I feel like we've been able to shed some great light on this important topic.

 

Dr. Angus Worthing:

Thanks, Cristina, and thanks to the Arthritis Foundation. And thanks, Rick, for sharing your experience. I really appreciate it.

 

Rick Phillips:

Well, thanks, Cristina, and it's always a pleasure to talk about this topic. And it's always a pleasure to speak with somebody from the Arthritis Foundation, where we really are doing the most forward patient work of any organization in the country for people with rheumatic diseases.

 

Cristina Schaefer:

Absolutely. Thank you both so much.

 

PODCAST CLOSE:

This episode was brought to you in part by Boehringer Ingelheim

 

The Live Yes!With Arthritispodcast is independently produced by the ArthritisFoundation. Gifts from people like you make our podcast and other life-changing resources possible. You can donate at arthritis.org/donate. This podcast aims to help people living with arthritis and chronic pain live their best life. People like you. For a transcript and show notes, go to arthritis.org/podcast. Subscribe and rate us wherever you get your podcasts. And stay in touch!

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