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 September 21, 2020.

 have been approved for Merck’s Brenzys etanercept biosimilar by Health Canada to include plaque psoriasis, psoriatic arthritis, and juvenile idiopathic arthritis.

Number 4: After receiving positive results from a phase 1 trial for its coronavirus disease 2019 (COVID-19) monoclonal antibody treatment (CT-P59), Celltrion Healthcare has received approval to initiate a 

Number 3: The American College of Physicians (ACP) said many 

to install appropriate checks and balances in the biologic drugs marketplace.

 were presented for PrestigePharma’s trastuzumab biosimilar candidate, at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Number 1: Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, 


To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of September 21

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life Sciences®' Medical World News, The Center for Biosimilars® is pleased to welcome Hillel P. Cohen, PhD, executive director of Scientific Affairs for Sandoz. Can you introduce yourself and tell us a little bit about your work?

I'm Hillel Cohen, executive director of scientific affairs at Sandoz Biopharma. I've been working in the area of biosimilars since 2003. I help explain the concepts of biosimilars to various stakeholders—with patient groups, health authorities, and within my own company. I also work with other companies, and I work with trade associations. For the Biosimilars Forum, I'm the co-chair of the education committee, and I'm also active in the education committee of the Biosimilars Council, a division of AAM [Association for Accessible Medicines].

So, I'm heavily involved with education topics. I've also discussed [biosimilars] and published in the areas of education, safety, interchangeability, naming, and other topics related to biosimilars. 

CfB: Can you briefly describe the Biosimilars Forum for our audience?

Sure, of course. The Biosimilars Forum is a nonprofit organization whose mission is to promote biosimilars-related education and policy advancement in the United States with the intent of expanding access and availability of biological medicines and improving health care. We are committed to ensuring the patients and prescribers have complete, truthful, and nonmisleading information about biosimilars.

CfB: What are the issues with biosimilar label descriptions as you see them? Is it not clear enough that biosimilars are as safe and effective as reference products?

First, let me say we appreciate that the FDA is working on this 

, and we look forward to working with the FDA as it evaluates its findings. We believe patients and health care providers need to be able to better understand the basic principles of biosimilars. In our comment letter, we urged the FDA to prioritize education about how biosimilars are as safe and effective as their originator products. Also, the FDA’s rigorous biosimilar approval process and high-quality standards should be emphasized.

We think patients should be aware that biosimilars have been available and a benefit to patients for many years. Currently, biosimilar labels identify the product as a biosimilar and they correctly rely on the data of the reference medicines' established efficacy and safety profile. The biosimilar development program is not designed to reestablish the already proven efficacy and safety.

CfB: Is the currently permitted label promotional material language too negative and why?

The currently permitted promotional language for biosimilars does not contain mandatory disclosure statements because there are no safety or efficacy concerns about biosimilars that need to be disclosed. The efficacy and safety profile of the biosimilar matches that of the reference medicine. If the FDA decides to include disclosure language, it will be critical to explain things in a positive and easy to understand manner so as to avoid negative perceptions. The Forum has learned that even factual statements can be framed negatively.

CfB: Also, what effect is that having in the provider community in terms of uptake of biosimilars?

At present, biosimilar use is relatively limited the United States for several reasons. One of which is the fact that they're not well understood by many health care professionals and patients. It's not the only reason but it is one of the major reasons.

In our opinion, the current practice of promotional materials not having disclosure statements is neutral. The addition of mandatory disclosure statements could be either positive or negative, depending on the tone and the content of the statement.

CfB: As part of its study, the FDA will examine perceptions with regard to similarity source and dosage administration of biosimilars. Can you explain why getting this wording right is essential to proper public perception?

In regard to similarity, we want to make sure that patients and physicians know that biosimilars are as safe and effective as their reference medicine. We think it's important to make clear that the FDA has the same quality expectations for biosimilars as the ones that are applied to reference medicines and that the FDA review criteria are very high. The Forum believes that messages about source, dose, and administration should be avoided because they are unclear or are of minimal value.

The Forum believes that the source of biosimilars and the reference products are not facts that need to be disclosed in promotional materials. Both biosimilars and their reference medicines are manufactured by the use of biotechnology. The fact that a reference medicine was manufactured by use of biotechnology has never been of concern. So, it should be irrelevant for biosimilars.

And by definition, the dosage and administration must be identical for both the biosimilar and the reference product. So, as a result, this information has very limited value for patients who have not previously received the reference medicine. And patients who just switched to biosimilars from the reference medicines will not see a change in these parameters.

CfB: What are the shortcomings of this study as the Biosimilar Forum sees it?

The FDA's request for comments shows that the agency is working hard to make sure the study is comprehensive. But first and foremost, it is not certain that disclosure statements are even necessary. The very fact that disclosure statements are added can add a negative message.

Moving forward, positive messages and positive tones should be used if there are to be disclosure statements. We have learned that even factual statements can be framed negatively, leading to a negative perception. It is very important that these negative perceptions and biases don't get introduced into the study. If used, disclosure statements should be relevant, avoid vague or overly complex topics, and avoid regulatory or health care professional jargon. Also, a sunset provision is needed after a set period of time, such as 3 years, to assess whether or not disclosure statements are still needed.

CfB: How can a study, like the FDA proposes, contribute to improvement of consumer and HCP [health care provider] perception of biosimilars and uptake?

Now, it is not clear that disclosure statements are even needed. However, if disclosure statements are included, there's an opportunity to improve education about how biosimilars are as safe and effective as their reference medicines, that the FDA has a rigorous biosimilar approval process, that biosimilars are held to high quality standards, and that patients have been benefiting from use of biosimilars for many years.

CfB: What type of language would you specifically like to see incorporated into package label descriptions? And would this language satisfy the need for clinical objectivity and clarity?

The Forum recommends 3 specific positive messages to be included in disclosure statements should the FDA decide that disclosure statements are needed. First, patients can expect that biosimilars will provide the same safety and effectiveness as the reference medicine. Second, the FDA has a rigorous review and approval process applying the same high-quality standards to both biosimilars and reference medicines. Third, patients have been benefiting from the use of biosimilars for many years.

CfB: And do you have any other thoughts on this FDA study?

The Forum's comments on the FDA's notice are intended to help enhance the quality, utility, and clarity of the information collected in the FDA study by [providing information on] what topics were covered [in the study], the tone of disclosure statements, avoiding vague or overly complex messages, and establishing sunset provisions for disclosure statements. When biosimilar use is limited in health care systems, patients lose access to safe and effective lower-cost treatment options and the health care system loses billions in potential savings.

CfB: Can you describe the current playing field for biosimilars and your concerns about unfairness, language use, and anti-competitive practices in promotions?

Forum companies and stakeholders have encountered disparagement and misinformation about biosimilars that have, at a minimum, caused confusion and likely contributed to slower uptake of some biosimilars.

CfB: What more could the FDA or FTC [Federal Trade Commission]do to give biosimilars the chance that they deserve to achieve greater uptake in this country?

 and joint statement announcing that they were collaborating to dispel misinformation and address anti-competitive behavior. As stated in our recent BioDrugs publication, the public should be encouraged to report examples of potential biosimilar disparagement and misinformation to the FDA and FTC. These bodies will then evaluate the report and take actions as appropriate.

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

Hillel Cohen, PhD, Education Committee co-chair for the Biosimilars Forum and executive director of Scientific Affairs for Sandoz, discussed whether disclosure statements are needed for biosimilar products and what they should contain, according to the biosimilar industry perspective.

Hillel Cohen, PhD, on How to Avoid Confusion in Biosimilar Promotions

Number 5: A few recent surveys suggest that physicians in the field of rheumatology would lean toward 

 over injections as a way to improve very high patient nonadherence rates.

 emerging on oncology biosimilars from Mylan, Samsung Bioepis, and Shanghai Henlius Biotechwill be presented at the European Society for Medical Oncology Virtual Congress 2020 this week .

Number 3: Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the 

 in biologics litigation that have emerged in recent months.

Number 2: With anti–tumor necrosis factor (TNF) therapy showing promise in treating coronavirus disease 2019 (COVID-19), authors called for these agents to have a 

Number 1: In the effort to find treatments for coronavirus disease 2019 (COVID-19) and related conditions, Celltrion Healthcare’s monoclonal antibody has shown promise in a 

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of September 14, 2020.

The Top 5 Biosimilar Articles for the Week of September 14

To watch part 1 of this interview, click 

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 Wayne Winegarden, PhD, a senior fellow in business and economics at the Pacific Research Institute (PRI), as well as director of PRI's Center for Medical Economics and Innovation.

Providers want freedom to use the same biosimilar each time rather than have to use a different one according to each payer and formulary. Do you see any workable solutions to this problem?

Yeah, absolutely. We're beginning to get into broader health insurance and health care reforms. That is an essential part of how we get to a better health care system, where the patient and the provider need to be in control of that patient's health. And to the extent that the provider is familiar with their patient, they understand what other medicines they're on and they understand the patient's unique circumstances. They're obviously much better positioned to know what the right medicine is and so, they absolutely need to be empowered. And the patient, on the flip side, should have that control because it's their health.

Again, this is getting slightly away from specific biosimilar changes and the interchanges of how we fundamentally improve how our health care system is operating from that patient-centered and provider-centric health care model, which is absolutely incredibly important in terms of broader health care reforms.

CfB: Are there other reforms in the payer paradigm that you think might be workable?

There are. We talked about shared savings, fail first therapies, separate biosimilar tiers, and ASP [average sales price] reform so that you have the same percentage dollar markup across a biologic in a biosimilar. All of these types of reforms, again, [represent] the idea being that you're not disincentivizing or disadvantaging one product over the other.

Along those lines, right now, we have a lot of tie-ins and sales. Those can be anticompetitive, and those should be changed. So, what we really need is a more efficient, less obstructed market so that the competitive pressures can come into play. We already see in the generics market that drug competition is a very effective means for driving down price and improving quality of care and improving adherence, which improves health outcomes. That same process can be leveraged for the biologics market. All of those reforms that we're talking about need to work toward that specific goal.

CfB: You talk about regulatory inefficiencies. Can you discuss broadening the applicability of the interchangeable designation?

Interchangeability is one of those complex issues. And a really interesting issue in terms of biologics when we're talking about interchangeability is that normally it refers to a pharmacist, and typically it's much more relevant for the small molecule drugs. Does a pharmacist have the ability to change a patient from a reference product to a generic product without going back to the physician? You need the interchangeability designation to make that work.

Often when we're talking about a biologic, it's being administered in a clinical setting. Well, in a clinical setting when the doctor is administering it, the doctor can prescribe the medicine that they believe is most appropriate for that patient. So, the interchangeability designation for the most part is not relevant. The provider, the doctor, or whoever is administering the medicine should have the right to use the medicine they feel is best for that patient, taking into account differences in costs. You have just as efficacious medicines, like a biosimilar to the originator, but one's cheaper.

There are clear advantages to the doctor having the ability to do that. And if interchangeability issues are creating confusion or hesitancy about that, they become a regulatory obstruction. So, to the extent that those issues are impacting our use of biosimilars, that is a very troubling regulatory policy

CfB: Semglee, an insulin glargine, was approved as a 505(b)(2) application and deemed to be approved under the BPCIA [Biologics Price Competition and Innovation Act]. [Semglee is therefore not technically a biosimilar]. Biocon Biologics has to apply separately to get a biosimilar and an interchangeable designation. What are your thoughts on this?

Again, we need that clear pathway. And to the extent that we don't have that, that is problematic. One of the things about insulin is that a lot of the affordability issues from insulin are actually coming from how we price drugs systemically, that gross-to-net bubble, where the patient's costs are based on that gross price, or the list price, which has been rising, but, actually, net costs have been going down. So, that's a very important concern when we talk about insulin—fixing that problem so that, in effect, we're improving patient affordability to actually reflect the market trends, not this inflated bubble. But with respect to the biosimilar versions, there are those complexities. I believe we're getting closer to getting that resolved. The quicker we can do that, the better. Again, more competition is always better than less. So, we are making progress in terms of that with some of the changes being implemented. That is certainly favorable. Could it be more efficient? Absolutely and we need to push toward that.

CfB: President Trump has proposed to create foreign drug buying pathways for Americans so they can have access to cheaper drugs, particularly insulin. What's your take on this as it relates to Canada?

It's a terrible idea. It's a terrible idea in relation to Canada, the [United Kingdom], and Europe. It is a bad idea for a number of reasons. First, let's think about Canada and let's think about the practical issues. There's 300 million Americans and there's 37 million Canadians. It's not possible for Canada to be the drugstore for the United States. [This policy would not] address our drug affordability issues.

I think, more importantly, you have access issues in Canada. They have access to about 50% of the medicines that have come out over the last decade and a half or so. We have access to nearly 90% of those medicines, which, by the way, means that if you have drug importation on that 50% of medicines that aren't available, you don't have drug importation. You can't import something that's not available. There are those problems as well.

But you're not importing all of those problems to the extent that you can get [drugs] into the United States; you're just taking the Canadian price controls. If you think price controls are the way to lower costs here, and [they’re] not, we should have the courage to have that debate and do it here or not do it here. The problem with price controls is that you decrease the amount of innovation. So, you harm patients in the future, and you decrease access. All of the problems that you've seen in these other countries, you would import into the United States.

I think, more importantly, there are ways to address drug affordability in the United States that maintain that balance that we get right. We do this better than other countries. We promote affordability and innovation. Look at the small molecule markets: 90% of small molecule drugs purchased over the pharmacy counter are generics. Most of those, about 95%, are going to cost the patient $20 or less. So, we have affordable drugs and we have continued innovation because you have the incentive to cover the $2.6 billion to $2.9 billion it costs to develop a new a new drug or a new biologic. We have that balance struck well on the small molecule side.

With respect to biologics, there are issues we have to talk about, such as biosimilar competition. We have to address the pricing issue in terms of the gross-to-net bubble, where we have an incentive for gross prices to overinflate. It [affects] the competition. You really want competition on the net prices in the market price. That would drive down the cost for the patients, but it would keep the systemic costs where they are. I don't think most people realize that if you look at the growth in net prices over the last 5 to 10 years, it’s actually less than overall medical care inflation. So, the problem is that the drug pricing system that we have is shifting too much of the cost to patients, and that's what needs to be addressed.

I go into that tangent because that's a much more effective way to create drug affordability here in the United States without bringing in all the problems that we would through drug importation, or bringing in price controls. And we haven't even gotten into the issue of counterfeit drugs.

If you open up the US drug markets to importation, you also open exposures to this problem [of counterfeit drugs], which is already a large problem. [Some] 10% of drugs on the market are counterfeit drugs. These are medicines that [may contain] a yellow highway paint, gypsum. Sometimes they'll have a drug that's not supposed to be there or that you could be allergic to. Again, we're opening up the drug supply chain to greater infiltration by counterfeits, and that's dangerous to patients. For all of those reasons, importation just makes no sense.

CfB: British Columbia has noticed significant savings on its mandatory switching since May 2019, and they've been able to plow substantial savings back into health care to improve access. Are there any lessons here that we can learn from?

I think the lessons are biosimilars create systemic savings. These are medicines that are just as efficacious [as reference products] and can lower overall spending. We don't need mandates. Again, this is something that providers need to be in control of along with the patient in that patient-centered proposal. But again, if you have a medicine that's just as efficacious [as the reference product], but is much cheaper, why wouldn't you use it where it's appropriate. And so, I think it demonstrates the real savings that we can generate here by just creating a more competitive market, not to go down that mandating route, but to remove the obstacles that are inhibiting a much more advanced competitive market here in the United States.

CfB: Can you discuss any current biosimilar legislation that you find promising or noteworthy?

What I'm most excited about, more than legislation, is the actual market dynamics that we're seeing. And I think that the growth in share that's occurring in the biosimilars market has been very encouraging. And we're beginning to see that market stand up. We're beginning to see the [effects of] education. People are recognizing the potential savings that biosimilars can offer and how they actually are just as efficacious as the originator product. As that continues to grow and as more companies continue to insist on favorable tiers for biosimilars and favorable terms, it could be very exciting for the future.

CfB: And lastly, as the FDA is busy with COVID-19–related issues, how is that affecting the pace of biosimilar approvals? And does the FDA have the resources it needs to do the job?

All hands being on deck on COVID-19 has consequences. It has consequences across the board. You see that in clinical trials. And so, obviously, the faster we can overcome that, the better. But there are undoubtedly consequences because everything requires resources and there's just a finite amount of resources. Things are still progressing across the board. We're still seeing progress outside of the COVID-19 area, including innovation with drug approvals. All of those haven't come to a complete standstill; but, undoubtedly, the focus, and rightly so, is on addressing COVID-19. So, it is the right thing to do, but as with so many things in the economy and society right now, COVID-19 is front and center.

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

Wayne Winegarden, PhD, senior fellow in business and economics at the Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation, discussed why importing drugs may not lower costs and what we can learn from Canada’s biosimilar programs.

Part 2: Wayne Winegarden, PhD, on What Canada Can Teach the United States About Biosimilars

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 Wayne Winegarden, PhD, a senior fellow in business and economics at the Pacific Research Institute (PRI), as well as director of PRI's Center for Medical Economics and Innovation. Can you just introduce yourself and tell us a little bit about your work?

 Oh, absolutely. Good morning or good afternoon, everyone. My name is Wayne Winegarden. As Matthew just said, I'm a senior fellow and director for Center for Medical Economics and Innovation at the Pacific Research Institute. Part of what we try to pursue at PRI, with respect to our health care research, is discuss how free market reforms can improve both the quality of care as well as reduce the cost of care. So, basically, we want to get that productivity that we see in other parts of the economy working in the health care sector. And at the Center, one of the things we focus on particularly is pharmaceutical products and medical devices. Right now, there's a lot of attention and there's specific issues, like [those that concern] biosimilars, that are unique to the pharmaceutical market and that's what we tried to emphasize when we're doing our research at the Center.

To start us off, specialty drug prices continue to climb but has there been a slowdown in the rate of that climb and what might be causing this?

 Yes, especially in the spend. And a lot of that is that we're beginning to see biosimilar competition stand up. For a while we were having a very difficult time getting that foothold in the market. We're still not anywhere close to where we could be or should be. But we are beginning to see the biosimilar market stand out, and that's beginning to have an impact, and over time, hopefully, we'll see more of that.

What are your thoughts on the constant price increases of drugs like Lantus [insulin glargine]?

 For drugs like Lantus, or really, across the market, we're seeing prices rise when you don't have effective competition. But we need to be careful when we talk about prices rising, because the market is so complex. 

Often when we're looking at prices, what we're looking at is the wholesale acquisition costs, or the gross price, which isn't the price systemically. It is the price that the patients' costs are based on, and that's part of the issue with the drug affordability problem that we have, but it's not actually based on the systemic price.

So, there are really 2 things that we need to look at: One is why that price is going up because, especially in specialty drugs, prices are rising too quickly. But also, we need to be very careful when we talk about prices. Here, we're talking about the relevant market price, and often when we talk about drugs that's not what we're talking about.

What's your take on the strength of the biosimilar market in the United States? Are there examples of success and are we poised for greater uptake?

 Yes, and yes. The greatest example of success is Zarxio, which has a majority of the [filgrastim] market. But even the infliximab market, where we've seen the biosimilar competitors drive down the cost of the originator product [Remicade], from a consumer perspective, is a success. Obviously, that raises issues in terms of sustainability of competition, which we need to be very careful about, and we need policies that support long-term durable competition, which is a different issue altogether. 

We are definitely seeing some successes and we certainly are poised for more. I think the education about biosimilars is getting out there. People are recognizing them. And we also have some very important biosimilars in the pipeline that, hopefully, will be in the market soon. And they could make a very, very big difference in terms of the costs.

How about biosimilar uptake during COVID-19 [coronavirus disease 2019]? What do you think we're going to findwhen the dust settles?

 With COVID-19, obviously, the biggest issue in terms of public health in drug is going to be the vaccine. And so that's a little bit outside of the scope in terms of biosimilars. 

Especially because of all the stress that COVID has placed on the health care system, it actually accentuates the need to get [the biosimilar] market up and running and get a much larger [market] share. I mean if generics are 90% of the market for small molecules, we need to get close to that share with the biosimilars to help bring down the cost because of all the stresses COVID has put on [the industry].

Obviously, [COVID has put stress] across the economy, but it has targeted the health care system. And so, [biosimilars] could help promote greater affordability and improve people's health and, especially, adherence because when we have greater adherence, we have greater health outcomes. All of that is amplified because of the current environment that we're in. So, in that sense, it heightens the need for us to get this market up and running faster.

What are your thoughts on the power of large employers to shift their employees toward biosimilars such as Disney and Costco have done, and do you see this trend gaining significant momentum?

 I definitely see it gaining steam. We've seen it in the numbers that we've been tracking the amount of savings we're getting from biosimilars. In the latest numbers that we've run, we're up to $1.8 billion. That was from a few hundred million just a couple of years ago. So, we're seeing much greater usage, greater market share, and the savings are going up. Obviously, the potential is 10 times that, if not more. So, there's a lot more to be gained but we are seeing that [growth] and the power within the large employers. Absolutely. 

If we look at the way the health insurance markets are today, they're driven by the employers. Now, we can have a whole debate about whether that should or shouldn't be the case, but that is the reality today. And so, as large employers switch, you really have that double effect of one; they're moving a large population toward more-affordable drugs—that is a beneficial impact—but [you also have] the secondary impacts of news stories that come from it and the awareness that those drive other large, as well as smaller, payers towards embracing biosimilars. So, that kind of double impact--the good and the excellent and up—is very important. And so, absolutely, we are seeing a positive data trend. It's very meaningful. And hopefully we'll continue to see more of that.

Can you talk about “fail first” or step therapy as a means of getting biosimilars into play?

 Oh, absolutely. Fail first is actually working in reverse when it comes to the biologics market. If we go to the small molecule market, typically, if you fail first when using a generic then, you can get the [reference product]. But basically, you're encouraging the use of the lower-cost product first and then, move to the more expensive product. We have the exact reverse in biologics and that's not the way it should work. It should be that you fail first on the biosimilar and then, you move to the reference biologic. 

But there's also another issue, which is that if you're failing on the originator, the odds of the biosimilar and vice versa, if you fail on the biosimilar, there are a lot of issues regarding the efficacy for that individual patient. I try to stay away from medical issues that are outside of economics and outside of where my expertise is. But you need to also be careful from that angle, where you're not really giving the biosimilar a chance, because if the efficacy is not showing [for the originator], it's not [going to] show [for the biosimilar]. So, you have those concerns as well. One of the most important reforms we need to make to accelerate the use of biosimilars is to address that fail first issue.

Are there any potential strategies for getting payers to steer clear of rebate incentives and put lowest cost biosimilars on formulary?

 There are all sorts of strategies that can be done. One of the things I think is important is to create a separate formulary tier for biosimilars. And you can have certain types of criteria in terms of price discounts relative to originator price or anything you want to have in order to for a product to qualify for it. But in order to share the savings--and that's a big part of the solution is just the savings that the biosimilars offer—the patients, the payer, and practitioners have to benefit. And if we don't get everybody's incentives aligned to have the patient using the biosimilar, then something along that chain isn't going to work well. 

So, you want a separate formulary tier where the biosimilar has lower co-pays, coinsurance, costs to the patient, or you can have higher reimbursement rates for the provider, so they have the incentive to use it. The payer should be saving money. That should be an incentive. You can also give them incentives along the star ratings for Medicare. So, you can give them a boost in the Medicare market. We need to get all of these types of shared savings or shared benefit going so that the systemic benefit, which comes from a lower cost product, is shared by everyone and everyone has the incentive to save that money. They’re all incredibly important reforms that we need and would encourage greater biosimilar use. Obviously, any payer can adopt those changes among themselves, work with their PBM [pharmacy benefit manager] to make and demand those changes. Customers, especially the large customers including payers and employers, need to start demanding better service out of their PBMs to ensure that they're getting the pricing and the value they deserve.

Part 2 of this interview will be available Thursday, September 17

Wayne Winegarden, PhD, senior fellow in business and economics at the Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation, discussed where the biosimilar market is heading and how employers can incentivize biosimilar utilization.

Part 1: Wayne Winegarden, PhD, on How Employers Can Better Manage Their Formularies

Here are the top 5 biosimilar articles for the week of September 7, 2020.

Number 5: Authors of a report on Medicare spending trends said there’s more to 

 of insulin than instituting out-of-pocket (OOP) caps.

Number 4: A review of changes in business practices by PBMs states that apparent reforms have been undermined by 

 arrangements that have stalled placement of biosimilars on formulary and slowed uptake.

Number 3: Bio-Thera Solutions has begun a 

 for its proposed ustekinumab biosimilar (BAT2206), referencing Stelara, which is used in the treatment of plaque psoriasis and psoriatic arthritis.

interviewed several experts for their opinions on the current need for biosimilars and how companies are working to overcome barriers to uptake.

Number 1: Some European markets are more formidable than others with regard to complexity and getting biosimilars established, but there are 

, Jonathan Sweeting, head of Europe for Samsung Bioepis, explains.

The Top 5 Biosimilar Articles for the Week of September 7

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life Sciences' Medical World News, The Center for Biosimilars® is

pleased to welcome Brian Gifford, research director of the Integrated Benefits Institute [IBI].

You've stated that through misdiagnosis, employees may never get a shot at [antirheumatic] drugs and their conditions may lead them to long-term disability. What solutions might there be for this?

Well, never is a long time, but I think that delays in diagnosis potentially could end up putting people at a higher risk of going into the long-term disability system. Now, I would caveat all of that by saying I don't work in the area of clinical outcomes so, I'm not really sure what the solution for that would be in terms of how we get people better diagnoses. But I would advise that the goal is always to manage the condition better so that people can have their lives back, pain free, and free of mobility limitations.

But if one of the business goals is to keep people out of the long-term disability system, this is where we start to ask employers to think about how their formulary plan design complements return-to-work-from-disability leave policies. So, are you thinking about how you are going to communicate the availability of certain kinds of therapies to occupational nurses, for example, that you may hire or retain, to help employees stay on the job or get back to work from a disability leave?

It's really about integrating a larger strategy and not just taking things piecemeal based on cost. Although, of course, costs, or expense, if I want to be consistent with my terms, is always going to be expensive. Expenses are always going to be important to how employers think about their policies, but I would advise that, for the goals of keeping people on the job and keeping people performing at a high level, we're really looking for ways that they can have different benefits policies complement one another.

CfB: And not only misdiagnosis, but as you just alluded to, health plan designs such as excessive co-pay requirements may be causing nonadherence. Can you discuss this?

I can, but let me let me pull that apart a little bit. I would push back a little bit on the term "excessive co-payments" as, of course, causality is always really difficult to establish, but here's what we know about the relationship between co-pays and medication adherence. An IBI study found that if you were to raise a co-pay for rheumatoid therapies by $20, you [would] cut adherence by about a third. And so, does that mean that the co-pay is excessive?

Well, it seems to work against the goal of making sure that people with rheumatoid arthritis are really well managed. It may also cut against the goal of keeping people on the job. So, finding exactly the right co-pay amount, and it's not just co-pays but things such as deductible amounts that can help employers save money, by passing those costs on to the plan enrollees.

But they have to understand that they may be sacrificing other kinds of things. If it leads to this longer-term chain of causality, and people are not adherent to their medication, it's impacting their health, it requires them to take more time off of work either incidentally with sick days or with short-term disability and, hopefully not, but long-term disability leaves, which may be the first step toward leaving the labor force. Those are also costs, and employers cannot shift those costs to anyone else. They're always going to absorb the costs of ill health insofar as it impacts productivity.

CfB: Let's say perhaps co-pay requirements are the wrong way to control costs for rheumatoid arthritis. What's your opinion on this?

Well, again, I wouldn't say it's the wrong way to control costs, you can always control costs by passing them on to someone else, in this case, the patient. I would encourage employers to really think about the goals of what they're trying to do.

A CFO [chief financial officer] who participated in one of our panels years ago advised me that employers don't adopt benefits policies just to manage the expenses. They are trying to do something with those policies. They have some larger business goals or benefits goals, and I would just encourage employers to think of that as well. How would changing a co-pay, or how would increasing a deductible or, conversely, how would lowering a co-pay or lowering a deductible have an impact on people's ability to manage any chronic conditions they have and stay on the job and be productive?

CfB: Are biosimilars, such as infliximab, making much of a dent in these rheumatoid arthritis costs for employers and payers?

IBI hasn't really studied the issue of biosimilars compared to biologics. And again, I think that the value proposition is going to be there. Clearly, if a therapy is less expensive than an alternative and it gets widely adopted, and is just as effective, then you're going to see a drop in expenses. That's by design and that's by intent. Nobody's going to expect anything differently.

But, again, if we're talking about the longer-term costs, I think those demonstrations still need to be done. We still need to have more research showing that people who are taking biosimilars are not only as healthy and as functional as anyone else, but that their function is actually playing out and providing some value to employers because people are better able to stay on the job and they're able to work with less pain. They are able to contribute more and provide value in that way.

CfB: Besides co-pay requirements, other payer policies have an effect on employee access to effective care for rheumatoid arthritis. Can you discuss these?

There are all kinds of ways that employers and people who were helping them manage their formulary, for example, their pharmacy benefit managers, are really trying to ensure that people are getting the therapies that they need [rather than ones that don’t match their conditions].

So, prior authorizations for some kinds of drugs showing that it's medically necessary. That's an important step. That's certainly something that is between the provider and the patient. But you have to understand that if you have a prior authorization, it could take a little bit longer for people to receive their prescriptions. For example, step edits, requiring that people try and fail to respond to preferred drugs, and quantity limits are decisions that are going to be made between patients and their doctors. And I'm certainly not going to advise that we would change that process, but we at least have to understand that like co-pays and high deductibles, prior authorization, step edits, and limits on quantities do represent a barrier to getting people effective treatments, particularly new treatments.

CfB: If you had a checklist of things employers could do to reduce the cost of rheumatoid arthritis in the workforce, what would be on that list?

I'm going to stick with a broader term of costs, as opposed to simply medical and pharmacy expense. So, again, the cost reduction goal here is going to be this larger opportunity cost from loss productivity due to illness. This is really going to come back to ensuring that all of your different benefits are designed so that they complement one another so that, for example, your formulary is supporting people's ability to stay at work and return to work. And understanding how these 2 parts work together and, quite frankly, a lot of employers don't.

So, really, it's aligning this larger benefit strategy as opposed to saying that they're going to manage the pharmacy benefit in one silo, the health care benefit in another silo, the disability benefit in a third silo, and as many silos as we have for the different things that we're trying to accomplish

So, again, this is this is where the [IBI] actually got its original guiding principle. In fact, the name of the firm suggests that these strategies need to be integrated. And that's not just a data integration issue. That's a strategic integration and it's also trying to keep in mind that ultimately, all of these different things are going to be integrated at the patient level. What looks like silos to an employer are actually part and parcel with the way people go through their everyday lives.

CfB: Among employers that have taken these steps, what kind of results are you seeing?

I wish I could answer that question. I wish I could say that I knew of employers that are really taking this kind of exhaustive strategic approach to the issue of biosimilars, formulary plan design, chronic diseases such as rheumatoid arthritis, and disability and sick day absences. Just insofar as we're talking about rheumatoid arthritis and biosimilars, I'm not aware of employers who are really taking this view.

I think that employers have a good opportunity because the chronic conditions that they have focused on in the past such as back pain and mental health issues, are actually going to become the model for how we should deal with other chronic conditions, particularly those that are going to be treated with specialty pharmaceuticals.

So, when I say how have employers been doing in this case, I think that case study of somebody who's managing it really well is still out there. I know that they focus on expenses. But how they are looking at their formulary plan insofar as it affects these other outcomes, I think that key employer who is doing this well is still out there but as of yet I'm not aware of who that is.

CfB: And lastly, do you have any concluding thoughts?

I'm going to go back to IBI's guiding principles. IBI was founded 25 years ago as a way to get people to think outside of their benefits silos and start thinking about the health of the person insofar as that is a contributor to business success. So, my parting thoughts are going to be kind of my opening thoughts as well, which is, think about how all of your benefits fit together. Think about not just your health care benefits, but your disability benefits your paid leave benefits and think about how these can be designed in ways that complement one another, rather than being changed in a piecemeal fashion.

Brian Gifford, research director of the Integrated Benefits Institute (IBI), discussed how employers can improve treatment adherence for their employees with rheumatic conditions in order to keep them productive and on the job.

Part 2: Brian Gifford on How Treatment Adherence Can Help Employers Save

Hello, I'm Matthew Gavidia. Today on MJH Life Sciences' Medical World News, The Center for Biosimilars is pleased to welcome Brian Gifford, research director of the Integrated Benefits Institute [IBI].

Can you just introduce yourself and tell us a little bit about your work at [IBI]?

For those of you who don't know, we are a nonprofit research and educational association and we focus on workforce health and productivity. What that means is we're the hub of the network of people who are really looking for ways to invest properly and invest wisely in the health of their workforce, not because it's necessarily the right thing to do, although, of course, many businesses tell us that that's one of the reasons that they make investments in health, but because that there is a longer term business proposition to it, such as healthier employees, employees with well managed chronic conditions, which allows people who are going to be on the job more often to perform at a higher level. So, we're always looking for ways to show business leaders that there's an advantage to investments in healthy workers. We'll usually focus on sick day absences and short-term disability leaves, but also on things such as on-the-job performance.

CfB: Can you describe rheumatoid arthritis and how it affects employee wellness?

One of the things about rheumatoid arthritis is, for a lot of people who have it, it could have some of the same symptoms as osteoarthritis. For example, osteoarthritis causes wear and tear on a person's joints as they age. It's going to happen to a lot of people. There may be a genetic component, but usually it's really just old age where you get aching, tender, and stiff joints.

With rheumatoid arthritis, it's different because you can have a lot of the same symptoms, but the cause is a little bit different. So, it's when the immune system is actually attacking the lining of the joints for reasons that aren't really well understood. For example, you get inflammation pain and stiffness. People report fatigue not just in 1 joint or 2 joints, but in the same joint on both sides of the body. The cause is, again, not really well understood. We know that there are some comorbidities around smoking and obesity. Very importantly, this can happen to anybody or in a lot of stages of life. It can come on rapidly and it can be pretty hard to diagnose. It's like a lot of inflammatory diseases. Crohn disease, ulcerative colitis, lupus, and so on. There are tests for it, but it can really come down to a diagnosis based on a wide range of symptoms.

CfB: Statistically, rheumatoid arthritis affects a relatively small population of employees but the cost to employers and payers is disproportionately larger than for more common conditions. Can you explain this phenomenon?

Well, think of some of the conditions that we might compare it to. I already mentioned osteoarthritis but also musculoskeletal conditions like back pain. You're right that you're going to see those kinds of conditions show up a lot more often in a working population.

Where we start to see the high costs of rheumatoid arthritis is in 2 different ways. One is that if you look at a population of people with rheumatoid arthritis compared with people without rheumatoid arthritis and you do whatever statistical controls you need to do to account for comorbid conditions, this is where you start to see some of the medical costs go up and this is for all kinds of treatments. For example, one of the analyses we did showed that somebody with rheumatoid arthritis compared with somebody without rheumatoid arthritis is going to have $7500 more in health care and pharmacy spending than somebody without rheumatoid arthritis. If you do the same analysis for osteoarthritis, it's going to be about $4000 more. And for back pain, which afflicts a lot more people, it's going to be about $2400 more.

Overall, this is where we're really starting to see this high cost. I should probably be a little more careful of my terms. I'm talking about expenses. So, these are excess medical and pharmacy expenses. Cost is going to encompass a lot more things and that's what a lot of IBI's work is about. But just in terms of what the health care system usually thinks about spending for treatments, and what employers often think about, this is where we're going to see rheumatoid arthritis have relatively high expenses.

And here's where the costs are going to come in. A lot of people refer to these as indirect costs, but I would still say they're direct costs. If we look at sick days, the number of sick days that we can attribute to people with rheumatoid arthritis, in addition to what people without rheumatoid arthritis have, that's about $530 a year. So, it's about 2 and a half extra sick days that people are not at work and they're getting paid. That's an additional cost. I'm not really sure that that's high on the on the list of employers’ concerns.

Of course, one of the other things that we focus on in IBI are the longer-term productivity costs. And this is going to be primarily in short-term disability leaves from work. So, a lot of people have insurance policies paid for by their employer that say that if you need time off to recover from an illness, for example, or to undergo treatments for an illness, or if you're having a really extreme bout of symptoms, you can get paid about 60% of your wages and take the time off you need to recover.

What we find is that for [employees with] rheumatoid arthritis, compared with the [general working] population, we don't really see a lot of disability claims. To me, that's probably some evidence that all of that excess spending on treatments is actually working to keep people on the job. But when they do have to take time off from work [for rheumatoid arthritis vs] other kinds of conditions such as osteoarthritis, back pain, and other musculoskeletal conditions, this is where we start to see a really heavy burden in disability claims costs for rheumatoid arthritis.

So, yes, it's a small population, but it can be really expensive both in terms of health care spend but also in terms of productivity costs.

CfB: You described a hidden population of employees who may not be recognized as having rheumatoid arthritis and end up costing employers and payers as you just described. Can you explain what you meant by this?

So, think about the difficulties in diagnosing rheumatoid arthritis. It could take a lot of testing. It could take a lot of interactions with doctors. But that doesn't mean that people who are undergoing symptoms of rheumatoid arthritis are just going to work through the entire time that they're being diagnosed. They might take short term disability for some other cause. They might be diagnosed as [having] osteoarthritis. It might be diagnosed as just some other kind of pain, especially if the arthritis is occurring in the back—for example, ankylosing spondylitis. These are all kinds of things that people might be taking disability for.

We found that if you compare [disability claims] from the population of employees with rheumatoid arthritis [to those for the general working population], disability claims are only about 1% of that general population prevalence and, again, that could be a good thing. That could be attributable to having well-managed conditions. But it also could be that somewhere out in the rest of the population, there are people who are not getting the kinds of treatments [for rheumatoid arthritis] that they need. They're taking disability time off and the diagnosis that's being assigned to that disability leave is something else, such as generic back pain or generic joint pain.

So, employers who are really trying to get a handle on what's going on in their population and what's going on in their short-term disability system, they might not see rheumatoid arthritis. In fact, they may only see it when it's gone on long enough that the diagnosis has occurred, and it shows up in their medical and pharmacy spend. So, again, despite the small population of people with rheumatoid arthritis, it's not really clear why the disability rate is so low given what we know about the symptoms of rheumatoid arthritis and its impact on people's ability to continue working.

tumor necrosis factor [anti-TNF] drugs, particularly biosimilars, in helping control rheumatoid arthritis and keep employees on the job?

I can tell you what we learned from a review of adherence studies that we did back in 2018. So, IBI combed the peer reviewed research literature for studies that looked at medication adherence and people's time off from work for short term disability and sick days. And we found a couple of studies on rheumatoid arthritis. We also had the advantage that one of the studies that we found through the peer review search was one that authors from the [IBI] had written back in 2004, I believe. And what we found was that for rheumatoid arthritis, people who were using anti-TNF treatments and who were using disease modifying treatments had fewer episodes of short-term disability. And when they had short-term disability episodes, they were off the job for a less amount of time than people who were not [receiving] these kinds of drugs.

Now, in those studies, that's a pretty clear indication that people who have well-managed rheumatoid arthritis are able to stay on the job and be as productive as anyone else in the workforce. Although, the challenge, if we think about that in terms of biosimilars, is that those studies, to my knowledge, did not include biosimilars. [Investigators] would have used reference biologics.

So, to talk about the value of biosimilars in terms of lost productivity, I think what they have is a value proposition right now. They have the value proposition that they are very similar to reference biologic drugs. But as far as I know, there have not been the kinds of studies yet to show that in terms of getting people back to work, in terms of keeping people on the job, they perform as well as reference biologics. I think, again, they have a value proposition and makeup, in which they're chemically similar [to the reference product], and they are similar in terms of their ability to return people to functionality on the job or in other aspects of their life, but I always advise employers to look for the evidence.

And so, if there aren't studies right now showing that biosimilars compared with reference biologics or compared with the usual source of care have the same or different outcomes in terms of keeping people on the job, then, what I would advise employers to is ask for the evidence. Ask for evidence in terms of your own workforce, or do whatever kinds of analyses you can do, such as observational studies.

I take some of the same guidance that a clinician from Kaiser Permanente made at [a recent] biosimilars [webinar] that IBI did with the Pacific Business Group on Health. He made the comment that when [Kaiser Permanente] was switching patients from reference biologics to biosimilars, they made sure to track those patients who were now going into biosimilars. They did that tracking, testing, re-analysis even though they've seen all the studies and believed that biosimilars could produce the same kinds of results as reference biologics. I would advise employers to take that same approach. You've seen the evidence that these are going to produce similar kinds of outcomes in different populations, but you really want to know what's going on in your own population.

To watch part 2 of this interview, click 

Brian Gifford, research director of the Integrated Benefits Institute (IBI), discussed employer challenges with managing expenses associated with rheumatoid arthritis and how skillful management of rheumatoid arthritis can keep employees on the job and reduce expense.

Part 1: Brian Gifford on the Hidden Costs of Rheumatoid Arthritis

Here are the top 5 biosimilar articles for the week of August 31, 2020.

Number 5: British Columbia's Pharmacare prescription coverage plan entered into its 

 of the program this month, where enrolled residents who are receiving reference rituximab will be switched to 1 of 3 biosimilar versions.

Number 4: Lupin Limited and Mylan have launched the 

 Nepexto in Germany for the treatment of several inflammatory diseases.

Number 3: Biocon Biologics and Mylan said they have launched the long-acting insulin glargine product Semglee on the US market and hope to obtain 

Number 2: Continuing with its string of recent biosimilar launches, Cadila Pharmaceuticals has put an 

Number 1: As the global pandemic cases topped 25 million by late summer 2020, many biosimilar manufacturers had 

 to find treatments for coronavirus disease 2019 (COVID-19).

The Top 5 Biosimilar Articles for the Week of August 31

 (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life Sciences' Medical World News, The Center for Biosimilars

 is pleased to welcome Surya Singh, MD, president and owner of Singh Healthcare Advisors LLC, based in Lexington, Massachusetts.

Are payers preferring to cover multiple biosimilars of the same drug or are they keeping it narrowed to 1 or 2 biosimilar versions and why? 

 I think that question really gets to the heart of the competitive dynamics. So, a payer deciding to prefer multiple agents rather than 1 really depends on how much value the entity on the other side of the negotiating table thinks that they can derive from offering a better deal, essentially at a lower cost and a larger reduction in cost from the discount rebate.

And so, if the deal is good enough, I think that you're going to see people narrowing the biosimilar on the formulary to just 1 particular biosimilar product. And then, there are lots of examples where multiple biosimilars are covered and both the patient and provider have fewer restrictions, or it's based more on inventory and product selection by the provider than it is by formula or requirements. But usually, that's a marker of there not being a competitive dynamic that would lead people to reduce their price further in order to get narrower or even exclusive coverage.

CfB: What do you envision happening when, say, if 9 adalimumab biosimilars come onto the market in 2023? What will formulary options look like?

 So, adalimumab (Humira) is the largest drug [by revenues] currently. It's going to be a new chapter in competition, because I think it will enter into this highly competitive market [with many biosimilars]. Whether there will be the ability to be able to really treat those new biosimilars interchangeably remains to be seen. I actually don't know offhand how many of [those biosimilar companies] are planning on pursuing biosimilar versus interchangeable designations. But as it gets closer, I will be tracking that closely, as many people will be.

I think the most safe set of assumptions about that situation is that with enough competition it's still not going to look like a generic type of price erosion, but with 9 biosimilars we should be able to get a greater degree of price reduction than what we've seen in the biosimilar categories that have launched today. And the stakes are very high, as has been well documented and publicized. There have been a lot of inflationary price increases for reference adalimumab over the years. I expect to see for biosimilars—or rather, I hope&mdash;I hope [price reduction] happens rather quickly. But it probably will take a couple of annual bidding cycles for the effect to take hold.

CfB: To what extent is the promise of biosimilar access and affordability a reality based on these factors?

Surya Singh, MD, president and owner of Singh Healthcare Advisors LLC in Lexington, Massachusetts, discussed the future for the US adalimumab market and whether biosimilars can deliver on the promise of lower cost health care.