 Biosimilars that are currently available in the oncology space—the first one approved was filgrastim; Sandoz was the first one that got approval. Then subsequently one of the products from Pfizer Inc was approved, Nivestym. Prior to that, though, there was a drug called Granix that was approved. Now there are about 3 more biosimilars approved in the therapeutic class as well. One is pegfilgrastim. That of course is supportive care, Udenyca. And then there’s a drug called Fulphila.

Then 2 more drugs approved in the therapy class, which are trastuzumab and the bevacizumab. Both of these drugs are in the regular therapy class approved just in last quarter. With the entry of so many biosimilars in the oncologic therapeutic market, we do expect to have a significant change the way physicians prescribe that. And when we’re looking into the value-based model going forward, these drugs are going to play a tremendous role in helping physicians, patients, providers, and payers.

The efficacy and potency of biosimilars are measured based on the totality of evidence. FDA created a separate path back in 2009 under the BPCIA [Biologics Price Competition and Innovation Act], to help incorporate safety, efficacy, and the lack of immunogenicity of the biosimilar. And the FDA created a path called the totality of the evidence evaluation, where multiple points are measured beginning from the structural similarity, to the analytical variance, to the chemical composition, as well as PK/PD [pharmacokinetic and pharmacodynamic], and immunogenicity. And if the compound with all the totality of factors is identified as very identical to the parent compound, the trial does not have to be done in the clinical space, simply because the FDA has understood the structural similarity as well as other aspects of chemicals. If they are more similar to parent compounds, then there will be no difference in efficacy as well.

For example, the drug called Udenyca was approved based on the totality of evidence, and trial in human volunteers but not in actual patients.

Available Oncology Biosimilars and Their Efficacy

 A biosimilar is a compound that is produced by living organisms. It bears structural analytical similarities as well as chemical compositions that are pretty identical to the parent compound. It also has the similarity in the pharmacokinetics, pharmacodynamics, and immunogenicity. Safety- and efficacy-wise, it’s pretty identical to its parent biological compound. And they are different from generics. A generic is 1 simple chemical that could be broken out into multiple small tablets. The biosimilar is actually a lot more complex and complicated to manufacture.

Biosimilars, because they are a new class of drugs, the patients and physicians are still learning to understand what it is. The traditional concept is the biosimilars are identical to generics. That’s not the case. Again, there’s a more complicated process involving manufacturing, purifying, or identifying, analyzing, and evaluating a biosimilar.

Sometimes hundreds of millions of dollars are spent for biosimilar compounds because of the complexity of the way it’s manufactured. Physicians still are learning about that as a new class. The biosimilars came to the US market in 2016, and physicians are still learning about what they are. Patients are having difficulty coming to understand that they’re not inferior; there’s some perception that biosimilars are different. In terms of its efficacy, they are not. I think the FDA has provided a very rigorous path for a biosimilar in the pathway 351(k). But look at the totality of evidence. In my opinion, biosimilars are identical to parent compounds in terms of efficacy, safety, and, immunogenicity.

It’s somewhat more complicated and confusing compared with the parent compound, and I think there are genuine reasons. For the FDA to track down anything that is a biosimilar compound, they want to make sure that postapproval process, the FDA and the regulatory agencies can track the safety and efficacy of the biosimilar. Instead of giving all biosimilars 1 single name, because the FDA expects multiple companies to come in the same biosimilar space, they give a 4-letter [suffix] for safety and efficacy, as well as any adverse events to track down the biosimilar by the last 4 letters. That could be assigned to the unique Q code, so we could track the Q code and the last 4 letters attached to each biosimilar. Anything that’s led to that specific product can be tracked.

What Are Biosimilars?

Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP:

 Similarities and differences of biosimilars versus the original product—that’s a great question to look at. We’re looking at differences between a brand-name product and another product, just in terms of clinical trials. Our main focus has always been to look at the differences, right? That’s been our goal. One is better than the other. One is actually superior than the other in terms of treatment.

That doesn’t fall into the same view or equity when we’re taking with the biosimilar from a patient. In fact, we have to switch that. We have to say that these 2 drug therapies—a biologic is a brand-name product; the biosimilars are also a biologic&mdash;will have similar outcomes in terms of safety and efficacy and also outcomes for the therapeutic indications. So we’re looking at that patient-sensitive population.

In many cases we may see some small variations, but the overall FDA approval process looks for compelling evidence. What that means is we take the preclinical, the analytical, the phase 1—based pharmacokinetic and pharmacodynamic activity, and the immunogenicity profile—on top of that phase 3 study that this was actually studied in&mdash;to address the actual FDA indication.

When we take a look at the sensitive populations, we look for a similar efficacy profile for that patient on the actual brand-name therapy versus the biosimilar. Therefore, we’re not looking so much at differences; we’re looking at similarity. That’s when the whole package for approval comes into place, and that’s for a biosimilar. We’re often tainted with the idea that we have to make a difference in outcomes, when in truth we’re looking for similarity in outcomes, both from the actual adverse effect profile and the safety profile itself.

 Biologics and biosimilars are pretty identical as far as their safety and efficacy are concerned, and that’s one of the reasons why the FDA has allowed parent compounds of the reference molecule to be approved in multiple indications. The biosimilar does not have to undergo studies in all indications. Once a biosimilar is approved on a specific study, it can be extrapolated where it will have the same efficacy in all the other indication that the FDA has approved the parent compound for.

In my experienced opinion, outside the manufacturing process, as far as structural variance is concerned, as far as efficacy is concerned and safety is concerned, biosimilars are identical to the referenced biologic.

Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: 

How do the dosing variations compare with the biologic and biosimilars? When we’re taking a look at these, the biggest thing we’re looking at is the safety and efficacy profile. But there can be some variation on how that drug is distributed. For many of us, we can find out, for example, that with one biosimilar, it comes only in the syringe. Even though the original biologic product had the availability of, for example, a vial and a syringe to be given for smaller dose in certain patient populations. In those cases we may have some variations based on usage. In other cases, we may actually the availability of a single-dose vial versus a multidose vial.

For example, there’s another biosimilar out there that was just recently approved that will see multidose vials. What that does is it allows us to conserve and reduce drug waste. In terms of the availability of how that drug is administered for the biosimilar versus biologic, that may lead to 1 preference or another. In some cases, those numbers may be very small for utilization of that administered dose.

When we take a look at storage facilities and look at temperature storage, that may have an impact based on facility site. For example, you may not have enough space in your refrigerator or your inventory area. We may actually have a certain compound of products—you can withdraw those out&mdash;which may also be limited. Any type of facility that can implement either extended storage, or a cold, sensitive product. We’re look at cold-chain supply, and these product lines may actually help configure what the best biosimilar or brand-name product is.

Usually they follow similar types of rationale between them. It’s not often a consideration, but if we’re taking a look at available product—which may actually come in a multidose vial and may automatically lapse&mdash;we may say, “Hey, this is a great biosimilar. Let’s choose this because it decreases the overall drug waste, which may be an issue or consideration when we take a look at these patients.”

Are Biosimilars and Biologics Similar?

Dispensation and switching—that’s a great question. We often have to take a look at what that means. When we’re looking at switching&mdash;you know, interchangeability&mdash;a number of different names are out there, and they all don’t mean the same thing. If a product is actually being utilized, for example, under one indication&mdash;and we have a P&T, pharmacy and therapeutics team, which addresses that&mdash;in many cases what will actually happen is we will switch those therapies based on something called a therapeutic interchange.

We can switch that based on current lines of treatment indications and also current lines of indication based on the support within your healthcare system, or a large system overall.

Now, can switching automatically be done? Absolutely not. It has to be aligned based on your own institution’s formulary. Where it is automatically being done is not so much the institution. If this is an inpatient-based treatment designation, in those cases what’s happening can be done. That therapeutic interchange, which we’ve been doing many years, can be done automatically. However, when it comes to the outpatient setting, many of the guidelines or criteria for a P&T are often invalidated based on payer preference. If one payer actually defines to use a biosimilar, another may actually find another biosimilar preference.

Across the board, you may actually have to align with what the payer says. Therefore, they will dictate what drug product you can dispense. And substitution, based on a physician preference, is not always the case or even the hospital preference. What it comes down to in the outpatient setting is a payer preference, and we’re seeing more of that. By next year, I think we’ll have a more defined premise for what those will be and how different institutions—whether a small community practice, a large community practice, or a large hospital or health system&mdash;may have some of those discussions early on. But one of the concepts is we have to address what the payer defines when looking at the actualization in the outpatient setting.

The definition of “highly similar” means you’re mimicking a similar structure and pattern to what you would see in the biologic or brand-name product. The originator product, again, can have some similar changes as time passes. We often hear that a biologic today is what a biosimilar used to be. Now that change over time can actually occur regardless of the biologic, and that can also occur regardless of the biologic, and that can occur also with manufacturing changes.

When they’re taken with that highly similar profile of biosimilar, when it comes to these mechanisms, these workflow patterns, we’re looking at some of the actual postanalytical, preanalytical data sets in clinical studies. Those clinical study pieces will also help address that similarity in terms of outcomes and efficacy. We have to actually have a bifurcation, a split in which you’re taking a look at the preanalytical phases—the early phases of clinical development coming into pretesting within a human&mdash;and actual clinical studies. That includes your pharmacokinetic and pharmacodynamic capabilities and lastly your sensitive population with that phase 3 study.

Can Biosimilars Be Switched?

 There are numerous pathways or steps that we have to address from either a biologic standpoint under a BLA [Biologics License Application] pathway, or a biosimilar pathway, which is approved through the 351(k) pathway if I’m not mistaken. And that occurred through the Affordable Care Act, ACA.

When we’re taking a look at any type of product, regardless of whether it’s a biologic or a small-molecule entity, they always have to go through fidelity checks. That means we have to check that it’s the right product—no fidelity issues. That the actual biologic agent doesn’t have any changes in terms of maybe a pH change or structural change and certain post-translational modifications as well. The FDA does a great job validating those checks across the board with the company. In addition, you know, if there are any variations, they’ll look mostly at the, again, preclinical data set to see if there are any changes throughout the structure pieces for the originator biologic.

When we take a look at a biosimilar, we do the same steps as well. But again, now we’re looking at this from the perspective of approval. When the FDA reviews the actual package for FDA processing, they’ll first check again the preclinical studies, which I think we did a good job discussing, but also the phase 1 and phase 3 studies as well. That whole package has developed.

As time goes on, maybe a manufacturing change can occur. Variations can occur in terms of the actual production line; therefore increasing the capacity of that biologic for use. We’ve seen it before with some biologic therapies early on because of increased utilization and increased need to the patient population. In those cases, there will actually be a consistent discussion with the FDA and the pharmaceutical company to make sure those checks are in balance and in validation of the product.

In the EMA [European Medicines Agency], in the European Union, they’ll actually have very transparent processes. Therefore, anytime a post-translation modification change occurs, manufacturing change, or other variations—which may include a cell molecule or the variations for buffers or solubility&mdash;those all are provided to EMA in a much more transparent manner. And so we utilize some of those guidelines and information pieces to address and check the biologic pattern for the biologic or biosimilar as well. In a nutshell, we have several different checkpoints across the board that have worked with the manufacturer, but also the FDA is aware and compliant with those informational pieces.

The definition of extrapolation, the understanding of it, is very interesting. When we’re taking a look at it for different disease states, and we can go from everything from a rheumatology disease state, as we’ve seen with infliximab, to those of other therapies. In oncology we can see the extrapolation vary based on indication. For example, if you have Neulasta, you have only 1 indication, so really there is no need for extrapolation. When we start taking a look at oncology, the extrapolation for the FDA-approved indications makes sense as we’re looking at those patient populations. Because again, we’re really addressing the fact that we may have 1 or 2 sets of populations in these cases, and then you extrapolate those indications.

That does make sense; it’s actually understanding that by utilizing extrapolation, we reduce the overall number of clinical studies needed to get the approval. If we mimic every single clinical study out there, we’d increase the cost of that biosimilar because you have to do more studies, which means you have to do more of an analytical piece, more clinical studies for patient populations. Therefore, there is increase in the cost. The question also comes up whether you extrapolate for off-label indications. I think that’s an unknown.

In fact, in many cases where you may not have extrapolation to all indications, due to the patent litigations, or to patent issues in regard to that, that will also be another unknown. So we still have some unknown areas of development, which can include patent-based issues for certain types of off-label indications or labeled indications—the former being more of an important piece. If you have something called the “skinny label,” for example, you have 6 indications due to some patent pieces, and the actual biosimilar carries only 4 of those, what do you do with those other 2? What does that off-label piece mean? How do you address it? That’s an unknown right now.

With the current approval of some biosimilars with the pending approval of the actual rituximab, Truxima, being released, I think we’ll have a better understanding how the payers define that. Because really when it comes to off-label, it’s all dependent upon the payers. Again, it’s kind of a point in question, do we consider a skinny label with missing indications to be off-label if the brand-name biologic has it in its full patent inclusion?

I think that’s going to be a question for that piece. In addition, will the extrapolation occur there? We don’t know. Will payers define that extrapolation to include all and, therefore, have a variance on the next extrapolation piece too? We don’t know. I still think we’re kind of in that neophyte, nascent area for biosimilars and also what those patents include.

In Europe they have a very different type of regulation with patent inclusions, but in the US we have some variations. We have that interpretation of the extrapolation for skinny label—based indications will be a very important piece. In addition, if we have certain therapies that have a very large off-label inclusion, having many different types of off-label therapeutic indications. What I mean by that is there may be phase 2 data, but there was never an actual inclusion of the FDA indication. We use it very often off-label. Will that also carry forward too? We don’t know. Hopefully it does, and the extrapolation piece for those indicated FDA pieces are still being realized. For the off-label, I think that will also be in discussion.

The FDA Approval of Biosimilars 

The definition of interchangeability, and also the capabilities of what it means, was recently approved by FDA. The idea of interchangeability is that you can actually switch between the brand-name and biosimilar-based products without leading to any changes in safety or efficacy. Imagine you have a brand-name biologic A and a biosimilar B. The patient can change between A and B at any point in therapy on a consistent basis, and there will be no difference in outcome or safety and efficacy profile.

That becomes an important standing issue. What you’re saying is, the drug product has enough confidence, based on clinical studies, to show no difference. That really provides that extra layer of support to get there. There are already studies that have been done that actually have a similar-based biosimilar valuation when you’re switching between product A and product B, and the outcomes have no difference.

Whether those same companies will need to do added studies to address it will be an important question. In addition, there is the interchangeability status. The definition was just approved. Will companies go back and do extra studies, which will lead to higher costs? We don’t know. What we do know is the fact that you do have interchangeability will allow for the actual switching, the interchangeable switching, to occur between the biosimilar and brand-name products. That in itself will be very important. When it comes to oncolytics, I don’t think we actually have to worry about that too much. Supportive care will be of importance, but the therapeutic oncology therapies will usually be staying the same. So if you started on a biologic, the brand-name product, you’ll probably stay on that, unless there’s a patient relapse or other cases where you may switch.

When it comes to non-oncological therapy, like insulin—for example, when insulin becomes a biosimilar rather soon&mdash;that will be important to understand at the actual specialty pharmacy or pharmacy counter, because you’d be able to switch automatically, based on interchangeability designation. Therefore, the patient may switch it just as we’ve been doing for generics for many years.

What is the current availability of interchangeability based on designations? That is a great question, and the answer is, no. It’s actually a quick question for me. There are currently no biosimilars with interchangeability status. That’s important to know because we also have to understand that the FDA and interchangeability status, the actual document—which initially was draft document for almost 2 years&mdash;was finally finalized this year. If we’re looking to search for that, there was no means to do it because there was no pathway to the interchangeability status.

That also adds into other discussions, because over the last few years we’ve seen a large number of states that have new laws associated with biosimilar interchangeability. The United States has numerous laws, and each law is different based on the state. One could be as simple as actually having that understanding of a biosimilar within the EMR [electronic medical record] system, and that allows you to have an understanding of it.

In other cases, if you switch under a biosimilar, you have to notify the physician’s office. That can be a simple fax. If that does occur, will that fax even be sent to the physician? We don’t know, because many offices get 100, 200, 400 faxes a day. It may be compiled in a whole list of faxes. The interchangeable designation, the state laws, may have varied impacts. We do know the state legislation undergoing right now, but the actual initial guidance by the FDA allowed for the pharmacist to switch, based on interchangeability, without notification to the physicians.

We have a federal law, which says 1 thing. We have a state law, which says something else. So there may be some variation based on implementation, based on notification, and based on any type of measurements associated with states that do not make the physician or the prescriber aware of biosimilars or the biosimilar legislation. There’s a lot of important information going on at the state level, but right now we do not have interchangeability.

When we’re taking a look at the biosimilar safety and efficacy position across the board for a biologic or biosimilar, the FDA data indicate that there’s no difference in outcomes or adverse event profiles. That’s already been based on the clinical trials, or clinical trial. It’s also based on any other adverse effects, including immunogenicity, when we’re taking a look at those antibodies or looking at pharmacokinetic or pharmacodynamic capabilities with biosimilars, too.

In all these cases, those data have already been there. They’ve been supported, published, and provided to get that drug approved in those indications. So if you’re looking at the indications the biosimilar has been approved for in the sensitive populations or the extrapolation pieces, I think that understanding is well developed. In fact, that solidifies utilization of biosimilars here in the US [United States]. Don’t forget, the EU [European Union] has been doing this for almost 12 years now with biosimilars implementation. All we’re doing is piggybacking off those current indications.

The 1 thing that is new for both our sites is utilization of biosimilars in the curative setting for oncology. That changes the game much more than expected. Because when we’re switching, when we’re understanding the biosimilar cascade, there has to be confidence—which, again, is provided by the clinical trials but also by utilization&mdash;that a biosimilar will maintain that curative indication in those populations.

The safety and efficacy of biosimilars still need to be taught, and I’ve been speaking about biosimilars for the last 2-and-a-half, 3 years. There’s been a slow uptake happening, but still there’s a lot more education that has to be done because physicians are too busy, and the technology and development of the new drugs is outpacing our capacity of absorbing all the information. The manufacturers have to do a lot more in providing education about the new path for the biosimilar, the totality of evidence, the safety, the efficacy, and immunogenicity.

The FDA Pathway for Interchangeable Biosimilars

Luckily I have a lot of experience with biologics. We even have more experience with biosimilars, just based on what we’ve implemented as usual. Across the country I think we’ve seen a large uptake in biosimilars, more simply the supportive care. The only time we’ve seen institutions have issues or address them is based on payer pieces. We’ve seen some variation based on who supports what.

For example, 1 payer may have a preference for a biologic, but then another part of their portfolio may include biosimilars. Or we may have 1 payer request 1 type of biosimilar but not another. So we have a large amount of detailed work on this experience in the outpatient setting and inpatient setting. The identification of biosimilars has been rather easy to address. Implementation has been more from an educational standpoint—there’s still a dire need out there to understand.

But the piece of the puzzle with the actual biosimilar, understanding, utilization, and also education really have been at the level of when to switch. Addressing it with your EMR [electronic medical record] system, looking at it in terms of patient implications and also physician prescriber preferences, and also implementing that based on the payers, because you do have to deal with financial pieces. How to you approve it? If it’s not approved, do they actually want another biosimilar? How does the prior authorization process occur?

That all takes away from direct patient time as you’re trying to get it approved. The payer interaction based on a facility and prescriber has been an important discussion as well.

We have adopted biosimilars very early on in our practice, and as soon as the first filgrastim was approved in 2015, we adopted that in our practice. So we have almost 4-and-a-half years’ experience with the biosimilar filgrastim. As soon as the pegfilgrastim was approved, we adopted that as well, so we have another year and a half of experience of second compound. We’ve recently adopted the 2 new biosimilars, which are bevacizumab as well as trastuzumab. And we have almost 5 years’ experience of biosimilars, and we’ve not seen any difference in the outcome, safety, or efficacy of replacing the referenced biologic to the biosimilars.

It all comes down to decreasing cost for the patient, which biosimilars do, and also increasing access to the patient, which actually biosimilars do as well. By reducing that overall cost, you reduce not only the overall healthcare cost but also the financial burden to the payer, because of the reduced cost of that drug therapy, and the actual out-of-pocket burden to the patient. If that occurs, it allows for overall decreased cost to the health system for the actual overall healthcare system of the US [United States] and other countries globally.

We have that availability of a drug therapy. The switching is dependent on the preference based on payers’ institutions. But overall utilization is based on decreased cost, which is kind of a switch in this era of increasing cost for globalization of biologic therapies, because newer therapies carry a higher cost. By using the biosimilar, we reduce the overall cost to the patient and other patient populations well.

We choose biosimilars when we can simply because we are part of the value-based care model and part of the Oncology Care Model. One of our targets is to reduce the total drug cost, and biosimilars often reduce the drug cost without compromising the outcome. So when possible, and when the drug is approved by the FDA for an appropriate indication, we rapidly adopt those biosimilars in our clinic as an attempt, and we just go ahead and run with it.

When do you choose between 2 different formulations of biosimilars for trastuzumab? Right now it’s kind of a mixed question. We only have 1 available in the US. The other 1 is approved but still pending release,* and I think next year we’ll probably expect about 2 or 3 of those same biosimilars in the area as well coming out.

Right now the choice is rather limited. Really the choice would be based on payer preference. Again, insurance preferences. We’ve seen 1 major payer actually approve the biosimilar, so that will be their preferred utilization of that therapy. In addition, there may be certain pieces that preclude us from using that biosimilar. That may be clinical studies, which is an important discussion, or any type of preferences with certain institutions as well.

At this point in time I think it’s very early for us to say when we would choose which 1 or which 1 is preferable. There may be certain variations that make it more likely to use it, like a multidose vial versus a single-dose vial for the actual biosimilar, which has been a question as the initial biologic had a multidose vial that decreased drug waste.

The second piece of that will be looking at what the preference is. For many prescribers, for many physicians out there, there will be some questions as to when to utilize a therapeutic curative indication with the biosimilar versus the biologic. Now that’s come about through several different surveys at ASCO [the American Society of Clinical Oncology Annual Meeting]. It was published in 2017 if I’m not mistaken. There’s an abstract in 2018 as well, in which the authors had found a preference for the use of the brand-name product for up-front curative therapy. Again, there is less hesitance to use a biologic curative therapy in second-line or refractory setting.

Getting familiar with this will take some time. But in the US, I think we’re going to see some major impact coming from the payers to switch automatically, so I think that will be an important discussion.

Right now we have only 1 label, so we don’t have to kind of look into the other part, but we will look into the payer factors that we have to be cognizant about: the payer coverage, the patient’s out-of-pocket cost, what kind of supporting programs that the manufacturer has, the supply chain. When we have multiple competing biosimilars—in the trastuzumab space, for example&mdash;we will lean toward the company that has longer experience, that has a predictable supply chain, that has a good patient-assistance program, that has a low patient out-of-pocket cost. And the overall cost to the system is low. We look into multiple factors when we make a choice of 1 versus the other biosimilar. At the same time, we have to look into payer coverage as well.

Deciding Which Biosimilar to Use

Looking at the current areas of development for biosimilars, you can utilize these in the up-front setting or relapsed-refractory setting. When that preference occurs is still an unknown area. I think that when we’re continuing therapy, we’ll probably continue these brand-name therapies based on continualization in the curative setting. Again, the key question here is curative. There will be a preference early on to continue with that brand-name biologic therapy. As time goes on, in a year or 2, we’ll see more and more uptake of the biosimilarization.

Even though the preference is there—by a physician team, by team members&mdash;the payers will actually define what we use, because we have to get prior authorization of biosimilars up front or biologics. Based on the current utilization or integration of what those policies are developed as, then in these cases&mdash;even though they may have a preference or they may say “I trust one biologic rather than the biosimilar”&mdash;we’ll see a payer define that early on. There’s a consistent communication based on the payer and institutions defining what that actual pathway is.

When the next step evolves, that will be a discussion on when to integrate that in the institution and also how familiar you feel with those drug therapies as well. That next step is part of that educational piece, which is truly a lack of integrating those biosimilars into the next-step pathway. When we start taking a look at biosimilar integration, over time, we’ll see more familiarity because of use and adverse-event profiles, which should be different, becoming a mainstay of those discussions. That familiarity will bring about increased utilization for physician and team members as well.

Biologics and biosimilars—let me go back to biologics first. Biologics have really revolutionized the treatment of cancer patients. Until 15 years back, all we had were some highly toxic chemotherapy that was almost, like, the bomb that you would use in a large dose and then hope that the cancer tissue dies and the normal tissue recovers.

The biologics target the specific cell, getting a specific marker on the surface. Biologics have revolutionized the management of cancer patients. But they’re really expensive, and the biosimilars have allowed us to replace expensive biologic drugs with relatively less expensive ones—not a whole lot of difference, maybe 15%, 20%, 30% less, but any savings to the system is savings. That’s why biosimilars have been very promising for continuing the accessibility and affordability for cancer patients in our country.

How Biosimilars Have Impacted Cancer Treatment

Mylan has started providing the aggressive support program, an advocate program that really helps practice assimilation in a better way. Pretty much most of the manufacturers have started doing a similar program. Again, this was more like a response to the demand from the market that multiple manufacturers started developing the support programs.

It does actually cover the patients who are not really insured and patients who are commercially insured but their out-of-pocket cost is too high. Within the guidelines of the payer world as well as in the restrictions of the CMS-CMMI as to what they can do and what they cannot do, they have developed a program that helps patients access drugs better.

Looking at patient support for biosimilars is a key discussion. The majority of the patients who come in throughout the country, especially for cancer, have to be looked at for patient assistance, manufacturer drug support, and foundation support, to name just a few. That usually occurs in the outpatient setting, but can occur for inpatient utilization as well. Many of these processes that occur, including database registration, patient registration, etcetera, are sort of looking at all these different pieces through a 1- to 2- to 3- to 4- to 5-piece basis.

When we’re looking at that, what makes this a little different is that when we’re looking at biosimilars, you have to address it from the biosimilar standpoint. Making sure first you don’t switch between the brand name and the biosimilar, which can be an easy error to occur. But also when looking at the patient assistance programs, one of the key pieces will be how easy is its use, how user-friendly is it, and in many cases how it applies to the patient.

We always have to discern some of those from the patient assistance program, or PAP, or medication assistance program, depending on what word you use to help with those patient populations. In many cases, some of these are more friendly, more easy to use. They have a database; everything is online. All of these hopefully apply for the patient and, therefore, require less work on patient member teams to start that patient on therapy, to decrease the interval from the time that drug comes in to the time the patient can get the drug, and to address any free drugs—in which that patient has that drug therapy in hand for application for their disease treatment.

For biosimilars access, we ensure, first of all, that they are available in a constant supply chain. The second thing we look into is the payer co-pay, because we do not want the patient to be stuck with a huge amount of out-of-pocket costs if a payer does not cover it. If needed, we reach out to the manufacturer and ask them for their help to ensure that as we look at the eligibility verification. We look at the coverage policy. We also have safety net programs of different manufacturers.

Are there differences or easier administration with the biosimilars and biologic? That’s a great question. There are new drug therapies, biologics, which have differences in administration. We’ve seen the subQ [subcutaneous] formulations come up recently with 2 of the biologics. There may be even more as the future develops with new biologics coming into the US system and utilizing some of these new technologies, which allow for subQ administration.

If you look at the ease of use of maybe a biologic versus a biosimilar, there will be a lot of discussion on that: which is actually less expensive, which is less expensive to the health system, which is less expensive to the patient? I think there will be a lot of discussion. Because if you go to a very busy healthcare system, they may prefer 1 type of therapeutic agent versus another. They go, “It will decrease my chair time, the patient comes in, they’re in and out in less than 30 minutes.”

In other cases you may find out that the utilization of biosimilars will be directed to lower cost. If that’s the actual piece as well, you may have different institutions define themselves based on what the ease of use is and also, in many cases, why they’re switching. Switching is going to be based on the lower cost of the biosimilar to the patient health system as well as the payer definition for it for their approval process. We’ll see those switches actually occur in concert.

Ease of switching is not so easy. When we’re taking a look at this, there’s a lot of work that’s done. We always talk about the number of people involved in healthcare. In many cases it’s almost like the military, where for every person on the frontline, you have several people backing and supporting them. It’s a very similar case when you have a physician and many different lines of service that we have to develop. You have your pharmacy team, your nursing team, potentially your nurse practitioner, your PA [patient advocate] team, your financial advocates. A number of different people are involved, including your IT [information technology] team, which is working on this. For those changes you have to go through all those lines. Therefore, switching is not as easy as you would think, because you have to have all those different pieces being addressed.

Specifically, it will be the patient and the prior authorization process for the actual insurance company getting that approval done. If there are variations based on what they approve versus others, or certain specific biosimilar preference, they’ll make it a little tougher to actually switch.

Assimilation of biosimilars does create some initial hiccups. Simply because it’s a different compound, we have to educate our employees. We have to spend more time with the patients. We help them understand what they are and that they are equally effective.

Coverage also becomes an issue. Most of the state Medicaid agencies don’t cover biosimilars even now. And that creates a problem because 20% of the patients are clearly excluded simply because state Medicaid agencies have not kept updated with the peer coverage policy. These are some practical challenges we face. Also the patient assistance program, access to the drug, incorporating them into the EHR [electronic health records]—all these factors are variables that we have to look into when we use biosimilars.

Patient Access to Biosimilars

Looking at biosimilars and the economic impact right now, it’s a valuable asset to the patient. One of the key important features is that we’re decreasing cost. Often we talk about high-cost therapies, we talk about utilization of high-cost therapies, because of the curative intent, because they improved outcomes, because of the variation on newer therapies coming into place, which are now establishing a new standard of care.

When biosimilars first were looking to the US market—really kind of obliging to the EU [European Union] data, which had been published for many years&mdash;we had seen the overall decreased costs. In some cases ranging from $50 billion to $250 billion in equal savings in the US healthcare market. Those studies were done based on a premise that all the biosimilars were coming to place at a certain point in time. However, we’ve had some delays. So it would be great to see an adjustment on those different pieces as well.

As we implement the biosimilars into the US market as other biosimilars come into the US market, we know competition will drive down costs. And driving down costs, like the old adage, will actually improve patient access. In competition in many cases will help those costs be reduced for patient population as well.

The one thing we fear is that it will be less of an advantage to use biosimilars in the US based on cost reductions. I think those pieces will be an important discussion and an overall piece to address. But the overall look at how biosimilars will come into the US market and decrease cost will be advantageous. But the one piece, even though we’re addressing costs to the patient and the healthcare system, will be the expanded access to other therapies in the US healthcare model.

If we decrease the overall cost of a biologic, we can increase expansion to other therapies, like immunotherapy, the more likely target agents. And giving Peter to pay for Paul—or is it taking from Peter to actually give to Paul in these cases? Sorry for the screw-up on that adage, but looking at that change or transfer of one therapy for another really will help other patients in the long run, something which is not worth that now in the US.

I consider biosimilars to be very valuable assets, particularly with the rising concerns about healthcare cost as a part of an oncological model in which we are responsible for controlling the overall costs and expanding it for our pool of patients. Biosimilars definitely help us a lot in reducing that cost.

What will the biosimilars have? What will the competition that biosimilars induce lead to cost reductions and also rebates? The piece is something that we still don’t know. The current administration is looking at change in rebate, so that’s something I’ll probably hold off for a full discussion. But we do know there are some contemporary rebate issues right now—both the payers, which have led to a lot of very interesting discussions, and op-ed pieces in the newspaper.

But when we’re taking a look at biosimilars in competition, there will be competition not only between the actual originator products in the biosimilar but also within biosimilars with themselves. That space will have a number of different therapies in there. Again, the advantage will be competition driving down those initial costs. As we expect, there will be competition to have a preference to use 1 biosimilar over another, and that will help decrease cost and actually improve access as well.

Biosimilars have definitely started showing the direction in the ASP [average sales prices]. For example, when we look in the filgrastim space, the same filgrastim is now about 40% less expensive in terms of the ASP to the payer. Similar trends have been observed in pegfilgrastim, as well as in trastuzumab and bevacizumab. We do see biosimilars are reducing the cost anywhere between 20% and 35%, and this is quite a significant saving. When you are in the value-based care model, it does help in addressing part of the budget that we have to be strict to.

We’re seeing a lot of discussion on biosimilars and cost, and what those reductions are right now. We’ve often discussed for many years what those cost reductions could be, what we’re looking for, some limitation of what it should have been but wasn’t when it first came out. For us looking at biosimilar cost reductions and also integration, it’s going to be dependent on what those look like for a lot of implementation, based on health sites’ institutions.

For example, if you’re looking at maybe a 5% reduction or 10% reduction of biosimilars, that may not be looked upon favorably. You may kind of push yourself away for not utilizing that biosimilar until the prices are lower. Because a large amount of framework was developed to implement biosimilars or change EMRs [electronic medical records] for a new product. So we’ll kind of see how that’s being addressed.

For us there can a potential for increased cost reduction; that would be great. Again, 

 means the whole US healthcare system. Implementation can be practical as well as manageable for many of these indications and to decrease drug costs. Also, utilization of off-label discussions and patient assistance will help drive down the cost but also improve utilization.

I’ve already talked about a few of these pieces, really enumerating some of the discussions, but the initial cost price that comes up will need to be manageable. If we see large reduction, we’ll see a lot more utilization coming up front.

 Biosimilar pricing has really shown the promise that it was holding before. I look at a 40% drop in the ASP over a period of 4 years, which shows 10% decline. Which is great, because even if we look into the healthcare system economics, you wonder if you are able to keep the flack, which is really great for society. When we see 10%, 15%, 20% decline year by year that goes over 5 to 7 years, it does promise a large cost savings for the health system as a whole. When we look at the biologics drug, which could vary from $80 to $100 billion between Medicare and commercial insurance, that could be a substantial savings by the trend that we are seeing in the biosimilar pricing model.

The Economic Impact of Biosimilars

Will PMBs [pharmacy benefit managers] and insurance companies be the key drivers for implementation of biosimilars? I think they will to some extent, but they also have a larger partnership with the healthcare institutions and physicians. We’ll see that a lot of biosimilars are covered by the payers at this point in time. But also don’t forget, we’re under some alternative payment models right now called OCM—Oncology Care Model. That’s transitioning to a new model shortly. We just saw it open up recently with a potentially new concept as well.

When we’re taking a look at OCM, which is thought to derive a lower total cost of care with equal safety and outcomes, in those cases the Oncology Care Model and subsequent models that may occur will really be to drive down total cost of care. How do you do that? Biosimilars. By reducing total cost of care under OCM, or alternative payment models, just like that—as we’re seeing some payers participate with this&mdash;you can drive down these total costs of care. As such, you reduce the overall healthcare burden. That healthcare burden we’ve seen in the US continues to increase every year in cost. Right? Sometimes outpacing our GDP [gross domestic product] by tens upon tens of percentiles.

Again, the utilization of biosimilars in this space will only drive down cost. It will decrease overall US healthcare spending, but it may also decrease our US healthcare spending in our patients on a Medicare Part D and B—an area often overlooked because we’re talking about private payers. But as patients who are getting older have a higher risk of cancer, in those cases we can drive down those costs under those different CMS models, or Centers for Medicare and Medicaid Services models, in the older population, looking at Medicare.

That is an untouched area to drive down costs. Hopefully, as we see this increasing burden, increasing discussion on costs and those models, utilizing biosimilars will drive down the cost in the opposite way, even amid the advent of newer therapies for treatment in cancer populations.

The insurance companies and PBMs are somewhat challenges between physician and patient, and one of the commercial insurances had a policy that was announced effective July 1 that we had to use the reference biologic compound. I don’t know how they came to that. But it probably was some sort of contractual arrangement between the manufacturer, the PBM, and the insurance.

And it does become difficult because we want to work with the patients. We do not want insurance company or the PBMs to come between us and patients. Particularly when we are using less expensive, equally effective drugs, I don’t see any rationale of why they should be tying our hands down. So it does become a problem.

Fortunately, Medicare, which is one of the biggest payers in the country, has no restriction of what we can use and what we cannot use. So we are still able to support over half the patients. With the other half of patients, we need to be worried about PBMs and insurance companies dictating how we can treat them.

There’s a lot of discussion of co-pays in private insurances and also government-based insurances, as we see in CMS cases too. You can have Medicare Part D and also Medicare Part B. That’s primarily looking at our Medicare population. Sometimes patients are eligible for both Medicare and Medicaid and also some variations out there as well.

Right now the Medicaid-Medicare population, really looking at Medicare, there’s a certain deductible amount: 20%. If you have a supplemental, that gets rid of it. However, when you’re looking at Medicare Part D, if you’re buying through that, there will be a higher percentage on that population, as well as the fact that you may not have supplemental insurance. Currently there are some potential laws that are coming through the federal regulation, which are looking to decrease or get rid of any co-pays if you’re using a biosimilar. This will definitely move a quick direction implication of biosimilars in that patient population.

For our private-based preference, or private-based entities for insurance, in these cases that will all be dependent on what the PBM dictates for actually co-pays or co-shares on those costs, as well as any patient assistance or free-drug capability. I think there will be some variations because when you’re going to a government-based insurance, you can’t get some of those co-pay cards. You can’t get some of that manufacturer assistance. In those cases, you’re kind of dependent on foundation assistance. When it goes to our private payers, you are eligible for those, so you will have some variations. Unless we see some litigation occurring, and with new laws that are developed, there will be some different facets for biosimilars and co-pays as well.

The Role of Insurance Companies and PBMs on Biosimilar Access

 Taking a look at different types of health systems or payer-based formularies, it takes a lot of work to understand what that needs to be. When you had a health system, we’re addressing it from a patient’s safety profile, utilization, and other comparators as well. But the payers will help define what we get paid for. Insurance companies, when looking at the pharmacy and therapeutic discussion, will be looking at implementation across the board for that biosimilar.

If we have one payer, they may have a preference for one. If we have multiple payers, you have a preference for several. That also means we’re going to have to have a large amount of space on our shelves to keep those formularies in place.

When we take those next steps, looking at indications and discussions as well, we’ll also have to address both those pieces together. So you may have your own formulary. Or you may have the payer formulary, and therefore working to address what biosimilar or biologic needs to be on the formulary will be an important discussion. Because even though you may have it on your formulary for use, it may not be the one you’re going to be using for that patient itself, because you are defined by the payer to utilize that biosimilar.

Again, we bring back the PBMs [pharmacy benefit managers] and the healthcare plan. This is where we get somewhat frustrated. We’ve done our best to help educate the payers as well as other stakeholders. And from what I’ve heard, we are now going to be working directly with the employers. What we feel is that if a specific payer and the PBM work together to restrict the access to the drugs, which could be less expensive compared with the parent compound, we want to reach out to the employers and let them know that you are paying for this help and the health plan is asking you to pay for the most expensive drug.

We’ve seen a lot of movement, awareness, and concerns from the national business groups on health about such tricks played by PBMs as well as by the health plans. We definitely are doing our best to really throw sunshine on the options to reduce cost of care, and how factors that are beyond anybody else’s control can limit our success of once-in-a-lifetime reducing of the price in the US.

Will a biologic or biosimilar be implemented based on first-line therapy, like a curative index, or for relapsed-refractory discussions? That’s a very tricky question. We have seen preferences coming from ASCO [the American Society of Clinical Oncology Annual], where we had seen it earlier on, about in 2017, when a survey was done that said that physicians would prefer to use a brand-name biologic for curative therapies. But when it came to relapsed-refractory therapies, they were more available to use a biosimilar in that refractory-relapsed setting.

I don’t think we’re at the point right now to address either fail-first or curative therapy discussions, but I do think it may be a question in the future. However, the one piece we haven’t addressed is, that may not matter. If a payer defines us as using 1 biologic or biosimilar, it doesn’t matter what the preference is—you’re actually mandated to use that product alone. Therefore, that discussion may be pulled out for another scenario altogether.

It’s a great discussion. It’s a great contemporary evaluation of what’s happening. But I often think that we’re maybe jumping the shark to address what biosimilar biology to use, because we’d be payer defined early on.

This question probably may be answered more by the PBMs than the insurance companies. As far as Medicare is concerned, there is no question about it. I think the policy was, at one of the insurance companies I was talking about, they work in conjunction with the manufacturer, which is probably not the best. But we are struggling and we are fighting every day to ensure that access to less expensive, equally effective drugs is uninhibited and is not influenced by whether it’s PBM or whether it should be the insurance plan.

Formulary Inclusion for Biosimilars

Challenges of the provider and as a health team of biosimilars—there are numerous ones. I think we’re still at the forefront of discussing it, but we’re toward the back end of implementation. The biggest challenge is addressing what the payer wants us to use. Regardless of the situation of education, the P&T [pharmacy and therapeutics] pieces are understanding what the actual biosimilar or biologic preference is based on indication. It is the most important discussion across the board.

For many of us, that means when we’re looking at a biosimilar or a biologic, if we know beforehand what the payer preference is, that makes us have an easier time in developing our workflow or policies.

It gets tougher if you have 30, 40, 50 different insurances with different preferences. Now you’re just hoping to address this from a standpoint of saying, “Here’s which payer we use the most. Here is their preference.” But what happens if you make a mistake? If you give a biologic or biosimilar that’s not preferred? In those cases, you may actually risk a loss of revenue or giving the drug away for free, because you need to find a priori, or beforehand, when that patient came in.

The discussion on the payer index, the payer piece, to me is the most important. The second thing is clinical trials. In the advent of developing new clinical trials and new curative therapies, we have some protocols that define not using a biosimilar. You may have to have a brand-name product on hand, even though you have a preference for a biosimilar. Another important question as well.

The third, another big piece of this, is going to be the patient assistance programs. Often we rely on our patient team members, our patient assistance members, to address up front what drug will be used, what’s available, what piece of implementation will be available for that patient population as well. If we don’t know or don’t educate those members involved, from the physician all the way down to the patient assistant members—including the patients in that kind of trifecta that we always have an association with&mdash;we may cause the risk of actually giving the wrong drug, wrong patient assistance program, wrong co-pay cards, wrong free drug. Again, all important pieces of that as well, as well as billing. If you don’t bill for the correct drug even dispensed, that becomes a problem.

In fact, one biosimilar has a different unit code from the original product they used at hand, too. Now you can see the enlargement of issues occurring—not on the front end, where you’re giving the drug to patient, but on the back end, where you’re looking at all the other things that occur downstream for that patient getting administered their drug.

We have a lot of work to do. Those are some things that keep us up at night, so we try to keep our heads focused on this as well. But other issues that we’re mitigating right now are even changes in workflow development, which may be incurred by a PBM to institute a supportive care biosimilar, and that’s another big issue occurring as well.

To summarize challenges for the biosimilars, let me begin with education. The first thing, I really have to blame the manufacturers. They’ve done an appalling job of putting out resources and educating stakeholders. Unless the prescriber knows the access of liberty and economics of biosimilars, they’ll never be able to use it. That has to be done.

The second part is educating nurses, patients, family members, and pharmacists about the quality of the product, the totality of evidence, the FDA pathway for the biosimilars. The third thing is the payer coverage. Even now, with almost 20% of the patients who are on Medicaid who are not able to access biosimilars, I cannot think why, because Medicaid is a federally funded program. I’m not sure how come CMS is not going to mandate that every state’s Medicaid should cover biosimilars.

The fourth thing we talked about was the contractual agreement between the PBM [pharmacy benefit manager], health plan, and the manufacturer and how they can tie their hands down by policy. These are the big challenges that we have.

At the end of the day, this is the only way I see that we can address drug pricing in our country. It’s becoming increasingly challenging in every wing of the government. Democrats, Republicans, and the local states all are struggling to figure out how best to control drug prices, and biosimilars offer the most realistic, most optimistic view to reduce the cost of care.

We have heard a lot of discussion about everything from the physician, the patient assistance member, the pharmacist, the advanced practitioner, and all these other people. But what about the patient, right? The patient is who we’re administering the drug therapy to.

There’s a large discussion on this. How do you educate the patient about biosimilars? Do you do that education? Consent forms? Do you consent the patient to a biosimilar as well? These are largely unexplored areas. For the patient, the educational piece is still being developed. We have a lot of patient support groups across the country addressing this.

We still need to maintain and educate our patients too about what are biosimilar needs. Because there can be some misconstrued discussions, you know? For example, when Dr Scott Gottlieb, the [former] FDA commissioner, was discussing the biosimilar action plan about a year ago, there was actually a lot of information in regard to the fact that you can’t create negative information about a biosimilar, which was occurring. This actually allows us to provide the correct patient medication and also helps provide real-world evidence [RWE], something which we didn’t touch upon. The RWE portion, which is part of the pharmacovigilance piece of biosimilars, will also help assuage any fears by the patient and also the physician. There are some interpretations there, there are some education pieces there as well, and they also work for discussion just with the patient in addition to it.

And that’s just on the infusional side. When we have therapeutic agents—some right now, but more in the future&mdash;occurring on the specialty pharmacy or pharmacy side, where there is not an infusional center, they’ll all see more pieces to that puzzle as well.

How do we ensure that patients are aware of the actual properties of biosimilars and the pieces for approval of biosimilars? That’s a great question. Again, that’s a key discussion—the educational piece; the counseling piece, which is often done by many of our pharmacists and physicians; and also advanced practitioners&mdash;when we’re taking a look at these different pieces. The biggest piece will be to make sure you understand that these are biosimilars. They’re similar to the actual approved product, and they’re also indicated based on clinical studies as well. So making sure they understand the stepwise fashion and what this means in terms of biosimilars.

Don’t forget, about 20 or 30 years ago, we did the same thing with generics. We have already done that switching from a brand name to a generic, but now we’re redoing that same piece as well. What makes it a little more interesting is that it’s a biologic. We haven’t done this approach recently. In Europe they’ll switch almost every quarter or every year from 1 biosimilar to a biologic or a biosimilar itself. They’re switching every year. How do we address that from our own perspective? Again, I’ll be making sure the patient is educated, aware of the drug therapy, aware of the biosimilar, and making sure they have an understanding of what that biosimilar means to them and also to how it was approved as well.

There are a lot of different institutes out there, organizations that have attempted and also developed different educational materials. We have seen a lot of forefront discussions by FDA. The FDA has done a fantastic job of creating different educational resources for patients and providers as well. I give a lot of kudos to the FDA for really not only working on this but also pioneering their efforts to get educational. That’s the major website that I would start to recommend. But we’ve seen a lot of organizations come up with routine ASHP [American Society of Health-System Pharmacists], ACCC [Association of Community Cancer Centers]. A large number of organizations, including ASCO [the American Society of Clinical Oncology] as well. There is a lot of great work being done across the board for biosimilar educational purposes. We’ll need a lot more coming up, patient-specific work for development as well as the resources again to address this. But those are just some great organizations and also great agencies dealing with education as well.

Biosimilar Challenges for Providers and Payers

The education piece with healthcare professionals, with team members, will a long-standing case. We have some key points to address over the next 5 years, leaving us to biosimilars 102. When it comes to curative therapy—not supportive care but curative therapy&mdash;it will be the fact that we have to address the outcomes of clinical trials and safety and efficacy, really detailing the lack of difference. Not the difference, but the lack of differences among these biologic agents. Taking a look at their original product or brand-name product and the biosimilar, we’re really moving to how that drug was approved, what are the pieces to improve that drug. That’s our key mainstay for discussion.

Looking at other pieces, we’ll be including what those indications are, addressing how to look at the EMR [electronic medical record] system as well, how to integrate those pieces, and also the discussion on clinical trials. Those are just a few of the touch points we need to make across the board for biosimilar education.

We’ll also need to take a look at variations on discussion interchangeability—how that comes across, because different institutions may have recognition of something called therapeutic interchange, versus that of biosimilar-based limitation. We’ll also have to address how to look at biosimilar switching within institution. Do we need to have guidelines, pathways, discussions as well? Other points of contention, of course, will be payer-based differences. How do you address that from one biosimilar to a biologic across a board and where you have a large amount of payers, too.

There are some challenges that can be solved by increasing awareness. Biosimilars can sponsor the education program at the national meetings, whether it’s COA [Community Oncology Alliance], ASCO [American Society of Clinical Oncology], ACCC [Association of Community Cancer Centers], or multiple not-for-profit associations that sell the purpose of bringing awareness about the options of treatment. The biosimilar manufacturers should really make a significant effort to put in resources, so physicians who are on the sidelines can become aware of the biosimilars. They can also go to patient advocacy groups, as well as midlevels, ONS [Oncology Nursing Society], or nursing NP [nurse practitioner] societies to bring education and resources for biosimilar awareness.

My closing remark of biosimilars is I’ve been in the healthcare field for the last 20 years in America. And for the last 20 years, we’ve been struggling with the issue of drug price. Biosimilars offer really almost all the important aspects of healthcare to address drug prices. They can improve the access, making drugs more affordable. And biosimilars are not confined to oncology. They’re also in the autoimmune space. Biologic compounds affect every aspect of human life as long as we live. Europe has done pretty good job of assimilating biosimilars since 2006. They have administered over 700 million unique doses without any difference in outcome or any adverse reactions. I think our country should adopt and implement biosimilars without any inhibitions.

The educational topic for biosimilars will probably be within the next 5 to 7 years. We had a large, robust amount of knowledge in many therapeutic indications. When it comes to the understanding of biosimilars, we’re still in biosimilars 101, your freshman class of biosimilars.

We’re now moving to therapeutic indications. This is going to be an indication where we’re going to go with curative-based therapies. In terms of cancer, those become critical, because questions arise and adverse-affect profiles vary based on the physician’s use in an anecdotal manner. Also detailing or removing that fear of using biosimilars is needed.

How do you do that? You need to educate the team members on the data, how the actual clinical trials perform. In addition, there need to be a large amount of data or evaluation on addressing the biosimilar approval process. Because many people think that the same path didn’t occur for their product. Yet all those variation, post-translational modifications, cell-line changes over the years—which we’ve known about for decades&mdash;and the actual bench-based sciences are occurring with the biologic. A discussion on drift, post-translational modifications, all are very well known. When it comes to the biosimilar, all of a sudden it becomes, “Oh, my gosh, I was unaware of that.” That education needs to be put forth.

But also dimensions on education for implementation, for understanding those people who are not in direct patient care contact with our finance team members, our pharmacists or our team members, all are very important. In fact, even the people who are working on the payer side need to address these points as well.

I think we have a large amount of understanding that needs to go on. Even more so when it comes to rheumatology and endocrinology. For example, diabetes. These are also very important areas for addressing these patient populations.

I’m a little concerned about the manufacturers of the biosimilars for not having enough time, resources, and efforts in educating biosimilars. If you go back and look at the first biosimilar that was approved in the autoimmune space, infliximab, the market uptake was only 2% because most of the stakeholders—which included GI [gastrointestinal] doctors, patients, nurses, and pharmacists&mdash;had no idea what a biosimilar was.

For anyone now, that’s a big stumbling block in acceptance of the biosimilars across all the sectors. Manufacturers have to make a better effort in improving awareness, education for the payers, physicians, midlevels, nurses, pharmacists, and patients.

The Role of Biosimilars in Oncology