Biosimilars Require Standardization of Knowledge in the Field

Pharmacy Times sat down with a panel of experts to discuss progress toward standardization of knowledge in the field of biosimilars, with panelists including William Soliman, PhD, founder and CEO of the Accreditation Council for Medical Affairs (ACMA); Jeff Baldetti, MBA, BCBBS, vice president of product and marketing at HealthPlan Data Solutions; and Fran Gregory, PharmD, vice president of emerging therapies and biosimilars at Cardinal Health.

Alana Hippensteele: Hi, I'm Alana Hippensteele with Pharmacy Times. Joining me for a discussion on the state of biosimilars today are William Soliman, founder and CEO of the Accreditation Council for Medical Affairs or ACMA, Jeff Baldetti, vice president of product and marketing at HealthPlan Data Solutions, and Fran Gregory, vice president of emerging therapies and biosimilars at Cardinal Health.

To get us started, Will, how would you describe the state of biosimilar adoption in pharmacies today, and where should we look to grow from here?

William Soliman: I definitely think that biosimilar adoption in pharmacies has been increasing, certainly in the last few years. I know there was a report that came out by the Association for Accessible Medicines that showed that biosimilars, if I recall correctly, accounted for about a third of the market share among biologics and biosimilars in general. So, this is definitely a big increase from just 7 or 8 years ago, I think it was probably less than 10%. I think it's definitely moving in the right direction. Certainly, one of the factors that's contributing to the increased adoption of biosimilars in pharmacies is definitely the lower cost of biosimilars. I think that's going to definitely be a major driver. But I still think we have a way to go and there's some challenges, one of which, of course, is the lack of awareness and really education among pharmacists in the country when it comes to really understanding the differences between biosimilars and the reference biologic and various biosimilars. I also think there's some logistical challenges, you know, and working with pharmacies as we do at the ACMA, there's some logistical things with biosimilars, for example, in terms of storage and things like that, that can make it difficult. And the last thing I would say is in terms of the coverage and looking at the some of the nuances there in terms of the insurance providers coverage of these biosimilars and things, like for example, prior authorization and what that's going to look like for different biosimilars for that specific reference biologic. I think all of those factors probably still contribute to some of the challenges and maybe where biosimilars aren't being used as much, but it's definitely moving, like I said, in the right direction. I would imagine as more education gets out there, and pharmacists feel more comfortable that adoption will increase.

Jeff Baldetti: Yeah, it's something I’d add to is I think, to William’s point, we're definitely moving in the right direction, and in some areas, I think, we’re there. If we look at specifically, like if we look at specifically therapeutic oncology and supportive care oncology, those really first hit the market back in 2019 and some of them are above 80% market adoption. I think those are the shining examples of, you know, solid adoption and things that we'll look forward to seeing in other classes. There's definitely still been struggles outside of oncology and a lot of the immunology spaces and new ophthalmology spaces. But I think that's where we have to look to in the future; I think it'd be impossible to talk about where we're going to go here without talking about retail biosimilars and Humira (adalimumab), and then some of the newer areas like the ophthalmology biosimilars. So, I think there's a lot still to work on in those areas.

Hippensteele: What are the knowledge gaps and educational needs in the field of biosimilars among pharmacy professionals?

Baldetti: Yeah, it's a good question. In general, I think there's a lot that we’ve learned in the last couple of years, and there's still a long way to go. But kind of 3 areas I would definitely call out as the biggest ones is, first and foremost has got to be interchangeability and the associated state laws. It’s probably the biggest area where there's misunderstanding around what the designation means, what it doesn't mean, and really how it's different and unique here in the US. In the US, interchangeability is a regulatory designation. It doesn't exist over in the EU or in Canada or other developed markets. Understanding what that means both on paper and in practice at the pharmacy level is really important, especially as we have more biosimilars that have achieved the designation; it’s really meaningful on the retail side allowing for that automatic substitution. So that's a huge area. I'd say the last two would be, in general, I think the focus and growth in biosimilars has kind of pulled us back to the idea that we need more education on the general idea of biologics as a whole. The manufacturing process and why it's so challenging to do, what biosimilar companies can do, is very different manufacturing-wise than we have for generic medicine. I think education as a whole on the differences between biologics and small-molecule medicine is huge, and then the final one is more industry wide. I think, just better understanding on the pricing, reimbursement methodologies, how this works into plan design and placement of formularies. There's a lot that goes into that, whether it's the naming conventions or the products themselves. Now you've got branded, unbranded, authorized generics. So you have a lot of different terminology for these products, it's kind of exploding right now, that I think needs kind of centered focus on what this means for doctors, for patients, for health plans, pharmacies, all the above.

Hippensteele: Where are we in standardizing knowledge of biosimilars in the field?

Soliman: This is a really important area, because, like Jeff mentioned, there's a lot of subjects, right, or topics in this area, where people have different understandings of what the terminology means. And because it's a new and emerging area, you need to kind of have a standardized, codified way, so that everybody understands it in the same manner. So right now, our organization, the ACMA, we established the first-ever board certification on the biologics and biosimilars area that was launched over now 6 months ago. And really what it does is it brings together all of the key areas that someone – health care professionals and those working in the life sciences space – would need to know, to work or to be an effective health care provider in this space. It covers everything from the history and development of biologics to various regulatory and scientific concepts that Jeff alluded to earlier, a lot of the formal economic considerations, kind of the lay of the land today for biosimilars in the US and abroad, as well as knowing how to navigate the different resources that are out there as well in this area. Then finally, a lot of the clinical guidance when it comes to real-world evidence and how to leverage real-world evidence, clinical trial designs, things like that. All that's discussed within the program, and I think this is very important because we've seen in other fields where if you don't have a level setting, it can create a lot of confusion. And I think especially among health care providers today, we see some of that; matter of fact, from what I recall, the Cardinal Biosimilar Report that came out this year, cited that still – I think it was among ophthalmologists – there was only about a third that were familiar or feel comfortable with biosimilars. And so, you know, we see in certain areas, it's going up in some therapeutic areas, or specialties it’s going down. So again, we still have a long way to go in terms of helping healthcare professionals feel more comfortable in prescribing biosimilars. But like Jeff said, certainly in the area of oncology, we've come a long way. There are a lot of other areas and there'll be more emerging areas, you know, as time goes on. I definitely think standardizing this area is going to be very, very key in the next few years.

Hippensteele: How are the increases in biosimilars affecting clinician prescribing and switching behaviors?

Fran Gregory: I think that the increase of the availability of biosimilars throughout several therapeutic categories have certainly impacted the frequency at which providers are now prescribing them. We've mentioned oncology a couple of times already, obviously, the first biosimilar in the United States was available in 2015 in the oncology arena. So that really was the kickoff to oncologists having a really good, solid understanding of biosimilars. Since then, obviously, we've seen a number of additional biosimilars launch in the oncology area. Whether or not it's provider comfort with oncology products over time, if it's confidence, if it's better knowledge of the approval process, the FDA requirements that the manufacturers have to go through, or if it's just, you know, longevity in the area of prescribing biosimilars, and being kind of comfortable with that over time, oncologists have gotten this figured out. So now we need to branch that out to other therapeutic categories as well, as we start seeing the ophthalmology products, rheumatology products coming to market. We really want to see that adoption spread into those areas as well, with the significant launch of the adalimumab biosimilars that we're seeing now, we really have high hopes for that area. We really have high hopes for rheumatologists adopting these products and other therapeutic areas connected to that product, obviously. We still have some challenges in those areas. We're not seeing as quick of an uptake in some of the rheumatology products currently on the market with biosimilars in some other areas in general. I think one of the learnings that we've had is in the insulin space. I think we are all very excited about the biosimilar insulin and this is a very well understood disease and very frequently treated condition. The challenges that the insulin biosimilar saw when coming to market I think we all learned quite a bit from. So hopefully with the learnings from that and the volume of biosimilars coming to market in other therapeutic areas, we can continue to improve the rate of uptake as we continue to learn from the biosimilars already on market.

Hippensteele: Will this increase patient access to these medications? How will these medications be covered by payers as they increase in number?

Gregory: I absolutely think that the volume of biosimilars available on the market today is absolutely increasing patient access. I think that's been proven in a number of studies; there have been significant patient savings shown from biosimilars to date. We expect that to continue, and we expect also for payers to continue to include biosimilars in their formulary decision making processes. We all know this is complex, right? There are a number of financial challenges that payers and [pharmacy benefit manager] (PBMs) face in regard to formulary, management and strategic decisions. While these decisions are typically clinical in nature, when you have a line of products that all have the same clinical efficacy, the next thing that you're going to evaluate, of course, is cost or anything rebates, discounts, etc. So that's where things get a little complex and a little less clear to those of us even who are evaluating these products every day. To a patient, it can be extremely complex; to providers, it can be extremely complex. And obviously we talked a little bit about pharmacists and the knowledge that's required not only to manage through the clinical components of biosimilars and the patient concerns and addressing them, but also understanding which product is covered by which formulary for the patient that's standing in front of me or that's on the phone, on the other side of the country from me. A lot still for us all to know and understand about which products are going to be covered, particularly when we're looking at very crowded spaces like adalimumab. However, we are seeing payers and PBMs constantly adding biosimilars to their formularies and adding them to their preferred specialty product list. I think we'll see that continue. Patient savings, again, I think there's more opportunity to increase that, to pass that savings on to the patient. I don't think we're great at that yet in the US, but I do have high hopes that we will continue to push to move in that direction so that patients are the ultimate beneficiaries of the value that biosimilars bring.

Hippensteele: How are biosimilars being discussed in PharmD programs? And are pharmacists leaving pharmacy school feeling prepared for the biosimilar landscape of today?

Soliman: Yeah, that's a great question. At the ACMA, we work actually with a lot of pharmacy schools, they work with us to implement a program that we have as an elective course for them for people that want to work in the industry. We have some good insights into you know, what they offer from a curriculum perspective. And right now, they're really just scratching the surface as being introduced to pharmacists. But you know, most pharmacists leaving school don't feel very comfortable, we at the ACMA, similar to Pharmacy Times, you know, we have pharmacists that work on our team, and those that come out of pharmacy school will tell you that they are getting a very surface level knowledge, they cover the basic concepts in this area. And obviously it's a growing field, it's changing rapidly. But we definitely have got to do more to help them feel prepared when they come to the workforce, so they can adequately feel comfortable prescribing these products. I would say no, they probably still don't feel prepared. I would say that within the pharmacy academic community, even then, from what I've seen, their familiarity is not as high as it probably could be. I think part of that is that when you're working in academia, you're not in the day-to-day clinical practice, you know, are not working community or retail. So you're not encountering things as much kind of at that level. So even then, what I found at least is that their familiarity levels are very, very low. So again, I think there's a long way to go still in helping those pharmacists that are coming through the system to be more prepared.

Hippensteele: What are expectations and hopes for the future of biosimilar adoption and standardization in the field?

Baldetti: I can start and say I think in general the hope is that we have biosimilar adoption continue to grow and provide more treatment options for patients that ultimately that need these and effectively the market will start to drive more price competition, make these drugs more affordable and increase patient access. I think ultimately, from my perspective, the long-term goal is achieving a more generic-like dynamic in the market that really drives this specialty market forward for a lot of these high cost, high impact treatments.

Gregory: I absolutely have high hopes for the future of biosimilars. When we look into the pipeline, we're seeing development of products in multiple therapeutic categories that I never thought we would see biosimilars in. We have multiple sclerosis, we have some other complex, rare disease products coming to market, some oncology products that are very specific that, you know, are very high cost in nature as well. So I think the pipeline being so full of a variety of different therapeutic categories really encourages the entire industry that these products are here to stay. Another thing that I think is extremely encouraging is the cost savings to the US healthcare system overall. I always try to think about biosimilars, in the most neutral perspective, are here to create patient access opportunities, as well as to generate US health care savings so that we can continue to see innovation and new types of treatments that are lifesaving in nature. When we look at what biosimilars have done from a cost savings perspective overall, when a biosimilar comes to market or when it's close to coming to market, the entire class of molecules decreases significantly in cost. Whether that be the reference product or the biosimilars as well, we're seeing that molecule decreasing cost anywhere from 20% to 50% at that launch period, and shortly thereafter. So that's a combination again of lower prices of biosimilars at entry as well as these reference products being challenged to compete. We're creating competition in a space where there was none before which is obviously a significant win for patients in the short- and long-term. And finally, when I think about biosimilars big picture in US health care spending, part of my role is innovative therapies as well. So looking at cell and gene therapies and truly novel therapies that are very, very innovative, yet very costly to the US healthcare system. When I think about the balance of innovation in the balance of biosimilar savings that we need to see in this country to continue, you know, not to continue but to create maybe a sustainable health care spending system, we have to have continuous support and continuous uptake of biosimilars for that to work. So, the promise of biosimilars is here, it's here to stay, and I think we can only get better from here.

Soliman: Yeah, I would say the future is bright. I agree with everything that Jeff and Fran said, I think there's a lot of potential. I would the only thing I would add to all great points is that I hope that at the government level, that there can be more bipartisanship in the Congress, looking at some of the policies from a reimbursement and payer perspective, to help streamline access to these medications for patients, because a lot of times that's where the bottleneck is. I think if we can work out some of those kinks in that process legislatively on the hill, that can make a world of a difference for these products and make it easier and help incentivize manufacturers to want to invest in these products and put them out in the market. I think that's the key, that's ultimately going to be the key. And if we could do that, the sky's the limit, and we could really help to treat a much larger patient population that before wasn’t able to access these types of therapeutics.

Hippensteele: If there was one key takeaway you would all like for pharmacists to come away from this discussion, remembering and thinking about, what would that be?

Gregory: If I were to think about pharmacists, and what impact a pharmacist can have on biosimilar success in the US, it's so expansive and broad. Pharmacists are involved in the opportunity with biosimilars from start to finish. Pharmacists are involved in the pharmaceutical manufacturing process. They're involved in the strategy for launch. They're involved in pricing; they're involved in formularies. They're involved in clinical education, they're involved in PharmD programs. They’re involved in patient education, adverse event management…and one area where I think they can be even more involved, and I really wish that we could all just be empowered with is the fact that we can absolutely influence the future. Pharmacists can influence the future of healthcare policy; we can influence the future of patient acceptance and provider acceptance of biosimilars. But first we have to be educated ourselves. We need to all become experts on what this opportunity is and experts on how we can contribute to the sustainable health care system that we all desire, as well as that increase in patient access that biosimilars really, really are here to serve.

Baldetti: I think probably reiterating some points that we've already made. I mean, in general, I think the biosimilar market is working, it is driving competition and lower prices. What I would drive home for the pharmacy community is really that as we navigate into a greater prevalence of more retail biosimilars where the pharmacy-patient interaction is much greater, that touchpoint is a huge opportunity to deliver that education to the patient and ease the burden or stress of potentially switching to a product. If you're a chronic care patient, you've been on the same insulin or adalimumab product for a decade; it's a really scary experience to switch and delivering that clinical education at that point is hugely impactful to the patient's experience. There are documented examples of the nocebo effect in other countries, even in the US, where it's very clear that the patient's frame of mind in receiving a new product can determine how they feel the product is impacting their health. I think that that's a huge opportunity for pharmacists to impact that directly. I think related to that, Fran said it well, it's about educating ourselves and making sure that we feel comfortable with this. I think that we can leverage a lot of experiences outside of the US to enable that. There's at this point over a billion patient days of experience on biosimilars and the EU and other developed countries that I think we could do a better job of in the US leaning on the experience of others. I think, along with everyone else, the future's bright and we've got a great opportunity to impact the whole system in a meaningful way.

Soliman: Yeah, that was great. The only thing I would add really is that pharmacists, you know, are one of the most trusted professions. To Fran’s point and to Jeff's point, I think taking that responsibility on yourself to continue educating, growing, becoming that expert is going to just enhance your credibility, enhance your trust and ultimately make you the go-to resource for the biologics-biosimilar space for patients and for other health care providers.