Biosimilars have been a trending topic in 2023 with 8 adalimumab biosimilars expected to hit the market this year.
It’s no secret that biosimilars are a hot topic in 2023. In dermatology, at least 8 adalimumab (Humira; AbbVie) biosimilars are expected to be available this year. Already, adalimumab-atto (Amjevita; Amgen) became the first adalimumab biosimilar available last month.
Cardinal Health, a pharmaceuticals distributor, global manufacturer and distributor of medical and laboratory products, and a data and performance solutions provider headquartered in Dublin, Ohio, recently released its 2023 Biosimilars Report, reviewing the changing landscape of biosimilar use among rheumatologists, gastroenterologists, ophthalmologists, and dermatologists. Most notably, the report focused on adalimumab biosimilars in 2023 and how comfortable physicians are with prescribing adalimumab biosimilars.
Bruce Feinberg, DO, chief medical officer of Cardinal Health, spoke with Dermatology Times® about the research that went into compiling the 2023 Biosimilars Report, how adalimumab biosimilars will change the way dermatologists treat patients, what he hopes physicians take away from the report, and more.
To view the full 2023 Biosimilars Report, click here.
Bruce Feinberg, DO: I’m Bruce Feinberg, I’m a medical oncologist by background training, but for the past 12+ years, I've served as the chief medical officer for Cardinal Health, and in that role I wear a bunch of hats, but my passion is around research, particularly market-based research of clinicians, but also real-world evidence research to actually look at their perceptions of care, their actual care, and then based on their chart analysis, and then levels of evidence and how that influences both. So, in this particular case, the focus is around their perceptions and behaviors in regard to the adoption and use of biosimilar drugs. And that's the nature of our 2023 report. It was inspired by our 2022 report. So, some 7 months ago, we released our first biosimilar report. And it turned out that it was very well received in the marketplace. We do a tremendous amount of market research of clinicians. We often use that internally to understand the marketplace, Cardinal being one of the 3 large drug and device distributors, but as a result of the time, they've also expanded into much more broad diverse healthcare consulting work. So, it's very much influential to our understanding of the marketplace to do that research. But we realized that as many of our clients had questions about biosimilars, it was timely. And so, in 2022, we did release our first report. It was very well received in the marketplace and there was, at the time, a clamor to keep this information coming. We thought this particular time was a very appropriate time. Lots of things have changed in the marketplace, which could be very influential to the world of biosimilars. Biosimilars are now approved in multiple medical specialties, particularly now 2 major things are changing: one, the single largest most prescribed drug in the world, Humira, has come off patent and after lengthy legal battles since 2016, biosimilars are entering the marketplace. There may be as many as 6 Humira biosimilars to come to the marketplace. This is a worldwide $20+ billion drug. Also unique to these drugs coming in the marketplace, one of the biosimilars of adalimumab has been granted interchangeability, which we'll get into I'm sure the conversation, which is unique designation among biosimilars. And so, we've got that one storyline, that's very important and timely for why the report now, the second is the sunset of the oncology care model; one of the largest markets for biosimilars has been in the world of cancer medicine. That was the disease state in which the first biologics were launched, those early entries of biologics into the market, have now exhausted their patents. And so, as a result of those drugs, being in the market now, for a matter of years, we do have a chance to really look at a robust, mature market. But that market was influenced dramatically by the oncology care model, a CMS payment program that created a Shared Savings Initiative in which providers could benefit in bonus dollars based on not just the quality, but the cost-effectiveness of their care. And there is a tremendous uptick in biosimilar prescribing, within the participants within that program, which in the end, that program resulted in almost 50% of Medicare recipients with cancer being treated within that program. So, we have two big things changing right now. We have the sunset of the oncology care model. It's soon replacement with the enhanced oncology model, the new CMS program to replace it. And then we have adalimumab coming off patent with its large number of biosimilars, one of which is designated as interchangeable, so lots happening within the biosimilar marketplace that felt that it was very timely to get that report out now.
Dermatology Times®: How do biosimilars (such as those available for adalimumab) change the treatment options available for patients?
Feinberg: So let me begin by saying that the way that we come to our conclusions is based on fairly robust market research. And so we are focused on the prescribing physicians, not allied health professionals in their practice. Our research for this report is done with the physicians, not with the pharmacist, the nurses, the administrators, the advanced practice providers, and there are 350 positions, somewhat equally divided Amongst dermatologists, rheumatologists, gastroenterologist ophthalmologist who treat retinal disease, which is a different class of drug than adalimumab, but nonetheless there and not in this report, but in the prior reports, cancer. So it's robust research across different specialties who prescribe in the case that we're talking in this case, adalimumab, and what we're learning from them is that the willingness to prescribe a biosimilar is pretty high, and that the barriers and the challenges to prescribing are really not front and center, but they also don't think of all their patients as equals. And so, there is the patient who is newly diagnosed and felt to be a buyer to be a candidate for a biologic, what's called a biologic disease-modifying drug or a biologic DMARD. And there's little hesitancy in using biosimilars in that regard. There are also patients who had already initiated a biologic DMARD and who have achieved disease control, to move them off their reference branded drug to a biologic is really a separate class of patient with a different question. And there is some hesitancy in doing that and making these wholesale changes. So, we talked about adoption, generally few barriers to consideration of use, but there starts to be nuance in which patient and in what clinical scenario.When it comes to the number of biosimilars coming to the market, clinicians in general across the specialties seem to have a general feeling that the FDA approval processes are sound, and these drugs as a class of biosimilars are generally equivalent. One thing that does stand out is an FDA designation of interchangeability as I mentioned earlier. Interchangeability is, from a standpoint of the way we need to think about it, in the history of pharmacology and drug manufacturing and drug development. Once drugs were issued patents, and there was a patent life, when that patent expired, another manufacturer could manufacture that drug.When it was a small molecule chemical, we will take aspirin, for example, 21 atoms strung together in a particular sequence, then it was fairly easy to do bench chemistry. And for another manufacturer to string those same 21 atoms together. The pill they made from that could have a different size, a different color, they might have chosen to offer that pill at different milligram strengths. So, it might not be an 81 milligram, they may choose to make it 100 milligrams, but it was still aspirin, chemically identical. And so that's what allowed for the designation of generic. Biologics are very different. They're very large, complex molecules, not 10, 20, 30, or 50 atoms, but 20,000+ atoms.They can't be easily manufactured doing bench chemistry. You need biologic systems to make them. And so originally, they were coming out of the milk of sheep or cattle, we were able to figure out, we being the broader class of researchers, how you could use any biologic system. So, you could use a bacteria or yeast. And now we have vats of E. coli, or vats of yeast that are producing these complex molecules. There are small variations batch to batch, every one of those batches gets tested for proof that it is identical enough to be considered the same drug. But that variants batch to batch of the branded drug meant there would be variants batch to batch of the biosimilar drug, which made it difficult for the FDA to say we can't call them identical. They're not. So, we can say they're similar. And then we can say you have to undergo a certain amount of formalized research, like clinical trial research, in order to prove that is more than just similar, that in the clinical setting, it behaves exactly the same as best as we can tell to the reference brand. But if you can prove it, in a reasonably sized population, you don't need a comparator. And you don't need to compare against the reference brand directly. Just prove that your molecule seems to act just like the reference brand molecule. So biosimilars come to market with this understanding of non-inferiority. They're not proven or compared head-to-head at this point in most cases, and smaller populations and not across all the disease states in which they're indicated.Adalimumab has indications for rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease, the list goes on. And so, you just had it proven one population of patients. So, for clinicians, that's a little different to say, why do you want me to change from a drug that I've been using for two decades that I'm comfortable with, that I see it's effective. I know it's safe. With the amount of evidence that you're providing me, there's no great impetus for me to change.The impetus was supposed to be economic, that biosimilars are going to lower the cost of health care. And if that is the impetus, where does that get? Who experiences that benefit? Does the patient experience the benefit? Does the physician in some way experience the benefit? If it is society? Do we know that that's the case? So, these are some of the hurdles and barriers.One of those barriers I mentioned was lack of head-to-head comparison.As the number of adalimumab drugs gets to be considerable, one of those manufacturers decided to take on that challenge and do a more robust, much more costly clinical trial in which they compared their biosimilar directly to Humira.As a result of that, and the evidence which proved that drug was equally effective and equally safe, the FDA did grant them interchangeability. So now even among the biosimilars they're not all the same.There is now a biosimilar of adalimumab that the FDA has granted interchangeability. And there are biosimilars which are FDA-approved, but not designated interchangeable. So, we have a lot to kind of see in the next 6 months and year, which will be accompanied by more reports. Do these differences make a difference? Do they make a difference in adoption? Do they make a difference in adoption, specifically in different clinical scenarios, like new patient prescribing and switching.
Dermatology Times®: Do you anticipate that the numerous adalimumab biosimilars coming out in 2023 will oversaturate the market?
Feinberg: So, you know, it's hard to know what does oversaturation mean, right, you have a $21 billion, you know, market worldwide. Any drug that gets a billion dollar market, you know, has hit a homerun. So, if that's if they could share equally, we could have 20 biosimilars of adalimumab, and we'd have lots of homeruns. I don't know what it means for oversaturation. From a marketplace perspective, the question is, with the drugs coming out, again, how will they differentiate themselves. We already know that one has gone the route of spending more money on its research, in order to get an interchangeability designation. How much will that impact? And will that force others to do the same? For those that don't? Will it be a pricing-based competition? And if so, how low does it go? I don't think we know and that's why it's going to be fascinating to watch over the next 6 to 18 months. These drugs will come out over the course of the year. And I don't think the full story will be not will be known until about 18 months, but keep looking for our reports, because we'll be keeping you up to date with what we're seeing.
Dermatology Times®: What statistic or milestone from the 2023 Biosimilars Report are you most pleased with?
Feinberg: So what pleases me might not be what would please someone else. My concern is that we are doing high level quality, unbiased research. And particularly with adalimumab, given you know, there are the big stories, I think that EOM is an equally big story. But it wasn't as much the focus of this issue. I was particularly intrigued around the issue of switching. I think this notion of we generally believe these drugs to be the same. And if I'm going to start a patient, and I'm being told by my payer, that the preferred agent is x, whatever that biosimilar may be, I'm okay with it. But if I have a patient who's in their third year, and they had rip-roaring disease at presentation, and they've had total disease control now for a long period of time, I'm a little bit hesitant of making a switch to an agent I've never prescribed before, because a payer tells me that that's the product of choice in the formulary. And when we asked that question, we got different answers. When referring to switching, 18% of rheumatologists were favorable to switching, so you know a minority, a small minority, 36% of gastroenterologists and 50% of dermatologists. So, you would think well, why would doctors be different? Why would their specialty, you know be different? Some of that maybe is the amount of exposure they've had. Rheumatologists had been using more biosimilars for a longer period of time. Is that part of the basis for it? Is it the nature of the disease? The fact that switching is still a prevalent issue and a challenge for providers and that number2, by specialty, it's not the same, was probably the most pleasing because it makes me feel that we're asking the right questions, we're getting to, you know, what are the meaty areas of this, and not just being kind of superficial and where we're trying to understand the marketplace.
Dermatology Times®: Overall, what do you hope physicians take away from the 2023 Biosimilars Report?
Feinberg: So the first thing I'm hoping they take away is the actual report. We know that industry is very interested in this work. I would love for physicians to be interested in this work as well. Through our development of when I call them communities, but specialty communities, in which in order to conduct this market research, you don't want to just cold call people. So, it's great if you can build a relationship and have a community of providers that you work with and periodically engage. We send them newsletters, we review the content of their national meetings. So, we're building communities among these specialties and be able to reach out to those communities, I not only want them to be available, when we conduct the research, but I'm hoping that they're also going to review the results of that research and be able to get more feedback from them. So, my number one is that they take the time to look at this, and not just get caught up in their own feedback loop of whatever they do and their partners do in their practice. And then the other thing is, I want to make sure that because of that community, if there are things that we aren't asking, if there are issues that we're missing, that they bring it to our attention. Because it's critical in our future work. And again, just like as they get caught up in their in their loops, we can get caught up in our groupthink. And if we're convinced that we've covered it all, and sometimes you miss some things that are really that may seem really basic, but are still prevalent.
Feinberg: I want to just reinforce that our goals with this is one to do robust research, to really do good deep dives, to do it on a scale that's going to be meaningful. In this case, 350 physicians were surveyed across 4 specialties. So, it's a high bar for us to be able to maintain. But our goal is to is to maintain that high bar and continue to put out these reports at a frequency which is really helpful in being able to understand the trends in the marketplace and do it in a way that's not just at a high level for business, but at a deeper level where it has clinical impact as well.
Transcript edited for clarity