Psound Bytes™ Podcast: “Latest News About Biosimilars” A Biosimilars Forum sponsored episode.

Shiva: My name is Shiva Mozaffarian and today’s episode sponsored by The Biosimilars Forum will present how biosimilars play a crucial role in treating chronic conditions and lowering prescription drug prices. This episode is being offered as a way for you to hear directly from the Biosimilars Forum and may contain information about a Biosimilars Forum offered product. From time to time, NPF will share sponsored content that we think is of benefit to those with psoriatic disease. NPF encourages everyone living with psoriatic disease to work with their health care provider to find an appropriate treatment for them. NPF does not offer medical advice and this podcast should not be considered an endorsement of any particular product or treatment. I’m here today with Julie Reed, the Executive Director of the Biosimilars Forum. Julie, it’s so great to have you here with us today! Before we talk more about biosimilars, can you please explain what the Biosimilars Forum is and what do you do?

Julie Reed: Thank you so much Shiva. I cannot tell you how excited I am as the Executive Director of the Biosimilars Forum to represent the member companies that are part of the Forum and it's such an honor. So let me tell you what we do. We are a nonprofit trade association dedicated to expanding patient access to life saving biosimilar drugs. We work with policymakers and stakeholders to create policies that encourage biosimilar awareness, education and adoption. First and foremost our member companies and the Biosimilars Forum are all about lowering prescription drug costs per millions of Americans that need them. We're about increasing access to life saving lower cost medicines. I can't tell you for me how important that is and I'm sure for all the patients we're talking to, how important that is, especially today. Imagine a group of pharmaceutical companies engaged in wanting to lower cost of medicines. We're also all about educating patients, providers, employers, payers on the safety and efficacy of biosimilars which is so important. Then, because we're about policies and increasing patient access to these vital lower cost medicines, we engage with the administration and other lawmakers to implement policies that will promote biosimilars and get these medicines to patients. We also work with regulatory bodies like the FDA to advance biosimilars and make sure that the science is there, and the best quality and safety regulations are there to bring safe and efficacious biosimilars to patients. So that is what we do and it's for the patients we serve.

Shiva: Well thank you for pursuing lower prescription drug costs and access to treatments which is so important for our community. So while we spoken about biosimilars in the past on Psound Bytes™, can you please refresh our memories – what is a biosimilar?

Julie Reed: Great question. Always happy to talk about this and what they are. I think one of the most important things is to know that the biosimilar is approved by the FDA. But let me talk a little bit more about the science and biosimilars. First of all, biosimilars are biologic medicines. So they're created using living cells, biologics. The key there is a biosimilar as an FDA approved biologic medicine has no difference in the safety or efficacy of its brand counterpart. So that's something patients should feel very confident about and it's going to be lower cost. Super important. Most biologic medicines and therefore biosimilars are administered by injection or by infusion in the doctor's office or some other type of infusion center. They became available in 2006 and then a group of our member companies told the US we need to do this too. Patients need access to these lower cost medicines. So we worked to pass the law that authorized the FDA to approve biosimilars, which is the “Biologics Price Competition and Innovation Act” or for short it's BPCIA, and we passed that in 2010, which was extremely exciting. It takes 6 to 8 years to develop a biosimilar, so the first biosimilar in the US was launched in 2015 and we're excited that our member companies continue to develop these products and bring them to patients in the United States. Now psoriasis is one condition biosimilars can treat. But we now have biosimilars in cancer, arthritis, Crohn's and colitis disease, kidney conditions, but also the first ophthalmology biosimilar was launched just this month. So it's very exciting to see competition, FDA approved biosimilars on the market lowering prescription drug cost. It's an exciting time for patients.

Shiva: Yeah, it’s definitely an exciting time. So you mentioned biosimilars are FDA approved. How are biosimilars confirmed to be safe and effective?

Julie Reed: That is the job of the FDA and that is so important. Developers of biosimilars were required to meet the very stringent scientific and regulatory controls of the FDA and have to prove to the FDA are biosimilars are as safe and effective as their brand biologic. So all of our FDA approved biosimilars undergo a rigorous evaluation so that the health care providers and patients can be confident of the safety, effectiveness and quality of biosimilar products. As part of the approval process for both the brand or reference biologic and the biosimilar FDA assesses a manufacturer strategy to control for the pattern and the degree of any variations between the two different products so that safety and effectiveness don't change. That's really important for patients to know and to expect. The FDA evaluates each biosimilar on a case-by-case basis and advises our manufacturers on the scope and extent of testing needed to show biosimilararity. As I mentioned, it takes 6 to 8 years to get all of these evaluations and everything else done to get approval of a biosimilar. It's expensive, but there's nothing more important than to provide the best quality, safety and efficacy in any medicine in the United States.

Shiva: That’s definitely a key point. So I'm curious, what does the biosimilars market look like?

Julie Reed: It is very exciting. So in just a few years we already have 35 approved biosimilars in the US, 21 of them have launched. We’re waiting for a few more to launch, which will be coming up next year. We have three biosimilars in the oncology supports area and we have another three biosimilars treating directly cancer. We have four biosimilars in the therapy area where psoriasis falls into, and then as I mentioned earlier, the first ophthalmology biosimilar just launched this month, which is an incredible opportunity.

Shiva: Absolutely. And what are some of the key US biosimilars milestones?

Julie Reed: So I'm gonna age myself and say one of the first ones was in 2010 when we were able to pass the BPCIA, the law that gave the FDA the authority to evaluate and approve a biosimilar and set up the entire biosimilar program at the FDA which did not exist until then. So that's the first one. The next one was in 2012 when the FDA released the first guidance to manufacturers that said this is how we're going to approve and evaluate biosimilars in the US. And this is really key that bipartisan Congress passed this program because it's so important to bring lower cost prescription drugs to Americans. So the next thing is the first biosimilar in the US from one of our member companies, Sandoz “Zarxio” launched in 2015. In 2021, the FDA announced and approved the first interchangeable biosimilar for insulin. And then I think one of the key milestones that everyone should be excited about is next year we will see the first biosimilars for Humira being launched and there are at least 7 going to be launched in the US. Incredible 15 years. It's been a great journey. And again, like I said, there's nothing more important than lowering prescription drug costs in this country. So very exciting.

Shiva: Thank you so much Julie for providing this background information about biosimilars. You mentioned Humira which is a biologic most people with psoriasis are familiar with. What other biosimilars are coming that can be used for psoriasis?

Julie Reed: Sure. So going back to that one and where I hope patients are excited about the prospects of costs being lowered next year and getting access to these biosimilars. So these are always interesting names, how developers name products, but so Humira is the trade name. The drug name for Humira is adalimumab. That's the actual drug. So there's going to be biosimilars to adalimumab called Amjevita launching. Another one called Abrilada. Another one called Cyltezo, and another one called Hyrimoz and these are all going to be biosimilars to adalimumab. But there's other drugs that psoriasis patients may be receiving, and one of those is Enbrel and that's etanercept. Now there are at least two etanercept biosimilars that will be available soon. One is Erelzi and the other is Eticovo. And then the other ones that are currently on the market today for psoriasis patients is to the brand Remicade which its drug name is infliximab. And so infliximab has Avsola, Inflectra, Ixifi and Renflexis. So quite a robust amount of biosimilars are either on the market today or about to be that will bring lower cost products and availability to the psoriasis community, which is very exciting as these are costly medicines and lowering costs for patients is what this is all about. So great question and very exciting times right now.

Shiva: So you mentioned lowering costs which is certainly of interest to our listeners. How will the use of biosimilars save money?

Julie Reed: These are FDA approved biologic medicines coming to all of you and they are coming at a lower cost. So we know that our experience with the biosimilars today, not just in the US but around the world, is that the competition from a biosimilar is lowering the cost both for the brand biologic but also the biosimilars which is great news. It's working. So launching them is really important. We also have seen that when we do have lower cost, more patients can access these products, patients that may have never been able to access them because cost was prohibitive which is such a great thing to see that more patients could get necessary medicines. We've had economists continue to study the potential across the board and as I mentioned earlier, we've got the Humira biosimilars launching next year and economists predict there could be at least $133 billion dollars in savings by 2024 just from biosimilars. And that's an incredible amount of money to save taxpayers, consumers and patients. But that's only if we see that patients have access to the biosimilars. So that's really key and something that we'll talk about in a little bit. So we know that the first biosimilars on average launching at a 30% less or 30% discount from the brand biologic and then we know that after more biosimilars launch per competition, those discounts go from 30 to 40 to 50 to 60%. So that's where we know the more biosimilars out there competing with the brand, the more savings we're gonna see here in the US.

Shiva: Well lower costs is great news. So what’s the impact of biosimilars on the U.S. market dynamics? Can you talk about that a little bit more?

Julie Reed: Absolutely. Here's the thing. What we know about biosimilars and the market dynamic and what I think is so important. What would happen if we did not have biosimilars launching in the US and if we did not have the competition on the brand drug. And the Biosimilars Forum looked at what would happen if these biosimilars did not launch? What would the brand drug do and what would happen without the competition? The brand drug increases its price. And so I'll give you an example of one of the Cancer Support biologic medicines, Neulasta. We have had an economist study that predicted without the competition of biosimilars Neulasta would have raised its price by 96 percent in April of 2021, if there was no competition. Right now there's four biosimilars competing and the price has gone significantly down. Another example, and this is in the psoriasis space is what would happen if Remicade didn't have any biosimilar competition? And the economists predicted that without competition, Remicade would have raised its price 150% so that is what the dynamic is. We all know competition and drugs and now it's proven to happen with biosimilars bringing competition lowers the price both of the biosimilar, but also the brand and so that is crucial - we know the competition works.

Shiva: That's so interesting and it’s good to see the impact of that change. While we've heard some of these terms before, can you explain the difference between reference products, biosimilars and interchangeables?

Julie Reed: Absolutely, because I think this is an area where I think patients get confused and that's unfortunate. So, the reference product is the brand biologic that is already approved by the FDA and that is what every biosimilar is compared to when they are evaluated and approved by the FDA. So the biosimilar is the biologic that is highly similar and no clinical meaningful differences. It has the same safety and efficacy as the reference or as its brand biologic reference. So it's called reference because the biosimilar is always referred back and compared to the brand. So think of it that way. Now, interchangeable biosimilars. This is unique and very confusing. Interchangeability is in the law, and it has nothing to do with the clinical safety or efficacy of a biosimilar. All interchangeable biosimilars and all biosimilars that are not interchangeable have the same level of clinical safety and efficacy in patients. So patients should know that. That is baseline and that is the requirement. An interchangeable designation is only meaningful if the biosimilar is going to be dispensed at a retail pharmacy. So you go up to the counter at your neighborhood pharmacy to pick up your drug, and today the pharmacist is allowed to substitute and give you a generic version of your drug if the generic is available without calling your doctor because the products have the same safety and efficacy. It's very rare that you will get a biosimilar or its brand counterpart at the retail pharmacy counter at your local pharmacist. But if you do, and the pharmacist wants to substitute it, that biosimilar will have to have an interchangeability designation. It's about how the product can be dispensed and substituted by the pharmacist without the doctor's permission, and that is what an interchangeable biosimilar is. Now, again, I'm just gonna reemphasize the biosimilar or the interchangeable biosimilar have the same safety and efficacy and have been tested against the reference product. Interchangeability only is meaningful if you're going to your retail pharmacist and the pharmacist wants to substitute. We encourage all doctors to be part of that decision. The Forum is also encouraged that if a pharmacist in any state is going to substitute a interchangeable biosimilar, they need to be sure the patient knows, but also the physician knows what interchangeable biosimilar they're receiving. I hope that makes sense. It's a difficult concept, I think.

Shiva: You’re absolutely correct. Interchangeability is a difficult concept. So while you've just explained what it means, can you address some of the myths and facts associated with it?

Julie Reed: I love this question because I think it's a great way to dispel the rumors about interchangeability. So an interchangeable product, again it's your retail pharmacist wants to substitute and give you an interchangeable biosimilar without getting approval from your doctor. They can only do that if the biosimilar is designated interchangeable by the FDA. So interchangeable biosimilars do have to do some additional requirements, because now the pharmacist is making the decision, not your physician and it depends on the not only the FDA requirements (so we do some extra switching study) but they also have to by law in their state be able to do that. So again I think that that's really important to understand. But there's some myths when folks hear that FDA have additional requirements, again focus on the fact that the pharmacist is making the decision on what medicine you get not your physician in this case. When folks hear the FDA had additional requirements, well, it must be better than the biosimilar and that the answer is no. So myth number one, interchangeable biosimilars are no different in quality than their brand or reference biologic. The quality standards across all three are the same. There is no quality difference between these products and the FDA would never lower its quality standards for any American. So I think that's really important. Myth number two, “well, if it interchangeable, it's gonna have a better effect on me clinically. And the answer to that is no. So the myth that any clinical performance of a interchangeable biosimilar would be better than another biosimilar that's false. We are held to the same standard of clinical performance whether a biosimilar is interchangeable or not as the brand biologic. FDA does not lower standards for any biosimilars. The standards are the same. So another myth that we hear is well, I'm on a biologic and I don't think I should take a biosimilar, just start the new patients on biosimilars. That, too, is false. Patients should feel confident that when they are transitioned to a biosimilar, the biosimilar has to have the same quality and clinical effectiveness and safety as the brand or you would not even be offered it. It will not get out of the FDA. So feel confident about that and new patients should feel confident. Existing patients should feel confident and feel excited I think about a biosimilar, especially if it's lower cost. You're finally going to get a cost break. So that's important. Bottom line, the FDA is not going to lower standards and biosimilar developers are not going to lower standards either. This is medicine. So you should feel confident that we too support rigorous standards, especially for these critical medicines all of the patients and the audience here are using. So finally another myth is about the location. Interchangeability is only relevant to biosimilars that are dispensed in retail pharmacy settings when a retail pharmacist wants to substitute an interchangeable biosimilar without calling the doctor. So you gotta come back to me, Shiva, and tell me after this podcast what our audience thought. Maybe we can follow up on that. Maybe that'll be a follow up podcast for us.

Shiva: Yeah, that’s a great idea and thank you for addressing the myths and facts that come up when talking about interchangeability. So are there additional resources to help understand the terms if our listeners want more information?

Julie Reed: I wanna really call out and thank our partners at the FDA. The FDA is taking a strong and very proactive amount of time and work to educate patients and providers about biosimilars. I highly recommend to this audience that you go out to the FDA website. You can also go to the Biosimilars Forum website so that you can get the materials that the FDA has put together directly for patients or for your doctors that explain this as well. So I think it's really important to hear from the authority, the FDA, who is by law evaluating and regulating biosimilars. They're the source of the education on all these things. But I'll tell you that the biosimilars forum uses the FDA materials in our education as well and they are usually present in all of the education programs we do because again, they’re the authority and there's nobody I think more important in this conversation then the FDA.

Shiva: Thank you so much for that Julie. So we've spoken today a lot about biosimilars. Let's now shift to a discussion about policies. What policies does the Biosimilars Forum support? Let's start with a discussion about add-on payment.

Julie Reed: Absolutely. As I mentioned earlier, the Biosimilars Forum, we advocate for policies with Congress and in the state level and with a PBM’s. We advocate for policies that’ll improve patient access to lower cost by biologic medicines and biosimilars. And when we started to launch biosimilars we also reviewed what does the market look like? What are the policies these products will be entering, and do we need policy changes so that patients can have access to these lower cost products? I mean that's part of what we all do is to get access to these products cuz this is what it's all about - getting in the hands of patients lower cost biosimilars. And so we looked at the policies and we found policies that are actually barriers to patient access. And so we're like, well, we gotta go out and talk about this and try to fix this. And so one of the things is when a physician administers a biosimilar or any injectable drug, they're paid by Medicare at an ASP plus 6%. (ASP is the average selling price of the medicine.) And if you can imagine well, wait a minute, the biosimilar is lower cost then the brand and if the physician is getting paid ASAP plus 6% and there is a little other math going on, it's actually ASP plus 4.3% today. But if they're getting paid ASP of the brand which let's say is $1000 at plus a percentage and the biosimilar, let's say is $100 and they're gonna get paid more, right for the brand drug. And we're like, well, that's kind of hard for the physician office to make that decision because economically it's gonna be a real tough decision. So we said wait a minute, do an add on, let's help physicians, encourage them to use lower cost products by not reducing their reimbursement so much, give them a little bit more to use the biosimilar. And so we recommended ASP plus 8% for the biosimilars. Now this is key about that. You're going well, no, you're just giving them more money. Actually we know because of the discounts of the biosimilars that if we encourage physicians to use lower cost medicines overall, we're gonna save more money because you're using a lower cost than not a higher cost medicine. And so the more you use the lower cost medicine, the more savings we get. And we've had an economist look at this, this one thing giving the physician an add-on payment, an incentive to use a biosimilar, a lower cost one, that add-on will actually drive greater cost savings and our economist predicts that would save at least $8.2 billion dollars in taxpayer dollars. Because you're increasing the use of the lower cost product. So that's one of our policies. I hope that makes good sense. Encourage using more lower cost things, you encourage savings. What I try to do with my kids.

Shiva: Yeah, that’s a pretty significant cost savings.

Julie Reed: Yes, yes.

Shiva: And how about out of pocket costs for Medicare?

Julie Reed: Absolutely. And we encourage not just Medicare to do this. We encourage everyone in the commercial payor side to do this. But we looked at it from a Medicare perspective and I'll use the analogy of the use of our experience as a country. When payers started to encourage patients to use generic drugs because they knew you were going to get greater cost savings as patients use more generic drugs. And so what payers did was if you choose to use the generic, your copay is only gonna have to be $4. I think I remember when $15 came out and then large companies went to $4. And I think today several of us may have oh it's a generic you don't have any copay and again that's encouraging us as patients and consumers to use a lower cost product. Well, we know this would work too with biosimilars. And so one of our policies that we’re advocating for is that Medicare adopt the same policy. Eliminate the copay in the Part B space and that's because Medicare Part B is the payer for most injections and infusions. We're encouraging Medicare and not just Medicare, but all private insurers to provide patients with $0.00 copays when they use a lower cost biosimilar. Think about that as a psoriasis patient if you were encouraged to use a biosimilar and you would have $0.00 copay for that product, what that would mean to your out-of-pocket cost and your own personal finances. But you know what? You're also going to save billions of dollars overall to our healthcare system and to taxpayers. If Medicare was to eliminate this and then more patients wanted biosimilars, we would see at least $5.2 billion in savings. It's a huge opportunity for all of us.

Shiva: Yeah again, that's a pretty significant savings. So another policy supported by the Biosimilars Forum is a shared savings model. Can you elaborate on what that is?

Julie Reed: Sure. I'm gonna reference my kids on this too and say when you encourage your kids to think, especially when they're young, about how much something costs and you say this is gonna cost a lot of money. How about if we get the lower cost thing and for the money we saved I'll give you some of that savings. That's exactly what this is. And so this is a policy that we would encourage patients and physicians to use a lower cost product and if you do that and we all save money, we're gonna share some of that savings back with you and you can use that money to develop new programs, educational programs. You can use it to hire more nurses, but the savings is yours because it's so important that we get patients access and encourage everyone to use a lower cost product. This type of model has been used in oncology. So oncology shows that it has good uptake of biosimilars because they have had the program called the oncology care model, which is a shared savings program. So oncologists naturally are like we want the lower cost product. So they're very excited and use a lot of biosimilars. We'd love to see this type of program go across into the immunology and rheumatology space or the ophthalmology space. Just do it in all spaces that have biosimilars, so that physicians are encouraged and are incentivized to use a lower cost product. We know this works and our members are global members, they've launched biosimilars all over the world. And I’ll give you an example, in the United Kingdom, they instituted a shared savings program in National Health Service. And because the physicians and hospitals adopted biosimilars, the savings went back to those hospitals and went back to those doctors, and they used that money to hire more nurses to educate and help patients. And I think that's a great way. That's what cost savings and using lower cost products and getting cost savings is all about. Put the money back in the system. Put the money back in patient's pockets. Put the money back in investing in new medicines and giving patients access to innovation, to new medicines, to new cures. But there's only so much money, and that's why using a lower cost product helps us save and pay for the future and I think that's what this is all about.

Shiva: Definitely. It’s been such an interesting discussion about biosimilars and a great update for our listeners. So in closing, what are some of the key takeaways for utilizing biosimilars for psoriasis and psoriatic arthritis?

Julie Reed: Shiva, thank you so much. This has been a lot of fun for me, but I think the key take away and I hope you all hear it in my voice in how excited I am. I hope if anything you take away is to be so excited that biosimilars are here and available to all of you, and more are coming and they're gonna lower cost for all of you. So think about it especially now. Today I've watched the news this morning and gas prices and the market and everything else, and to think about your health and to think about that the FDA and Congress and our companies are out there developing FDA approved medicines that will be lower cost and available to you. The other piece is if you're a doctor, or if you're a patient, if you're a family member, educate yourself. And as I mentioned, check out the FDA website. Check out the Biosimilars Forum website. Feel free to reach back out to the psoriasis team and they'll reach back out to me. We'll make sure you all have the educational materials you need. The other thing is advocate, you all deserve lower cost products and so advocate for biosimilars. Advocate for this competition. Advocate that you have access to these products that's why they're here. They're here for you. And ask your doctor is there a lower cost biosimilar? And if there isn't one, we're happy to take a look at pipelines and tell you when it's coming. So please, please never stop to reach out. We're here for you. The other one is talk to your insurance company. Talk to your PBM. Encourage them also to give you access to these products because these are for you. Our members at the Biosimilars Forum worked with the FDA for every approval they have 6 to 8 years. Think about the dedication our members and these pharmaceutical companies are giving to bring you a lower cost and a safe and effective lower cost biosimilar for the brand drug you're taking today. Make sure you get access to it. And I can't say enough about what an honor it is for me to talk with all of you today and to represent these very courageous companies.

Shiva: Thank you so much Julie for taking time to discuss biosimilars and for all the work the Biosimilars Forum has done to improve access to biosimilars as an approved therapy for those who have psoriasis and psoriatic arthritis and other diseases. It’s truly amazing! We look forward to hearing policy updates as more biosimilars move to market. For our listeners, you can find more information about the Biosimilars Forum at biosimilarsforum.org. If you have questions about treatment options, contact the Foundation’s Patient Navigation Center by email at education@psoriasis.org or call 1-800-723-9166 option 1.

“Latest News About Biosimilars” A Biosimilars Forum sponsored episode.

Psound Bytes™ Transcript: Episode 168

Release date: June 30, 2022

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