The Center for Biosimilars® (CfB): I'm Tony Hagen, senior editor for The Center for Biosimilars®. COVID-19 [coronavirus disease 2019], has disrupted treatment for many patients across the health care spectrum. It comes at an inopportune time for the growth of the biosimilar market, which represents enormous potential savings for patients, as well as improved access to medicine. We spoke about this issue with Jorge Garcia, assistant vice president of the System Oncology Pharmacy Service Line at Baptist Health South Florida. Garcia is also a member of the Association of Community Cancer Centers' Board of Trustees. He discussed how biosimilar access has been affected by the pandemic and what we can look forward to.

During the United European Gastroenterology Week, we heard that mortality is rising, due to the fall off in doctor visits and cancer screenings. How is patient ability to afford care playing into all of this?

Well, I think what's really important to recognize is that this year, throughout COVID-19, oncology patients have not been coming to see their oncologists or there have been less diagnoses been made. And that's been very relevant. In fact, we now try to just run campaigns to tell patients to not delay their oncology care, to come and receive their services, especially diagnostic services, that we have found ways of conducting those tests. So, I think it's hard to tell exactly how that's affecting their ability to afford care.

Perhaps this year, they are seeing less out-of-pocket costs associated with the amount of care that they receive. However, when they do come back, with potentially delays in diagnosis and in need of more complex care, there could be a delayed onset of expenses due to patients not getting health care as frequently as they probably would have, had COVID-19 not happened.

And, of course, with people losing their jobs, they have less family income. Are you hearing from your patients that this is an issue for them? Are they applying for more assistance through the doctors’ offices? How's that going?

I think that makes a lot of sense. And we definitely have that theoretical concern. We have some patients who have lost benefits through their companies. And so, that always becomes an access issue. At that point, we actively try to work with pharmaceutical companies' programs designed to help patients when their financial abilities have changed. But, as you know, that could sometimes be a lengthy process or a process where patients don't quite meet criteria. So, there is a patient-by-patient assessment that needs to be done.

And do you think broader access to biosimilars could help with any of the problems discussed so far?

I think in general, the core value proposition of biosimilars is to reduce cost and to maintain that same high quality of biologics. And I think [after 2020], given all of the added expenses and overall financial uncertainty for health systems in general, pharmacy leaders and other administrators are probably going to have more pressure than ever before to be able to be good stewards of health care costs in general. And, again, biosimilars are like a low-hanging fruit when it comes to achieving some pretty attainable cost savings within a drug class. Biologics are among the highest cost category when you compare them with all drugs. So, I do think that in the future, this may help with the uptake of biosimilar utilization.

Now, there's a low rate of adoption of biosimilars in the United States. How do you think this is affecting the real savings from these drugs at the moment?

So, in the United States, we're only 5 years into this since the introduction of the first biosimilar filgrastim [Zarxio] in 2015. Almost 5 years in, we've seen that there is a relatively low uptake of biosimilar utilization in general. And there are many contributing factors to that. But when we look at the market opportunity, where a reference product is still being utilized but biosimilar options are available, we see that overall, not looking into any product specifically but looking at the entire market, the vast majority of that market opportunity has not been tapped into. So, I think that as health care leaders, it really lends an opportunity for us to try to rethink how we bring down barriers to be able to provide biosimilars an opportunity for higher market penetration.

Biosimilar access…what's happening at the clinic level that might be preventing patients from getting access to biosimilars? Not coming in for screenings might be one thing but, in the clinic, perhaps you haven't got enough time or [ability to] concentrate, because of other priorities, on biosimilar reviews and get doctors thinking in terms of trying new medicines.

Yeah, you bring up a lot of great points there. So, in our existing oncology patient population, for those that already have a plan of care and receive infusions, we have not seen a significant drop in patient volumes. I think patients, relatively speaking, understand that although COVID-19 is a threat, not being compliant with their chemotherapy is also a threat. So, we have to keep a balance there. And, again, our infusion volumes have not been drastically impacted.

On the clinic side, for new patients is where we see a reduction in patient volumes, potentially from patients in the community that are standing by and trying to wait for things to be safer before they come seek out oncology care. And so, probably the initiation of new treatments in general, including biosimilars and other pharmacotherapy, is seeing a slow down with regards to new patients.

I also want to say that specifically for pegfilgrastim and the on-body [Onpro] injector, we are seeing that specific biosimilar sector has been more impacted because of our efforts to try to minimize the number of visits that the patients make to the cancer centers. And that on-body injector does provide the ability to avoid 1 visit. And so, I think in the pegfilgrastim space, the biosimilar options that do not have on-body [injectors], those are definitely seeing a reduction in utilization.

That's interesting. And we're heading into our first COVID winter, or maybe, hopefully, our last, but what we'll see is even more hesitancy among patients to seek treatment and even more careful measures by doctors, perhaps, to make sure that transmission does not occur in the clinic. Can you comment on how that relates to what we were just discussing about Onpro injectors?

I think what we are probably looking at is as we continue to monitor this pandemic and as we see that the risk level is lower, practices will probably begin to shift back to more of the prefilled syringe products, because, again, that's where the cost savings are. We do not have an on-body injector biosimilar that allows us to have those cost savings. So, in the market today, the only on-body injector is the reference product [Neulasta Onpro], which we know comes at a premium cost.

So, I think as soon as the number of [COVID-19] cases begins to go down—of course, this is very specific to the geographical area—practices will probably try to make a determination as to when it's back to start shifting back to the prefilled syringe so that there could be those cost savings to the practice and to the patients themselves.

Are you interested at all to see how biosimilar usage patterns may change once the data emerges on the pandemic and how that has affected drug use across the board? Or are you already seeing signs? You just described pegfilgrastim, which is a great example, but is there anything else that you're seeing in terms of usage or anticipate?

[I haven't seen] a clear trend on how the pandemic is specifically playing a role in biosimilar adoption. I would probably anticipate that overall this year we have seen a slowdown. We are not going to conferences in person. We are not having discussions as actively as I have seen before in the marketplace to transition to new biosimilars.

You mentioned something that is key before and that is that there's a number of different priorities this year. And so, on the practice side, the leaders that would lead a biosimilar implementation have a number of other things they need to worry about. And so, I think from that standpoint, we are probably seeing less efforts and energy being devoted to the implementation of biosimilars overall. Probably next year, as we get a vaccine and probably move more into our plan for how we transition our practices back to normal, I think biosimilars will be a part of that agenda. How do we transition back to normal with some cost savings along the way?

To watch part 2 of this interview, click 

Videos

Jorge Garcia, MS, assistant vice president of the System Oncology Pharmacy Service Line at Baptist Health South Florida, discussed how the pandemic has interrupted oncology care for patients and affected the utilization of pegfilgrastim biosimilars.

Jorge Garcia Talks About COVID-19’s Effect on Pegfilgrastim Biosimilars

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of November 9, 2020.

Number 5: Investigators at the American College of Rheumatology (ACR) Convergence 2020 meeting 

 of what they say are successful, first-time tests of a multibiomarker disease activity (MBDA) score in patients with rheumatoid arthritis (RA).

Number 4: Medicines for Europe, a generic and biosimilar trade association, contends in a 

 that legal and regulatory loopholes increasingly keep competing drugs off the market

 including one on application methods for Celltrion’s adalimumab biosimilar (CT-P17) were reported at the ACR Convergence 2020 meeting.

Number 2: Alberta, Canada’s deadline for switching patients to biosimilars is months away, but the province has already seen 

 at the ACR Convergence 2020 virtual meeting included data from safety and efficacy trials for Pfizer and Celltrion versions of adalimumab.

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of November 9

To watch part 1 of this interview, click 

The Center for Biosimilars® (CfB): I’m Tony Hagen, senior editor with The Center for Biosimilars®. Today, we’re talking with Nabeel Khan, MD, an associate professor of clinical medicine with the University of Pennsylvania, and an author of a retrospective, real-world study that demonstrated safety and efficacy for patients with inflammatory bowel disease [IBD]. They switched from reference infliximab to the biosimilar Renflexis, or from biosimilar Inflectra to Renflexis. The findings showed a high rate of continuation for patients on Renflexis. Findings from the study were presented at the American College of Gastroenterology 2020 Annual Scientific Meeting.

Let's get into the topic of double switching. For this study, you were able to evaluate both patients who were on reference infliximab [Remicade] and those who were on a biosimilar infliximab [Inflectra] who switched to biosimilar Renflexis. This enabled you to study switching from 2 sides. How has that been an advantage?

I think this double switching has been a very important issue that we wanted to look at because of the fact that each time a new molecule is introduced, there is a question of whether there is immunogenicity and whether there is any antibody formation. That is a very important question, especially for the future, when you may need to switch again or something else may happen. So, this was a unique feature [of the study]; we had a significant number of patients who underwent a double switch in a relatively short time period.

Mechanistically and at the molecular level, we wanted to see whether there was an increased risk of failure with a double switch versus a single switch, based on the fact that these are all protein molecules and they have the propensity to have some development of antibodies against them. That was an inherently important question for us to answer. We were able to look at that in this particular study because we had a relatively high number of patients who had a double switch versus a single switch. And we found that there was really not much of a difference.

We haven't done the full statistical analysis on it yet. There is no 

 value that we can show right now, but we have the initial results and we are expecting the manuscript to be out very soon. We are going to submit the manuscript for publication, and there will be more detail on this. But in the preliminary analysis, we did not find much of a difference between doing single or double switches.

The value of knowing how patients will or will not progress on a biosimilar and then on another biosimilar is important because the pricing might be different. In the private sector, for example, you might find it attractive as a clinician or a patient to switch to a cheaper form of a biosimilar. And you would want to know that if the patient has received one molecule or another, that switching will be OK.

Multiple studies have shown that there has been a delay in biologic usage. Perhaps one reason for the delay is the cost aspect. [Garbled].

So, hopefully, by showing that these cheaper drugs are safe to use, there can be greater utilization of them and more people on biologics, which has shown to have an impact on disease over the past 20 years of use. The best efficacy always occurs when you use [the drug] early in the disease. If you use it earlier, within the first few years of the disease, that is always much better. So, the aim is to, obviously, increase the utilization of these drugs and show that there can be some cost savings along with safety for the patient. Reduced cost may lead to better utilization of that drug.

CfB: Tell us about the continuation rate findings and the significance of these. Is the 83% continuation rate a very strong number?

Yes, 83%, I agree, is a very relatively strong number. A lot of these patients were stable when we started off. And that was a clinical question that we really wanted to answer. If you look at the NOR-SWITCH study, it was somewhere between 26% and 31%, but, again, those are people who started on therapy.

So, there are different numbers out there. It's not an exact science. And obviously, all the patients were not controlled. We looked at everybody. We did not look at a [group] based upon their [past medications]. Our criteria were that they had to be stable. It was not that they had 3 or 4 drugs before they were stable. There are multiple different parameters that can impact your stability.

But if you look at all data across the board, this compares very favorably: 83% or so were still on the drug at the end of a year. So, I think that is about the best data you will get by looking at this particular subgroup, which is chronic disease, which has its ups and downs and has a different avenue of disease course [than other conditions]. 

CfB: Can you discuss the reasons discontinuations occurred, and do you have any thoughts or conclusions that you drew from these data?

So, they're pretty spread out. People were spread out across the board: They developed antibodies, had a chemical relapse, had a hypersensitivity reaction, which was also small. Some developed cancer over that time period, which obviously can happen; they developed infection. Patients sometimes refused to continue treatment any further.

So, it was scattered, but nothing really stood out. We could see that there was not a particular reason for stopping treatment. There was a smattering of different reasons for discontinuation across the board, including infectious malignancies, lack of clinical response, which we expected. So, if you take out the lack of clinical responses, it was about 8% to 10% on that basis. It was a whole smattering of different reasons. There was no particular signal that emerged, when we looked at the reasons for discontinuation.

CfB: Do you think you could have performed the same study in a private clinic or a commercial insurance setting?

I don't think that would have had the same level of granular data. We had all the colonoscopy reports. We had the the follow ups and the clinical visits. We could look into each time they came into the clinic for an infusion. We looked at the factors that were recorded and all the individual notes.

It would be a very massive undertaking if, for example, 30 big institutions decided to get together, looked at all the records, and decided they wanted to do this kind of study. They could probably do that but that would require collaboration from multiple different investigators from multiple different institutions who could then collect all the data. So, the answer to your question is yes, but it's very cumbersome to do. It would require a lot of effort, as well as coordination, in order to achieve this, but it could be done.

CfB: What are the further implications from your findings for the medical community? What may people infer from this study that we haven’t already talked about that might be of value for treating patients in this setting?

What we have seen is that—and again, this is one of many other studies, just to put that into context—we are getting more data on switching. The amount of money that is available in health care is limited. I think we all have to look at that aspect. But if there is a drug, the most important thing is that it should be safe and effective, and that is what we're looking at. If there is a drug that is safe, effective, and a lot cheaper, then we should offer it as an alternative to our patients so that we can increase the utilization of this drug. Obviously, if it is much cheaper, then there's money to be saved. That's a call that should be made, saving health care money, but without compromising efficacy and safety.

That is why the VA has always been very patient centric, as well as physician centric. And that is why there's always a voluntary decision whether you want to make the change, or not. And what we're hopefully showing is that our aim is to help patients and physicians decide if they want to make the change or not. That is what the real-world data are about, to give some real-world experience so that patients and physicians can see what the data are, and that can help them make the decision one way or the other.

CfB: Just as a closing thought. The second study publicized by Samsung Bioepis noted a huge, 800-fold increase in the use of biosimilars in the VA. That's quite something. What might account for this level of confidence within the VA versus outside.

I'm not familiar with what the numbers are on the outside so, I can't really make a comparison. You have to look at what the starting point is and how many patients were on [the drug]. I don't think the VA is very different from the private sector, on that basis.

I just want to just clarify that the findings from the VA are generalizable to the private sector also. I want to make that very strong point. VA patients are very much the same as those in the private sector. In fact, they have a little bit greater access to care and medications because they don't have to pay anything for the medications. All of their infusions and everything else is free. So, that, I think, is one aspect. I've been in the VA for 10 years and I have never had [a problem] writing a prescription for a biologic or biosimilar infusion. I also worked in the private sector, and in the private sector, sometimes the insurance agencies will refuse to [approve] something. So, the VA is definitely not worse and maybe better than what it is in the private sector.

Nabeel Khan, MD, an associate professor of clinical medicine with the University of Pennsylvania, explains how a recent infliximab switching study builds support for use of biosimilars and early treatment with these agents. 

Part 2: Nabeel Khan, MD, Discusses the Significance of a VA Study on Biosimilar Switching

Here are the top 5 biosimilar articles for the week of November 2, 2020.

Number 5: Biosimilar orphan drugs might not be cheaper than innovator orphan products, owing to multiple factors, but 

 could change this, a presenter said at the Terrapinn Festival of Biologics Basel 2020.

Number 4:The American College of Rheumatology (ACR) has 

 in opposing a UnitedHealthcare (UHC) plan that could increase patient out-of-pocket costs.

 and other governmental entities can get more biosimilars into circulation, faster.

 could lead to new forms of pharmacodymamic measurement that improve speed and efficiency of biosimilar development and approval.

Number 1: The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials 

The Top 5 Biosimilar Articles for the Week of November 2

The Center for Biosimilars® (CfB): I’m Tony Hagen, senior editor with The Center for Biosimilars®. Today, we’re talking with Nabeel Khan, MD, an associate professor of clinical medicine with the University of Pennsylvania and an author of a retrospective, real-world study that demonstrated safety and efficacy for patients with inflammatory bowel disease [IBD]. They switched from reference infliximab to the biosimilar Renflexis, or from biosimilar Inflectra to Renflexis. The findings showed a high rate of continuation for patients on Renflexis. Findings from the study were presented at the American College of Gastroenterology 2020 Annual Scientific Meeting.

Switching patients with IBD is a difficult decision because you’re worried about the effects this might have on disease stability. Can you discuss these issues?

Sure. So, I think this is a relatively new area. So, that is one of the reasons why there is some apprehension, because it is relatively new and data oriented. The first big trial that was published was the NOR-SWITCH study, which looked at a very big cohort of patients with multiple different conditions, and the switch had to demonstrate a noninferiority of 15%, which was met.

Since then, there have been multiple different follow-ups on this [garbled]. So, there have been more biosimilars that have been introduced to test that. So, as time has passed and more data is coming out, it has become a little bit easier to switch patients on those products. Part of the aim of our study was also to show what the impact of switching was because a lot of the European data has shown that it is safe to switch.

So, we also wanted to look at that outside the trial basis—the NOR-SWITCH study was within the trial basis—so, we looked at it outside the trial basis to see what the impact was upon switching, and we found that it was quite safe to switch the patients, at least in our preliminary data. And we hope that with this there can be further utilization, within the states, of increased utilization of biosimilars, and all anti-TNF [tumor necrosis factor] drugs for that matter.

CfB: So, you've found that switching is safe, but what are the concerns among doctors and patients when they're presented with the idea of switching and the newness of biosimilars? What sorts of concerns come to their minds immediately?

So, I'm going to break it down [into multiple parts] One is the patients. The patients want to be stable on something and don't really want to switch. The inherent thing on that basis is that you're taking something away that someone is stable on. And as the old saying goes, if it isn't broken, why fix it? I mean [those that have switched] are stable. They're doing well.

Obviously, the biggest concern before switching is about the patient's stability and then, they're a little bit worried about whether a biosimilar will have the same effectiveness as the previous drug they were on. So, they are worried that the effectiveness of the drug may or may not be the same. Those are the questions they have. Then, they're also concerned about the side effect profile and whether they're going to get more side effects or whether they will get more of a drug reaction when they switch. Those are the predominantly major questions that do come up: efficacy and safety.

Physicians also have the same kinds of questions. They may not be comfortable with a patient being on [a biosimilar]. So, there's a reluctance to switch on that basis. And as long as [a patient] continues on [a reference product] and the patient is doing well, they think that there's not really much of a need to switch. And that is perfectly understandable. You have somebody who is doing well and is stable on [the reference product]. There's no harm in continuing them on that particular drug. And then, the other concern is what will happen to the immunogenicity, whether a patient will develop antibodies to the newer drug. And from that perspective, you may need to do multiple switches to see whether a patient will develop antibodies or not. So, those are the primary concerns. Again, efficacy and safety are the 2 basic issues that you will be looking at.

Also, what are the long-term consequences of it. This is a third concern that comes up because the data have all been relatively short term, so far. We don't know what happens in the long term. Anti-TNFs have been around for about 20 years and reference infliximab was introduced in 2000. In 20 years, there's been a good degree of data and there's a greater degree of, let us say, patient awareness. So, like with all new things, it does take some time, but in the end, our aim is to show what is the effect and what is the impact of the new change. We're not recommending whether one product or the other is better. We're just looking at what is the impact of the change and whether this is a viable thing to do or not.

CfB: These diseases are very upsetting to patients in terms of the symptoms that they develop, and this causes a great deal of anxiety, as well, for patients when presented with a possible treatment change or switch to a biosimilar?

It’s not a treatment change, so let's first discuss that. Generic drugs have been around for ages. The whole concept of switching from the original to the generic is not a new concept. That concept has been around for a while. The newer concept is that you're getting a biologic agent and now you're switching from originator to a generic biological agent. And because of the fact that these diseases, like you correctly mentioned, have a lot of potential to be, clinically, very debilitating and have long-term complications, patients are very concerned about that.

So, obviously patients are concerned about that and those are very valid concerns. And all educated patients have an idea of what exactly is going on, but this happens with every medical condition. Whenever you change an originator drug to a generic drug, people have questions about efficacy and safety. I think that can be extrapolated to patients with ulcerative colitis or Crohn disease, more so because they can have pretty significant clinical manifestations as well as long-term complications.

CfB: These issues are said to be a chief part of the resistance to using biosimilars. The VA has proven to be a good place to try a switching study. What is it about the structure of biosimilar use policies or formulary policies that has facilitated a study like the one you have done?

The facilitation of this in the VA was not based so much on policy but on the VA's centralized pharmacy benefit management system. So, if you want to do a study, you have these 9 million veterans who fall within the VA health care system. You have a record of all the medications that they're on and you have long-term longitudinal follow up. So, if you were to try to do a study in the private sector, it would be difficult because you are pulling information around from here and there.

Now, the other thing is that you can individually look at all the records to see what happened to the patient because there is so much research that is done in the VA. The VA's record system is so comprehensive, and it is shared nationally. Like I can look at a record of somebody who lives in California to see how he did after the switch was made.

Now, obviously you cannot do this within the private sector health care system because you can't access somebody in a capital health care system. [For example,] we cannot look at Kaiser Permanente's health care system and see what happened to those patients individually after switching. You may have some official medical records data on that, but they are not very granular, where you can go into every individual patient's chart and really see what exactly is happening to them.

So, that is why the VA is very good for doing this kind of research, because of the fact that you have all this data that is recorded. Especially with infusions, patients have to come in and get those infusions. So, you know exactly what is happening to those patients because they’re coming in every 8 weeks, or 6 weeks, or whatever regimen they're on. And then, you can see the impact of the change on that. So, you could probably see these kinds of things outside of the VA, but because of the way the electronic medical record system is set up and the commitment to develop this electronic medical record system for researchers to evaluate what is happening across the nation, it's easier to look at this within the VA.

CfB: Records are very important for your study, but so are policies that encourage doctors to use biosimilars. Could you have done a study like this on the private side or not?

So, let me clarify, it's not that they are encouraging all doctors to switch people. The VA is very open to letting the doctors do what they want to do. The availability and cost savings associated with biosimilars is pointed out to doctors. And if they feel their patient can be placed on that product, they can voluntarily do that. It's not something that we are forced to [do]—let me clarify that. There is no coercion in the VA. The VA does what is best for the patient and for the patient's care.

With every new drug that does come out, the VA will educate physicians that there is a new drug and that if they feel that this can be a safe substitute for their patients who are on another therapy, then they can switch them. If they feel it is not safe, then they don't have to do that. It is not that the VA is forcing every patient to automatically change over to this drug. It is a decision that is made literally between the physician and the patient. They decide whether they are going to go ahead and do that or not do that. And if both parties decide not to do that, there is no portion of the VA that says, "No, you have to do that."

Nabeel Khan, MD, an associate professor of clinical medicine with the University of Pennsylvania, discussed a study in which patients were switched from reference and biosimilar forms of infliximab to another biosimilar infliximab, Renflexis.

Part 1: Nabeel Khan, MD, Discusses an Infliximab Double-Switching Study 

Bhuvana Sagar, MD, the national medical executive at Cigna Health Care, discusses how Cigna has balanced using multiple biosimilars for 1 originator while also maintaining cost efficiency.

As more biosimilars enter the market, competition for market share overall helps to decrease the total cost of care; however, too many choices for a reference drug can create cost inefficiencies.

Sagar explained that in order to manage this, Cigna met with its large providers, including community oncologists and others, to gain feedback on current practice issues.

Knowing which drugs are on the market and which ones are gaining the most market share helps to lower the unit cost for prescriptions and ensures cost-efficiency for both patients and employers. Sagar said that working with providers is how Cigna makes sure that providers can accommodate their policies as easily as possible.

Bhuvana Sagar, MD, the national medical executive at Cigna Health Care, discusses the importance of maintaining cost efficiency when juggling multiple biosimilars for 1 originator in the practice setting.

Bhuvana Sagar, MD, Discusses Maintaining Cost Efficiency While Using Biosimilars

Here are the top 5 biosimilar articles for the week of October 26, 2020.

Number 5: Earnings fell overall for Biogen, although biosimilar revenues continued an 

 and were up 13% for the third quarter of 2020.

 discuss Amy Coney Barrett's Supreme Court seat and how that might affect deliberations on the Affordable Care Act and the Biologics Price Competition and Innovation Act (BPCIA)

Number 3: The strong growth of biosimilars Pfizer recently launched in the United States are part of the success story for the 

, although reference etanercept (Enbrel) sales have seen major erosion.

Number 2: Investigators from the University of Utah said they found no additional safety or clinical risks in a study of patients 

 from originator infliximab to infliximab biosimilars.

Number 1: Investigators derived a set of 

 for improving biosimilar use from 44 interviews with physicians, hospital pharmacists, nurses, patients (or their representatives), and regulators across Europe.

The Top 5 Biosimilar Articles for the Week of October 26

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences™ Medical World News, The Center for Biosimilars® is pleased to welcome Chad Pettit, executive director of Marketing and Global Biosimilars commercial lead for Amgen.

Follow-on products that have been developed and marketed by originator companies threaten to coopt a large chunk of business from biosimilars. What is your take on whether this is a healthy market activity vs depriving health care consumers of lower-cost care?

 I believe that innovation should be encouraged regardless of where it comes from. Innovation creates more treatment options for patients. It allows for competition across a class of medicines, and the more, the better. When you look at innovation in the class and then you look at biosimilars coming into the marketplace and creating competition, that's really good news for patients. It's really good news for the health care system, in terms of the cost savings that can be achieved via the sustainability it produces over the long term.

CfB: Although biosimilars are launching at lower WAC [wholesale acquisition price] and ASP [average sales price] to reference products, are we seeing sufficient biosimilar penetration in the marketplace? Why or why not?

 Yeah, we're seeing manufacturers launch [biosimilars] at WAC that is generally 15% to 37% lower than the reference product. And competition is also resulting in lower [ASP] for both the reference product and biosimilars, which leads to this additional savings. So, I would look at the cost savings that are resulting through competition on price, as well as the uptake that we're seeing with biosimilars. In totality, that creates significant cost savings for the system.

CfB: Can you compare the growth trajectories of filgrastim and infliximab biosimilars, and discuss why there's so much divergence between the two?

 So, if you look at supportive care, it's the most mature US [drug] category. The first biosimilar that came into the marketplace was a biosimilar filgrastim [Zarxio]. And I think there's really good insights in terms of how biosimilars and the reference products change over time and gain share over a period of time, and in that case, gaining over 70% market share over 5 years. If you look at inflammation, 3 of the top 6 best-selling biologics are anti-inflammatories.

So, it's an important question in terms of infliximab, which is the third best-selling anti-inflammatory. We believe that the competition in that marketplace will lead to significant cost savings. And if you look at the bigger picture and compare the cost savings that Europe has seen with infliximab versus the cost savings that the United States has seen with infliximab so far, the totality of cost savings in the United States actually exceeds the totality of savings in Europe. And so, I would say that we're on track. Every class is going to have different levels of uptake. But overall, we're really seeing a marketplace that is taking off.

CfB: Can you discuss one or two reference products for which ongoing biosimilar competition is likely to be impressive in the coming years?

 Well, we've just launched 2 biosimilar oncology therapeutics, and the story's not over on those. And that's really starting to play out, and we've been very pleased to see commercial payers put the tools in place that they have and our ability to compete in the marketplace. We've seen really good market share for those products. Of course, the big one that's coming is adalimumab. That's exciting. It's the number 1 selling biologic in the marketplace and Amgen has a biosimilar adalimumab. We're excited about that marketplace.

CfB: How widespread is this trend of health plans and PBMs [pharmacy benefit managers], replacing reference products with biosimilars on formulary or making biosimilars preferred? Do you have confidence that this will continue?

 US commercial insurers have all the tools that they need to support the adoption of biosimilars. And that ranges from formulary management to value-based programs. Today, we've seen significant savings to Medicare and commercial payers, as prices have declined for both. We're seeing very good uptake rates. And I would just say that all of this together demonstrates that the marketplace is receptive to biosimilars and that stakeholders have confidence that the payers, as well as the providers, are very open to a biosimilar that comes in and competes. That's what we want to see. Our belief is, in terms of US policymakers, the best thing that we can do with biosimilars to achieve long-term cost savings is to nurture a sustainable marketplace with biosimilars by creating effective policies that allow for head-to-head competition between the innovator biologic and biosimilars.

CfB: What more is needed on the payer side to increase access?

 The payers really have all the tools that they need. If anything, what's needed is continued education–education that is scientifically accurate and creates the confidence that providers and patients need to adopt biosimilars.

CfB: And lastly, what will be the future key drivers of biosimilar uptake? Will the 2019 Senate bill (The Prescription Drug Pricing Reduction Act) have a substantial impact?

 If you look at the big picture of the US health care system, what we need in the long term is a sustainable marketplace. We need a marketplace that creates a foundation that includes intellectual property, to allow for the risk and the investment in innovative medicine. It's that burden of the disease that's really the cost in the health-care system. And then, [we also need to] create a level playing field and have appropriate regulatory standards that allow for investment in biosimilars, which creates cost savings that allow for sustainability in the long term.

Amgen made a decision in 2010 to invest in and to develop a portfolio of biosimilars, and if we look back, it was really just the right thing to do. As we stand here in 2020, facing a global pandemic that's putting tremendous pressure on patients, policymakers, hospitals, and physicians, in terms of financial burden, here we are with this really strong portfolio of biosimilars and a broader marketplace of competitors who come into the marketplace. Our belief is that we can bring reliably supplied high quality biosimilars and help alleviate some of this financial burden that that we're all facing. So, we're very optimistic and I believe that there's a tremendous amount of hope that biosimilars provide now, in the immediate term with the pandemic that we're facing, but also as we look into the future.

CfB: To learn more, visit our website at centerforbiosimilars.com. I'm Matthew Gavidia. Thanks for joining us.

Chad Pettit, executive director of marketing and team leader for global biosimilar launches at Amgen, discusses the potential for a level playing field for biosimilars and reference products.

Part 2: Chad Pettit on “Head-to-Head” Biologics Competition

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life SciencesTM Medical World News, The Center for Biosimilars® is pleased to welcome Chad Pettit, MBA, executive director of Marketing and Global Biosimilars commercial lead for Amgen. Great to have you on.

For our first question, there have been 2 biosimilars approved all year in 2020. Some feel this is a slow pace. Why is Amgen so upbeat about the rate of biosimilar entry?

Yeah, that's a great question, Matthew, and thank you for taking time [to speak with me]. Just as a little background. Amgen has been developing biologic medicines for 40 years and we understand innovative medicine. We've invested in biosimilars. We've got a portfolio of 10 biosimilars that we're launching, with a total investment of about $2 billion. So, we're very optimistic about the biosimilars marketplace and the direction it’s going.

If you look at this point in time, which I think is really where your question’s getting to, it's really a time of remarkable change. Today, we've got 18 FDA-approved biosimilars on the market. There are more on the way. Last year was a really incredible year. We saw a 65% jump in the number of approved biosimilars and 157% increase in the number of biosimilars that are available on the market. So, when we look at this year, we really believe that the US marketplace is really poised to welcome new biosimilars in 2020 and beyond for years to come. And the competition that results from that will result in significant cost savings for the health care system.

CfB: Now for something you just alluded to, Amgen has biosimilars in the market, as well as originators, that face competition. Would Amgen's report be less positive about the market structure if [Amgen’s own] reference products weren't holding up so well against competition?

The report was developed as part of Amgen's commitment to staying at the forefront of biosimilar education. And it reveals the mechanisms that support the long-term success and the sustainability of the marketplace with biosimilars. And if you look at the big picture of what comes out from this data, the US marketplace is really well established and accelerating across the key therapeutic areas, which then creates this cost savings, and additional treatment options for physicians and patients.

Like I said, Amgen has been a pioneer in biotechnology for 40 years. We have innovative medicine, which is critical to treating major diseases across patients, and we have biosimilars, which create a competition that allows for cost savings. And so, I think if anything, Amgen is actually more credible because we look at the biologics marketplace in its totality.

CfB: Can you explain how CMS' new HCPCS [Healthcare Common Procedure Coding System] codes for biosimilars have supported improved uptake and better savings?

Yeah, that's a good question, and I think it's a bit of a technical question. I would say, and if you look at the report, we actually highlight that assigning a unique HCPCS code for each biosimilar can help promote a robust and competitive marketplace. And it really does it in 3 ways. One is having unique or separate HCPCS codes, creating a foundation for innovation by supporting a sustainable marketplace over the long term.

Secondly, because it creates a sustainable marketplace, it lowers the risks that are associated with developing and marketing these complex products that are biosimilars. And so, it allows biosimilar manufacturers like Amgen to invest with confidence in medicines that are going to compete in the medical benefit side of the US business

The third thing it does is create a level playing field for both the reference products and the biosimilars. And one of the ways it does that is by reducing some of the concerns and confusion around traceability, which shared HCPCS codes would create.

CfB: When the Amgen report talks about overall market share for biosimilars, is that CMS and private payer coverage taken together?

Yes. It looks at the totality of the market. The reality is, when you look at the market at that level, every product is going to be different in terms of the proportion of patients who are on Medicare, typically 65 and older, vs those who are receiving coverage through their employer through private coverage. So, there are going to be differences between products.

What I could comment on in terms of market share, in totality, is that if you look at the biosimilars that have launched, many of them have gained significant share for the therapeutic area where they were introduced. As an example, the short-acting granulocyte colony stimulating factors (GCSFs) have achieved more than 70% share in 5 years, and the long-acting GCSFs have achieved 20% share in the first 12 months that they were on the market.

Another example that's important for Amgen is that we just launched 2 oncology therapeutic biosimilars in the United States. And in the first year, we've achieved nearly 40% share and then 30%, respectively, for these 2 products. And in doing so, at list prices that were 15% lower than the reference product and our average selling price was 12% lower than the reference product, which creates savings for both Medicare and commercial payers.

CfB: Some think that CMS has done better at incentivizing biosimilar use than private payers. Do you agree or disagree with this statement?

You know, I think the one thing that CMS has done that I think has been really important is that it's laid a foundation for success with separate payment codes.

And what that does is it allows the reference product and the biosimilar products to compete on a level playing field. And because of that, when we look at competition, both in Medicare and with commercial payers, we're seeing really good success. Commercial payers have all the tools they need to support biosimilar competition and uptake and Medicare has created this level playing field and the results really speak for themselves.

Like I said, we had our 2 oncology therapeutic biosimilars secure nearly 40% and 30% of the market share, respectively, in their first year, which is great. That's fantastic. Then, if you look at other products across biosimilars, they're also achieving very strong uptake, which is a reflection of competition. And if you look at the benefits of competition, as competition has grown, we've seen prices fall.

For example, there was a recent Bernstein analysis that suggested that biosimilars are driving a consistent drop in average sales price between 10% to 15%. And if you look at products that have been on the market longer, so let's say up to 5 years, we're seeing a 40% to 50% decline in average sales price, and that's reflected in the trend report. I think this is really a good example of how the marketplace is not only working with biosimilar competition, but really taking off.

CfB: Many feel that biosimilars in the United States have been a failure because payment systems, such as rebates for originator drugs and PBM [pharmacy benefit manager] deals, make it difficult for biosimilars to get a foothold. What's your take on this?

Well, I think the proof is in the pudding here. If you look at the marketplace itself, we're seeing really robust marketplaces across many different sets of products. And, like I said, we're seeing an average sales price decline of 20% to 40% for products that have been on the market for 2 years, but 40% to 50% for products that have been on the market for more than 5 years. If we look at just the bevacizumab marketplace, in just the 1 year that we've had [a product] on the market, there has been a 10% decline in the average sales price.

This is a good example of how the marketplace is receptive to biosimilars and [how] stakeholder confidence, which includes payers as well as health systems and providers, is encouraging proper use.

CfB: And to build on what you just said, although we're seeing biosimilar prices declining, why aren't we seeing a commensurate reduction in reference product prices? Can we expect to see similar reduction in reference prices?

Yeah, if you look at the trend report, it does a good job reflecting the decline in reference product prices and, overall, what that means is that when you see reference product prices coming down, biosimilars launching at lower prices, and competing on price. That's the mark of a healthy marketplace and a system that's working. And that's the foundation for a longer-term, sustainable marketplace with biosimilars that ensures future investment, both for reference product manufacturers and for biosimilar manufacturers. That's something that at Amgen, since we manufacture both, is really important for us. We believe that's the way to achieve success, by creating lifesaving medicines and cost savings in the health care system.

Chad Pettit, MBA, executive director of marketing and team leader for global biosimilar launches at Amgen, discussed Amgen’s recent report on the state of the US biosimilars marketplace. 

Part 1: Chad Pettit on Amgen’s Assessment of the US Biosimilar Marketplace 

Here are the top 5 biosimilar articles for the week of October 19, 2020.

 with The Center for Biosimilars®, Neuclone’s company strategic analyst, Thomas Wakim, said that the groundwork for its projected programmed death-1 (PD-1) inhibiting biosimilars for Keytruda (pembrolizumab) and Opdivo (nivolumab) are well underway.

Number 4:Alexion receives positive regulatory news in its bid to 

 of biosimilar competition, and Celltrion Group announces a phase 3 trial for its coronavirus disease 2019 (COVID-19) prophylactic drug candidate.

Number 3: Biosimilar competition for Roche added up to a $3.83 billion 

 in the first 9 months of 2020, contributing to a sales decline of 4% in the United States for the pharmaceutical giant.

Number 2: Before its acquisition this year, Dean Foods attempted a 

 that led to a cost savings of $174,600 (77% reduction) by switching employees on a select number of originator specialty drugs to biosimilars.

 goes into detail on how biosimilars have become more numerous in their first 5 years on the US market than biosimilars were in Europe in their first half decade.