Transcription Episode 77

Biosimilars - What patients should know

Tiffany: Welcome to AiArthritis Voices 360. This is the official talk show for the International Foundation for Autoimmune and Autoinflammatory Arthritis. Or we just say AiArthritis for short. My name is Tiffany Westrich- Robertson. I am the CEO of the organization and also a person living with AiArthritis diseases myself.

And that would be non-radiographic axial spondyloarthritis. Yes, that is a full mouthful there. And I am really excited to be here today, representing the patient voice alongside three wonderful professionals in the space. We will be talking about biosimilars. So this is a hot topic for people living with AiArthritis diseases, and I am very honored.

We are very lucky to have these three here to speak with us today. So I'm going to turn it over first to Michael Reilly to say hello.

Michael Reilly: Well, thank you, Tiffany, for having us here today. I am the executive director of the Alliance for Safe Biologic Medicines (ASBM). That is a position I have held since a ASBM was created back in December of 2010.

We have been around from the very beginning of biosimilars. Once the affordable care act gave the authority of the FDA to set up the pathway and move forward with biosimilars. ASBM has been there both domestically and also we are very involved on international level. Prior to my work at ASBM, I was mostly in the department of health and human services in the office of the secretary. Serving as the associate deputy secretary working on FDA and CMS regulatory issues. And it's great to be here!

Tiffany: All right. Well, it's absolutely great to have you and AiArthritis is a proud member of ASBM, have been for many years and just a real big fan of everything that the coalition is doing.

And we also have with us, Dr. Ralph McKibbin. Hi there. 

Dr. Ralph McKibbin: Hi, thanks for having me. I'm always happy to help and happy to have input here. I'm also affiliated with the Alliance for Safe Biologic Medicines, working as a chair. And my background is more than 30 years as a practicing gastroenterologist, and I'm still an active practice. But I have an advocacy background working with the Pennsylvania Society of Gastroenterology. I'm past president, the Digestive Disease National Coalition (DDNC), which is an umbrella organization. It is a group of pharma, physician, and patient groups working together to advocate and through the American college of gastroenterology, working in practice management, working on insurance contracting and things like that. So I have a broad background and that's kind of brings me here today to talk about biosimilars and biologics, which are a hot topic.

Tiffany: Yes, they are maybe one of the hottest topics for sure, in the patient community. And last, but certainly not least we have Andrew Spiegel.

Andrew Spiegel: So I’m Andrew Spiegel. I hold a number of positions in this patient advocacy community. I am the chair of the World Patients Alliance, which is an umbrella organization of nearly 400 patient groups from 113 countries representing all diseases. And I've certainly gotten a great deal of international exposure in holding that position.

I'm also CEO of the Global Colon Cancer Association. And similarly we are an umbrella organization to all colorectal cancer and bowel cancer organizations around the world. And some of the other positions I've held are where I met these gentlemen at the Digestive Disease National Coalition, I'm a past chair.

So I worked with Dr. McKibbin on policy issues for the United States for many years at the DDNC. And of course, Michael. I've worked with Michael since he created the Alliance for Safe Biologic Medicines more than a decade ago. And I've been with him since the beginning. And we have literally traveled the world advocating for patient centered policies.

We have met with regulators literally in every major country continent around the world. Michael is being very humble with how much work he in the organization has really done to make sure that the patients are at the forefront of all biosimilar policies that have been enacted around the globe over the last decade.

So really thankful that you've invited us here, Tiffany, to talk about biosimilars today. 

Tiffany: Yeah. And again, thank you all so much for being here. I wanted to sort of just start out as a person living with these diseases myself and speaking on behalf of the community, you know, there is, there are a lot of questions around biosimilars and they start with just what is a biosimilar, which we're going to jump right in, in the, in a moment, but even more so is I think why we wanted to bring this to the table or to the forefront right now is we are at the point where patients are moving to biosimilars and there's a lot of good that comes with this in healthcare costs and saving money. And we're gonna talk about the international aspect of this as well. Our organization being international and I have attended a couple amazing webinars hosted by, by the group. Some of the groups represented here today and did a wonderful. On showing how, where we are here, where I live in the United States, but also how this is relevant internationally. And when I talk to other patients, the biggest thing that comes up is just fear. And I think it's not only fear. I think the fear is derived a lot from just simple, lack of knowledge - you know, “Wait a minute? This isn’t the same biologic that I’m using? What is this going to do to the quality of my life?”  And I can say the biologic I'm on. It took a while for it to start working. I had one that worked amazing for about six or seven years. And when it stopped, it took about a year. And now that I have a continuity of care, now that I am in a place, I can sit at the table and speak with all of you and have high energy and probably work a little bit more the rest of the day. I couldn't do that if I didn't have a biologic or the access to treatment that works best for me. And that's why this is so important because there will be several many millions of patients around the world who might be facing a time where they are being told it's time to switch to biosimilar. 

So let's come together, have a conversation, learn a little bit about what they are, what are some of the issues surrounding biosimilars? What do doctors and patients, what do we, both of us, think about this? So we're gonna get into that as well, and then we're gonna provide resources.

So let's start by talking about - what are biosimilars? And I think Dr. McKibbin, you are gonna start us off. 

Dr. Ralph McKibbin: Well, I'm happy to do that. And one of the ways I like to explain complex things is try to use simple terms. Atoms are, you know, the building blocks of molecules and, and whatnot. I think, just to talk about what is the size and many of these are antibodies as an example.

So an antibody is 50,000 atoms in size. So think of a gigantic transformer robot made out of Legos, one Lego versus 50,000, and these things are made by living yeast molecules or yeast organisms, et cetera. They create these antibodies through their own genetics and they're directed towards something, but because they're made by living organisms, this is a definite possibility that they will not be exactly the same.

They are directed at the same offending antibody or problem in the person that's causing the disease, but they are not exactly identical. So when you have this, you have something that's very similar. You're gonna have a hard time telling it apart. It's tested to show that it does the same thing, that there's no additional fears, side effects, reactions, et cetera.

And they go through a lot of complex testing, but they can't label it identical because that would mean it's exactly the same thing. And so it isn't, it's highly similar and that's a charged word. Michael and Andy had some discussion on it earlier. Similar is one of those things that scares you.

It's like, well, that's close, but it's not the real thing. But a biologic is a big molecule that has a function, it's made by a living organism. And the similar is made the same way, but it's a different company's process. So it can only be called highly similar. 

Tiffany: Okay. And that in itself can generate some level of concern for people like me living with these diseases. But I think one of the, one of the points, or one of the words that came out of this as, you know, is safety and research, and we're gonna go into that a little bit, because I think it's important for patients to be aware of the research that has happened and where biosimilars are in different areas of the world, because that's also going to impact how they feel 

Michael Reilly: Tiffany, could I just jump into, yeah, go ahead to say that as a former regulator, I think the most important thing when Dr. McKibbin talks about the word fear, fear is from the unknown fear is from, you know, basically there is an absence of information and then people go to fill that information.

And I think this is something that Andy and I have really focused on - me as a former regulator, him as a patient. Advocating over the years from the beginning was to make sure that you are giving accurate information. So that is ultimately the issue. We often see this where there are conversations about saying something's “different” , implying that it's worse.  Saying something's different is implying that it's inferior, saying something's different, and literally we've worked on this issue, whether it comes to naming, naming something different. 

And ultimately what really matters is that the regulatory standards are kept high (and they are) and if you're approved as a biosimilar in the US, and we certainly have focused on regulatory standards globally, that we don't believe that there is any way that you should diminish those standards, keep those standards high.

And then you can go in and basically fill in the educational void and say, the first thing you need to know is that from a safety and efficacy standpoint, Basically, they are basically equivalent and we'll get into other issues that are related to this like interchangeability. But at the end of the day, there is a distinction between saying that it's very, very close, safety and efficacy is similar, but ultimately physicians still wanna be in charge of decisions.

And that's a big topic that, you know, I know we're gonna get into, but it's really important to understand that just because a physician says they want to be making a decision on behalf of a patient doesn't mean they don't have confidence in the biosimilar itself and it's their job in part to educate the patient about the quality, to say you have nothing to be concerned about.

Tiffany: Yeah, absolutely. And just to piggyback on what you just said - as far as making sure that the words are clear and we're using the right terminology. That is, that words don’t evoke any more fear, something to also consider as a person living with the diseases. 

We are often in online groups and these are international groups. I mean, you're talking to people in Canada, you're talking to people in Australia and we're all dealing with this. But these perspectives, that may or may not come from a position of having the background knowledge, and you start seeing these conversations - peer to peer conversations -  they're listening to what the other patients are saying.

And I think that that's a place that organizations like AiArthritis can really get in there and start to take the opportunity to educate. As we're in there as well and relying to people the right information. And also, as you mentioned, it matters about the regulatory standards. Could you just elaborate a little bit for those who may not be familiar what ‘regulatory’ means?

Michael Reilly: Sure. I mean, there has been conversations mostly going on around the World Health Organization (W H O) and others about the need that basically in less developed countries, there is a concern that the regulatory standards are too high. Andy has been with me where we presented and I presented in, in Dublin and in Berlin where we had conversations in panel conversations with EMA regulators.

Literally after I presented in my final bullet was that there should be no easy point of entry, meaning that the standard should be the same, no matter where you live, you should never do standards of safety and efficacy in a country because they might have resource issues because who is that to say that, you know, because  you happen to live in a country with less, less developed country. And the EMA in particular has argued at times that there's actually a moral calling for us to recognize that you need to reduce those standards of those countries. And we just say, we disagree. We think the standards shouldn't be diminished. And if you do that, you do undermine Dr. McKibbin, certainly as a physician. Can tell you and we know as you get into things like interchangeability, where more data is required, that that gives you an even higher degree of confidence. And then you get into issues like substitution.

So just from a regulatory perspective, we think that one of the most important things to do is let's build on the success we have now. And don't kind of revisit well, as I say to people, what would be the new reduced level of standard for regulatory approval? Where do you go from where you are, where you're building all this confidence over a period of time, to all of a sudden, you say, well, we think it's too high in certain countries.

They can't meet that standard. So let's let them come a little below that. And then what is that new floor? That's where we're concerned. 

Tiffany: Okay. And just for, for reference EMA is European Medicines Agency, and we're talking about as these medicines are being researched and shown to be working - to be effective, to be safe. And the standards of the research in this case, European Medicines Agency. In the United States we’re talking about the Food and Drug Administration. So just wanted to clarify.

Michael Reilly: That. And also just one more thing. It's also important to note that when this conversation is going on at say the W H O or wherever it may be going on, it's really not even talking about the standards.There's no conversation about reducing the standards within the European. You know, at the European countries that are under the EMA, they're talking about reducing the standards in other countries that are less developed. And what I say is, you know, if you're not willing, if you don't think you wanna reduce them in your own country, why are you looking at reducing those standards in less developed countries?

No, 

Tiffany: Absolutely. I'm going to turn it back to sort of the original questions that I was saying as a person, living with diseases, as far as what patients are really concerned about. And I know Andy, you had some things to add to that as well. 

Andrew Spiegel: Yeah. So a lot of the work I've done over the last decade has been from the perspective of a patient advocate.

I've been in the patient advocate community for more than two decades. And so I feel like I have some pulse on on how patients feel about these medicines, especially with all the survey data that we've conducted and reviewed and, and all of the work that we've done all around the world. And I think that what you would hear if you surveyed most patients, is that they are excited about the introduction of biosimilars into the marketplace because biosimilars create more treatment options for patients and with more treatment options comes more decisions that the patient and the physician can make together about which medicine is right for them.

And it also serves as a reduction of overall healthcare expenses. And so one of the things that we've seen in Europe, where the countries track the savings from introducing biosimilars into a marketplace and where they track the reinvestments of those savings, more patient gained access to the treatment because of the savings of the introduction of biosimilar.

So that's the promise of biosimilars because as a patient you know, why would I wanna take something that's relatively new versus the original product that's been out for maybe 10 or 15 or 20 years? There's gotta be a little bit of skin in the game for the patient to take a relatively new medicine that has been studied and has been approved by regulators, but it just doesn't have the volumes and volumes of research that's been done over the years.

And so, you know, Patients have to feel that these biosimilars are safe and that they're effective and that they're good for them. And that they're not a bad thing. And so there, there is an there's an educational piece that has to go along with the introduction of biosimilars there's transparency that has to go along so that patients don't feel the governments are pushing these things and telling them what to take and that Or, or worse yet not telling 'em what they're taking.

And that has always been a big issue in the introduction of biosimilars is that sometimes patient aren't even being told, are being switched from something that's working for them or that they're being put on a biosimilar as as a start of treatment without being told that they're being put on it.

And then later a patient finds out and then there's this whole trust issue with the medical system and trust issue with the physician. And it's just easier if everybody's open and upfront at the beginning - that we are transparent about what a patient is getting and why they're getting it. And that, I believe, can lead to greater uptake of biosimilars.

And that's what we want. We want biosimilars to succeed. We want this to be a success story in order for that to happen, then we've got to continue to not only have transparency as I've said, but as Michael has said, we have to maintain high standards. Because the last thing we want to do is switch a patient to a biosimilar that has been approved based on insufficient data in some up and coming country or a middle income country or lower income country that, you know, may not have the resources of an FDA. Or as you say, in, or in European medicines agency behind them, but if you start lowering those standards, not only is it insulting to the people of those communities that they shouldn't, they should have an inferior set of standards for approval in their countries. Mm-hmm , but it's unsafe not only unsafe for them, but it's unsafe for the whole biosimilars market, because if a problem happens somewhere in the world, The media's not gonna say, oh, well, you know, it's a little different in Columbia because they lower this standard.

It's just gonna hear a hundred patients died from taking a biosimilar and that's going to destroy all the hard work that's happened over the last 10 years around the world to to sort of get uptake better, to make biosimilars more, a part of the standard therapy. So, those are some of the hot issues that we focus on as patient advocates.

And I'll close that out with one more hot issue and that is the control over a patient. There has been a movement that I have personally witnessed over the years in this space where regulators have essentially tried to remove physicians from the equation. They have essentially said, if you are a person suffering from a certain disease, you're going to be given a medicine. We're going to decide that the medicine best for you is this. And they end up switching an entire class of people, entire group of people to a medicine that they were not taking previously. They were taking something else. And the government made the decision to switch them for the sole reason of saving money.

And that's what we call non-medical switching. It's being switched from your medicine that's working for you, not for a medical reason, but to save the payer, whether it's a private payer, a private insurance company, or whether it's a government you're, you're saving to pay your money. And we have been very, very clear that if that's going to happen physicians have to be part of that equation.

If you Tiffany, if you're on a biologic and you are, and somebody's going to switch that biologic, that's working for you to something else, you want your physician involved in that decision making right? 

Tiffany:100%. 

Andrew Spiegel: Believe it or not, that's been a major challenge that we've worked on around the world to keep physicians involved and engaged and in charge of our healthcare.

And with that, I'll turn it back over to you. But that's sort of what the patient perspective on with a couple of these hot issues has been.

Michael Reilly: Can I just make one point of clarification when Andy said, Andy, when you said regulators, I think we have to be very careful here. By not using the word regulator, because that has to do with the FDA and the EMA and health Canada.

We're talking about policy makers in health ministers and governmental entities like in Australia, but regulators are different. They usually do not have the decision around switching; it's usually made at the provincial or the state level. Right. And it's a really important distinct. I want to clarify 

Dr. Ralph McKibbin: something Andy said, because this actually involves two different issues.

One is as a simple example, if you were on an allergy medicine or an antibiotic, there may be a preferred agent. And in the past there's preferred biologic agents, preferred originals. And you might be best off on one, but your insurance carrier may decide that the whole class of people have to move to the other.

So that's one type of medical switching and then the other switching from your originator biologic to a biosimilar. So they're not the same thing. You could be switched in two ways. Switch to an entirely different medicine, but also then a similar one. And to echo what Andy was saying that there's a lot of decision making here.

If you look at the surveys from the ASBM over the years, there's a growing concern. If you look at the 2013 and versus 2019 EU. The physicians are more conservative in saying that it's critical and important that the physician and patient have control over the decision making. So this is not something that goes away with time or hasn't so far, we're actually seeing that people are actually becoming more concerned and they want to see the data and transparency that shows that these are the correct decisions to make.



It's a loaded playing field. When we use words like similar, to be fair, that word is a loaded word. It sounds like you're getting something, a knockoff maybe, or, or something. We grew up in an era of branding, whether it's automobiles or food or clothing. And we as a world, society of consumers tend to look at the brand name.

And then we look at the others as similar and are they as good or different? And so we have a branding thing that's in us and it's a little difficult to believe wholly that we should switch over. And so the language is loaded and there's a lot of advertising for the originator projects products, because I believe that they're doing it because it works.

And so we have to look at all the players and everything that's there. And when patients come to me, I have to say to them, yes, this is an effective medicine. The FDA uses the word, not the FDA, but the regulators use the word similar and it has these effects. And so as you see in the surveys in the most recent US survey, physicians are over 90% confident in prescribing these biosimilars to a new patient.  Where we get concerned is switching stable patients, who've been on a medicine for many years.

Well, we've all seen stories in the news about a medicine that's been out for 10 years and there's a surprise twist to it. So we worry about these stable people. They got their lives back, and now we put them at risk for a problem. So. We want to be careful with that. And the other thing is truthfully, when you look at the studies, they tend to use single disease state patients.

You only have Crohn's, you only have arthritis, you only have this, but there are many people that have multiple conditions. Eight to 10% of people with Crohn's disease will also have rheumatoid arthritis or other conditions. So now you're treating multiple conditions. It's a mosaic and there aren't good data on that.

So we tend to be conservative. Let the other people go first. We'll see how it goes. We'll get some reports and then we'll switch you. But we don't want you switched right out of the gun because the insurance company or the government can save a little money. It's not in your best interest. 

Michael Reilly: Yes. Just wanna add one thing, Tiffany.

Yes, go ahead. And that is when Dr. McKibbon referenced the 2013 -2019 EU survey and talked about, and that is something that I presented actually at, at ESMO in Barcelona in 2019. That survey, the two things. He mentioned, the fact that from 2013 to 2019 physicians became basically more committed to being involved in the decision making and less accepting of non physicians, making those decisions.

But at the same time the physician, as you can imagine, the physician confidence grew substantially in that same period of time. So it just could go to show you that, and this is something we really tried to point out just because physicians say they wanna be involved in the decision making, it doesn't necessarily mean that they don't have confidence in the product. It means that they want to be involved in the decision making. And you began this podcast. By talking about your own experience, being, you know, being on medicine, being affected for six years and then taking a year for you to find something that worked. And that's really the issue that we have heard from health ministers all over Europe that they from I should say some physicians all over Europe, that that's the point that it takes time to get a patient to stable.

And that then is, you know, basically whether it's switching from a biosimilar to a biologic or a biologic to a biosimilar in, in some respects, it doesn't matter. It's switching from what got you, stable to something else. I wanted to and what I would, 

Andrew Spiegel: I'm sorry, what I would add to all of that is that this is not hypothetical.

This is not a hypothetical scenario that we're laying out there. This is happening now. And I don't know if Michael, you want to talk about what's happening in Canada. But patients are being forced by the government to switch off of a medicine. That is, that is keeping them stable. That is happening all across Canada.

Now it, it happened in Australia where metastatic stage four cancer patients were taking off of a medicine with a week's notice of a medicine that was working with them and no availability to get that medicine. The manufacturer was allowed to take it out of the country when a biosimilar was introduced.

So, you know, these challenges to the doctor- physician relationship are real and are growing and are happening right now around the world. So this is not a hypothetical conversation.

Michael Reilly: And I wanna just let Tiffany get back on her schedule as we move forward and then get back to that particular topic though.

If, if it, if it comes up, certainly you know, at the end, you're gonna talk about resources. And as you mentioned in the beginning, we just at ASBM - and you were a part of, you know, two webinars that we just did. One of those webinars was on the non-medical switching, that's going on in Canada. And just, that is certainly a reference and a resource that I would recommend people look to if they're interested in that.

Tiffany: 100%, those resources, we will be sharing those. Absolutely wonderful. And we'll probably do some spinoff conversations of this episode just on those resources, because they are extremely well written, easy to understand from a patient perspective and really gives a lot of not only education, but - and that's really what I wanted to sort of zero in on here is something that Dr. McKibbon alluded to - when is it okay to be substituted when isn't it okay. And more clarification. We've talked a lot about non-medical switching, but the difference of non-medical switching versus other switching. We've talked about interchangeability, but we haven't really dove into that so much yet.

And then there's automatic substitution. So I was hoping somebody could just clarify those three, because I know that they are individual issues and, and, but important for our patient community to understand. 

Michael Reilly: I'll start just by saying that from a policy perspective, what we have seen - and I know Andy's been with me when I've been meeting with health Canada, and there's an argument about interchangeability and what interchangeability means and the recognition of, you know, the fact that interchangeability means one thing in the US and it means another thing and Canada, which is similar to what it means in the EU. And so there has been this little bit of a battle. But let's start with substitution at the end of the day. Particularly in the US, the idea of substitution has to do with specifically switching from one medicine to another.

We've talked about, you know, the non-medical switching in general, but in terms of substitution, we're really talking about physician led substitution or pharmacy level substitution. And I'll get into the interchangeable thing in a moment, but really in the United States, we've laid a tremendous groundwork for automatic substitution, which is widely accepted.

And generally, you know, certainly we know that within the generic framework and understanding that a biosimilar is not a generic.  But when you start talking about interchangeability, you're getting closer to the idea of at least the additional data, so that physicians have additional levels of confidence. So in the United States, ASBM was involved from this from 2013 on, you know, we worked to basically say that once an interchange.

So an interchangeable biosimilar is essentially not a better biosimilar and it's a very important distinction. It's a biosimilar that has additional data. And that additional data may give physicians a higher level of confidence within because they're always looking for data. And we'll certainly let Dr McKibbon talk about that in a second, but that we've seen that globally.

As we talk to people about the concept of interchangeable biosimilars we met with healthcare with health Australia with the TGA and with the department of health in Australia. And they were very intrigued about the idea of interchangeability because they recognized that what the physician community in Australia said is “we want more data.”

We don't think there's enough data for us. And that was in a context of where essentially Australia tried to go to automatic substitution. But allowed the physician to basically say whether or not they would, you know, put, do not substitute. And 98% of physicians put “do not substitute.” And they didn't think that would happen.

They thought physicians wouldn't do that because it was additional step. And so interchangeability is essentially where the FDA approves a biosimilar as an interchangeable. It requires additional studies. It must demonstrate that there'll be no difference in any given patient. It has for the most part, and there are some exceptions around insulins in particular, but you're generally required to provide switching studies that show no difference between switching back and forth. Once it's approved by the FDA as an interchangeable, ASBM and others have worked for, you know, from 2013, almost 10 years, we worked to establish because substitution is determined at the state level, generally through legislation and rule making.

And so right now all 50 states have legislation that basically was passed that allow for automatic substitution to happen once it's approved as an interchangeable. This was all worked out by the way, over the period of time. And in the beginning, there was a lot of resistance to this by the physicians and the pharmacists and lots of entities. Basically, in most states, it is required that within 72 hours you notify the physician of the substitution. So there is the, the pharmacist must notify the physician. So there's from a pharmacovigilance standpoint, there's that give and take. And that was part of what was worked out. But essentially we all generally come to agree that if it's an interchangeable, then we are fine with the pharmacy level.

Automatic substitution. And that's what both ties in the idea of interchangeable, which is that additional data from the FDA and automatic substitution, which is again, an accepted practice. Basically, it's all been worked out in the United States and basically every one of the 50 states recognizes that if you're approved by an automatic, if you're approved as an interchange, That's going to happen and that's really clearing a lot of rush to, to move forward on that issue in terms of the work that was done from 2013, I believe the last state was last year.

It was Oklahoma, I think was last. And it was in 2021. So that kind of wraps that piece up. The switching again, when you start talking about switching, you've got, you know, we already kind of previewed nonmedical switching and you can get into that more. But switching generally has to do when you're going from one product to another.

And I mentioned, you know, it could be from a biologic to a biosimilar or a biosimilar to a biologic. Generally what we at ASBM have always said is that no matter what kind of switching it is, the physician should be involved in the switching decision. And at that I'd like to turn it over to Dr. McKibbon because it's certainly something he's advocated for for many years and is personally involved in.

Dr. Ralph McKibbin: Yeah, it's a complicated issue.

And so let me just say this about interchangeability and switching. It, isn't always about the medicine. Sometimes it's about side effects. It's about factory closings, lack of availability and things like that. We've all seen over the years where a baby formula or other things may be withdrawn from the market because of factory problems.

So that's a reason for one pharmacovigilance and tracking, because if someone's being switched more than once and something happens, you want to know where did that come from? So we really do need to track these medications and you have to have a central record and the patient's record should. Every medicine that they've been on.

So I know that there's some acceleration in the interchangeability. I was looking today over some data for adalimumab, which is an antibody for autoimmune disease. And I think next year there's two interchangeables coming out or slated to come out just for that particular agent. So we're going to see more of that.

The concern is you may get switched, but if your insurance carrier or government keeps negotiating the contract and they keep coming up with a new agent that's cheaper. Could you be on three, four or five different medicines over a course of the same number of years? And is that good? Is it the same?

We don't have data on that. And so as a physician, I tend to be conservative for my patients. I want the data that says there are no increased risks and that's why we want those studies because this is a lifetime process. If you look at, and I shouldn't bring this up, but the COVID monoclonal antibodies.

That's a one time agent biologics are generally long term agents. And so you have long term issues of autoimmune processes, reactions to the medications. One time agents aren't really included in this, even if they're made the same way. So the long term tracking needs to be there. And a lot of the policy maker don't live in a long term world. They're living to the next quarter, the next election, the next appointment or whatever. So we wanna make sure as physicians that we've got the long term view here for patient safety and that's what we want. And that's part of the hesitancy about switching complex long-term patients who took years to become stable and just having them switch to save a little money.

And that doesn't necess in fact, switching in many studies, I did a white paper showing that switch. Even to biosimilars can result in increased cost because of patient's fears switching insurance policies, switching to different physicians to get different treatments. There's increased cost to the system by switching.

It's not just the cost of medication. So it's a complex issue with a lot of stakeholders and players. And while we tend to just talk about the medicine, it's actually the healthcare system and how much time and energy is spent going back and forth. Maybe just to find the security, but we need to track and we have to have that safety information.

So it it's paramount. And that's what keeps getting shown in our surveys. Again, as Michael reiterated, there, we are becoming more conservative about that, but we are confident that these medicines are real and that they work. 

Tiffany: That's really, really important to note. I just can't stress that enough, that they work, they work that they're effective, that they're safe.

And I was going to ask how many interchangeable, where are there currently? I mean, this is something that patients are gonna be asking. 

Michael Reilly: Yeah, there are three approved. In fact, the most recent one was just the first week of August. That was the third interchange was for Lucentis and that's actually our next webinar is going to be on ophthalmics, which is a whole nother area where it's showing, you know, as, as we look at the issue, ophthalmic shows that when we conducted physician survey, We never included ophthalmologists before because they weren't relevant.

And now all of a sudden you have a whole new space, you have a whole new education process. And you know, we kind of view this as the, the, the cutting edge of biosimilars as it expands into other specialties. All of a sudden, you don't, you realize that those groups were left out of the education process and you're starting all over again.

And so ultimately, this does really come down to the degree of education. You can hear, even within this panel conversation, there are so many topics that come up, but I do think the responsibility and it does fall on the regulators, but not exclusively on the regulators. It needs to be done by the patient community.

Obviously industry plays a part as well, which is to give fair, accurate, and you know, information that basically patients can trust and believe. And, and, and again, when we talk about policy and we talk about, you know, just the, kind of the end of it, the other end of it, the non-medical switching side that just raises all kinds of issues that really don't, we view it as it does not really get into.

The quality of the medicine it gets into who should be making decisions basically on behalf of a patient. It doesn't say that, you know, what's going on in Canada, you can judge it from the perspective of where everyone's being switched. And the only people that are making that decision are the government and patients basically accept it.

Does that mean that that's, you know, as we have argued and that's the target of our second webinar was that's not how you build long term confidence within the patient community, the physician community that's short term gain, and it really undermines long term confidence. You know, that's kind of, we think the role of the ESPNs and the, a arthritis and, you know, really, even within the physician community and the government to just do a, a fair job of sharing as much data as you can in as much information 

Tiffany: I'm going to just ask Andy or Dr. McKibbon, if you have anything else that you wanted to add? 

Dr. Ralph McKibbin: No. Other than just to Put a, a word on Michael's last thought there transparency is the term that I often use is the more information you throw out there. Every stakeholder will take that information and evaluate it. And by having meetings such as this one and talking, we can air these things out and find out the significance and share our values and conclusions.

So transparency is the keyword that I, I really use.

Michael Reilly: And I would say one more thing to that to Dr. McKibben's point. And that is when we conducted our webinars. And that's what you are. You are beginning a process and a conversation with this. You've already talked about, you know, moving onto different sections that come out of this conversation.

You can't cover this topic in an hour on a podcast. But at the end of the day, it's saying not only are we willing to provide information, but we're willing to stand there as a resource so that you wanna ask us a particular question. We will give you an answer to that question. You can figure out by looking ASBM's website or Andy's website or your website, the credibility of the organization.

But I think it's really important. And we did this in our webinar. We said, we will answer any question that comes in. We will not say, wow, we didn't get to that. We'll get to it. And we're actually working on a follow up paper to that, to that effect, because a lot of it is just that the patient community doesn't really have the time because they're working on so many issues to know where to get exactly the information they need on every single topic that's out there.

And that's the benefit of, you know, the podcast that you're providing. And 

Andrew Spiegel: the one thing I would add is that there is a resource out there for patient organizations, and that is a a webinar that we put on. We did a two day six hour training webinar at the global colon cancer association in partnership with the Alliance for safe biologic medicines and with the world patients Alliance.

And we, and, you know, T cuz you were on there, you were very active on all six hours, but. We archived all of that information and patient groups can find everything they, they need to know about biosimilars, biologic medicines, the differences, all of the issues that we've talked about today are all addressed by many different panelists.

During those six hours, it's all free and it can all be found at learn, learn biosimilars.org. Learn biosimilars.org is the replay of those six hours of biosimilar training for advocate. 

Tiffany: And something that AR arthritis is going to do, cuz yes, we did attend. I attended the entire six hours. I was, I was, I was interacting and I think I even emailed afterwards to some of you and said that was just absolutely outstanding.

And we, as our organization, something that we tend to do as people living with the diseases ourselves is we like to identify these great resources and have watch. So we will literally watch segments with them. And then we're there to ask questions as well in real time. So that is something to, to look forward to it's we learned so much.

From our community when we do that and it's, you know, it can be kind of fun cuz we can stop. We can pause. We can rant about something that we're mad about, you know, whatever. something that that's of concern. But we really do learn about a lot about each other too, as a community and, and ways that we can help each other through that.

I think as we start to get to the last sort of segment, which was the resources, I just want to, to ask this question. We as a person living with the diseases we are told it's time, you're going to be switched to a biosimilar. What should we do? What is the next step as a person living with these diseases that we, we should take to start.

Dr. Ralph McKibbin: Well, I think I'll start with that because I think I'd be involved with that. I'd be prescribing, you'd be getting an infusion or a prescription, so I would be notified. And so the first thing is I would hope to have had the discussion with you in advance because often when I write the prescriptions, now our electronic records will pop up.

What's covered. What's not covered. And so the discussion that biosimilars are appropriate. If I didn't think that you should have it because of some complex history problem, I would have that discussion with you. And that I would do an authorization request to deny that switch. So what can you do as a patient?

I think one go to the prescriber. They need to know you can call and leave a message or use your portals, etcetera. To ask them very concretely, don't say, what should I do? Is this okay for me ask a concrete question. Is it appropriate for me to switch? Do you have concerns maybe a phone conversation or something or a visit or whatever.

That's a place to start. The other thing is that insurance carriers and policy makers need to hear from people who are unhappy. So. Put it on your agenda to say, if you're unhappy with something to write a letter of complaint or an email of complaint. So because if you never complain, then you can't complain about the results.

You know, it's an important concept. So I think I would want to be contacted first. I do think that you should go to valid information sources, Infor agencies, organizations that validate their information rather than just someone. Sales site or somebody who's got an ax to grind because there's so much wasted.

Time and energy on the internet or whatever. And you shouldn't waste your time. There life's too short. 

Michael Reilly: I, I would just say that, you know, as I listened to this conversation, I, I, I had kind of a unique perspective when I was at HHS because I was both, I worked in the secretary's office, but at, I was there when we were creating part D.

And so I was involved in both the development of the part D and then the, the, the kind. All of the media component of part D and then literally taking phone calls from Medicare beneficiaries on part D and questions they might have. And I think it, it really I was also there when, when there was the vaccine shortage.

And so we actually did a campaign that traveled around with the surgeon general and answered people's questions. And the biggest challenge really is that each individual. Has a question that is probably representative of some other person. And every question is valid. But how do you get information to them in a way that they, you know, sometimes it's just a lack of trust, you know, as Dr. McKibbon says about, well, what, where do you go? So, you know, really biosimilars has been fairly heated as this has all evolved over the period of time. And we at ESPN, I'm a PO a former regulator policy person said I want everything to be. That you can a answer any question we can point to a resource. We have been very data driven.

We've been based upon surveys from physicians and really talking with the patient community. And so, you know, what I would say is what is the first thing you do? I think of the first thing that met, I literally met many, many Medicare beneficiaries and it was really unique experience to understand that the individual, you know, when we were dealing, developing that policy, we would say, well, You know, this is really complicated.

You don't know what each individual patient wants. You don't know what is important to each individual patient when we are developing part D it might be, I care what pharmacy is closest. I care, you know what? It's not always as simple. It doesn't always come down to money. It doesn't always come down to, you know, one particular thing.

And so recognizing, you know, I would, I would say multiple resources is important. Packaging resources is important, but ultimately we all have an obligation and certainly, you know, would. ATB wanna get information out there and we make ourself accessible. And I think that's really, you know, I think patient community you know, is a really good place to start because they're coming at it from the perspective of understanding the needs of the patient.

So you are a patient. Andy is someone who really understands the patient perspective, not only from his own experiences. Personally, but also from his life experiences. And I think, you know, I have a brother who, who died of thyroid cancer. We've all had someone who's been affected. And I think it's just, you know, really taking that to heart, that our job is to assuage people without fooling people.

And, you know, I think that's, that's the role. And ultimately, you know, you, Tiffany are probably, and Andy are best situated in, in, you know, my experience as a regulator and Dr. McKibben's as a physician. We all have different shoes that we're, that we have stood in. But we need to understand that we all kind of ultimately should be working for the patient because that's ultimately what this is all about.

No matter where you are standing, this is about access and about treatment and about, you know, providing a level of comfort and, and trust because if they don't trust you, then basically it, it, it affects every aspect of their.

Tiffany: Absolutely. I wanted to the in addressing Dr. McKibben's questions and, and advice on what to. Ask, there is a great resource from the biosimilars training program, a patient advocacy toolkit that we've actually referenced a few times today, even if we didn't say it and has a lot of information on education on what is a biosimilar, what is non-medical switching, what we've talked about, and it has a sheet.

Of questions that you can ask. And I was looking at it yesterday and it there's quite a few questions. It's, it's something that I think could be very customizable too, to your unique needs. So we will make sure that we have a link to that toolkit because it has that in there. And it's in maybe on one of our breakout 360 it's we'll do a we'll walk through it and.

We'll do our own little tool kit. But so Andy, I wanted to also turn it back to you for any last comments or. Any plugs for some great takeaways or resources 

Andrew Spiegel: as well. Yeah. I mean there's nothing I could add to what Michael just said. I was ready to stand up and, and applaud everything he just said, because what he said was that no matter what shoes you wear in this whole arena, and there's a lot of stakeholders in this biologics and biosimilars arena over.

0.2 billion patients around the world have re have taken a biologic medicine. You know, these things are, these things are transforming patients' lives. These are making kids with disabilities who couldn't get out of a wheelchair now playing sports in school, and these things are curing other diseases.

So, I mean, these are the real deal. These are here to stay. These are the next 10 to 20 years of. As the new breakthroughs come out. And as long as everyone understands, whether you are a payer, a manufacturer, a patient, a regulator, a policymaker, a physician, everyone must remember that it's the patient that's taking these medicines.

It's the patient. Who's sick. Who's got a disease. Who's taking these very complex medicines and that should be the main concern of every aspect of biosimilar policy development, whether whether you are a stakeholder in it for profit or to help patients. None of it should matter. Everybody has to be concerned about what's interest.

What is in the best interests of the patient taking these medicines. And, and I think that everything you've heard today, and then the resource that you've mentioned learned biosimilars.org. You could find everything you need to know about biosimilars from terminology, glossary of terms to patient stories.

You'll hear from patients to, as you say, this whole toolkit that you can take away. And advocate for yourself to make sure that make sure you're on the right medicine and, and the people that you represent, if you're an advocate are on the right medicine for them. So with that, I'll close it out from a, from my perspective.

Tiffany: All right. Wonderful. And I am looking at a very, very large list of amazing resources sitting in front of me. And I just want to confirm. I see a lot of video white pipes. Are these all available on the website that you mentioned? I see a lot of head shaking. 

Michael Reilly: Yeah. Say biologics.org is we have the surveys that Dr.

McKibbon reference the webinars that we just completed. We have written a number of white papers which rarely were the basis for the webinars. We just did. Dr. McKibbon and I are just finishing up another white paper on the us physician survey that will be coming out soon. So yeah, lots of resources there, videos, et cetera.

Anything you need and if you have any questions in particular, there's a way to get to us as well. And we are always standing. All 

Tiffany: right. Wonderful. And you can also visit us@aiarthritis.org. And there is a biosimilars page where you can ask questions, our biosimilars hotline, and we will, of course have all of these resources attached to this episode and all of the breakout 360 at conversations that we plan to have to keep this conversation going.

So in saying that I wanna. All of my guests. Thank you, Dr. McKibbon. Thank you, Andy. Thank you, Michael, for being here, this has been absolutely amazing. You all have been outstanding, so thank you. 

Michael Reilly: Thank you, Tiffany. Thank you. Thanks for enjoyable. All right. Thanks Dr. McKibbon, 

Michael Reilly: soccer game. you have a great weekend.

Good luck, Andy. Thanks. 

Tiffany: Thank you. Bye guys. All right, bye bye.

And then there you go. That is a wrap. So you can find this and all of our episodes@aiarthritis.org. Just look for the link to our talk show. And while you're there, feel free to give a donation because it is your support that keeps episodes like this going.

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