Pearl Steinzor

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, provides an overview of biosimilars in the breast cancer space and lingering adoption barriers for oncology biosimilars.

Haumschild's comments came at the end of Breast Cancer Awareness Month and the beginning of Global Biosimilars Week, an annual biosimilar awareness campaign hosted by the International Generic and Biosimilar Medicines Association.

With October being Breast Cancer Awareness Month, what more is needed from providers and health systems to ensure patients have adequate access to biosimilars for breast cancer?

I think access to biosimilars is really important. It drives down the cost of care and I think allows more patients to be on treatment. But there's still some unanswered questions that exist. How do we get these biosimilars implemented into our EMR [electronic medical record]? What happens when some biosimilars are no longer covered by payers and we still want to utilize them? How quickly can we change a lot of our order sets? 

And then again, how do we educate some patients that might be concerned. They might be in curative intent. Do we have the proper education to make sure that patients understand that biosimilars are equivalent to the reference product and still provide great outcomes for them? Especially in their cancer journey for breast cancer. [We need to] let them know that they might interact with biosimilars throughout a variety of different treatment options, and they're still going to give durable responses.

I think once we get that education out, learn how to implement these biosimilars in a timely manner, we'll be a lot more successful, specifically in our breast cancer population.

What role can biosimilars for breast cancer play in improving breast cancer treatments overall?

I think biosimilars, again, will continue to provide more treatment options for patients at a lower cost. And I think that's a great thing. I think when you're creating more equitable access—you think about diversity, equity, inclusion in breast cancer—there's still a lot that we have left to accomplish. And so if we can leverage biosimilars, whether in combination or for supportive care, more patients can get on treatment or reducing the cost of the care to the provider. That's a great thing. 

When we think about value based care of breast cancer, we think about EOM [Enhancing Oncology Model] and some of those value-based care models, the more that we can leverage biosimilars and those frameworks. I think if we make more sustainable models of care, we can bring care out to the community or to patients directly

Also, can we consider [biosimilars for] home infusion or supportive care medications that patients can take at home? I think the more we can do that, and the more we make accessibility one of the key drivers, I think that's going to create better uptake for breast cancer patients as a whole and I think that's something to get excited about.

Studies have shown that oncology and supportive care biosimilars are the biosimilars with the highest market share and providers are very comfortable using these products. What are some of the main challenges still facing oncology biosimilars?

Biosimilars have good uptake now and I think there's a lot of excitement. Actually, I think oncology and maybe breast oncologist are one of the main leaders in adopting these therapies. But I think as we start to utilize them, we're seeing a little bit more difficulties, sometimes from the reimbursement side. So, if you look at net cost recover—if you're a large community oncology practice or health system—the average sales price continues to trend downward. And unfortunately, that's really difficult because that's the reimbursement for a lot of these practices. If there's no margin, there can always be the same mission. 

I think at the same regard, when we're utilizing these therapies, how many denials are we getting from our payer colleagues because we're not using the preferred biosimilar? And there's that slow down time to treatment. And when I think about breast cancer patients, we're really thinking about overall survival and progression free survival. So, every day and every minute counts for how quickly we can get them started on treatment. And the more we see delays there, I think that also influences treatment. 

Lastly, biosimilar uptake is important, but now we're seeing the reference products being reformulated to subcutaneous products. And so I think subcutaneous and a faster infusion sometimes might be more warranted, and then also kind of limits the growth of biosimilars into some of those therapeutic areas.

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Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, discusses the growth and continued challenges facing biosimilars used to treat breast cancer.

Dr Ryan Haumschild Draws Link Between Biosimilars, Health Equity in Breast Cancer

With the volume of new biosimilars coming to the market, there will be many challenges to specialty pharmacies will need to consider when handling these drugs that are unique from generic drugs, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health.

What strategies can specialty pharmacies implement to effectively manage the handling of biosimilars, which may have unique requirements compared with traditional generic medications?

Yes, the inventory management is something I have heard a lot of concern about with biosimilars from specialty pharmacies in particular, and retail pharmacies when we think about the insulins coming to market and the vast number of biosimilars that will come to market for 1 reference product. If in your pharmacy you have 20 boxes of Humira on your shelf, you're now going to have 20 × 10 different rows of Humira biosimilars on your shelf; that gets overwhelming to think about from a sheer capacity and volume and storage requirements. How many more refrigerators am I going to need to buy very tactical things that manufacturers might not be thinking about, or the FDA might not have been thinking about when we created these approval pathways and designations? Specialty pharmacies are hopefully preparing and planning for the launch of these multiple biosimilars.

Because it is a different world that we're coming into and the way that formularies will choose their biosimilar of choice, they will be challenged to maintain significantly larger volume of inventory more likely than they may have previously. I think the other piece of that is having a really good in-time inventory supplier. So, making sure that you have a supplier that can ship your medications overnight when you need them so your patients aren't waiting; so that you don't have any out-of-stock medications, and just making sure that you really manage your inventory, maybe much more closely than you would maybe think you would have to bet the reference product.

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses how specialty pharmacists manage inventory, storage, and handling of biosimilars. 

Dr Fran Gregory Discusses the Unique Requirements for Handling Biosimilars

Knowing that a specific biosimilar will produce the same clinically signficant response as the branded medication is key to ensuring comfortabiltiy among patients and providers, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health. 

How can healthcare providers, pharmacists, and payers collaborate to ensure that patients have access to high-quality biosimilars and make informed decisions about their use in their treatment plans?

I think a lot of that goes back to educating the entire line of stakeholders, from the providers, from the pharmacists to the nurses administering it, the technicians in the pharmacy, all the way to the patient and their caregivers. Making sure that all those stakeholders are confident that this medication is clinically the same product, that they're going to have the same clinical benefits, they're not going to have different adverse events, they’re not going to develop immunogenicity. Creating confidence and a comfort level across every single one of those stakeholders is really a key piece to making sure that patients get access to these medications.

There have been a number of surveys where it is found that most providers are willing to prescribe a biosimilar. I think about 70% of patients say they would be happy to take a biosimilar if their health care providers reassured them with confidence that it was the same product, and they would get the same clinical response. So, it's really that reassuring of the patient that this is a good thing to do and, ultimately, will save the US health care system dollars and, hopefully, it will also save the patient money as well.

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses the importance of collaboration between all stakeholders to boost confidence in providing patients with a biosimilar drug. 



Dr Fran Gregory: Providing Patients With High-Quality Biosimilars Is a Collaborative Effort 

Although a "generic-like" model may be preferable to stakeholders, the United States has a long way to go to get the biosimilars market to reach that point, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, at Asembia 2023.

Will the biosimilars space evolve into a more "generic-like" marketplace or will beiosimilars behave more like reference products?

Yeah, that's a really good question too! Right now, we are seeing biosimilars behave a little bit more like reference products. We're seeing them being treated differently on formularies. We're seeing them come to market with slight variations.

The adalimumab biosimilars are a great example of why they're not exactly like generics. There's variability in biologics in general. So, of course, there's variability in biosimilars. Not only is there innate variability, there's also some slight differences in some of the makeup of these products.

For example, with adalimumab, we have citrate-containing and we have citrate-free, we have high-concentration, we have low-concentration, we have different administrative devices that patients might view as better than others. So, there are a few things that are different about biosimilars and biologics in general that aren't present when we think about simple molecule generics that are all exactly the same.

While we would like biosimilars to look more like generics eventually, there are several things that we kind of have to evolve to get to that place.

I think that the FDA designation for interchangeable biosimilars is, to many people, confusing and somewhat unnecessary. And, we always hear it said that interchangeability of a biosimilar is a regulatory concern, not a clinical concern.

The fact of being approved by the FDA as a biosimilar in every other country in the world means it's an interchangeable biosimilar and it can be substituted for a reference product.

The United States is not there yet, on that piece as well. While I would love to say we're ready to really have a generic like model—I think that would be so much easier for all stakeholders—we're just not quite there in the US yet. There would have to be a lot of changes to policy, a lot of changes to the FDA approval processes and pathways, and we have a long way to go in that regard.

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses what the future biosimilars marketplace may look like compared with generics and reference products at Asembia 2023.

Dr Fran Gregory Discusses the Future Landscape of the Biosimilars Marketplace

Continuing research and education awareness of the efficacy and safety of biosimilars is necessary in the United States, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health.

What lessons can specialty pharmacists learn from other countries' experiences with increasing adoption and trust in biosimilars for Humira (adalimumab) and Stelara (ustekinumab)? 

The United States is without any doubt somewhat behind other countries in the uptake and the acceptance of biosimilars. We all know that tender systems are much more effective in converting products close to 100% to a biosimilar, and this has been done in many European countries, and there are many studies representing the success of those programs. 

When we think about the US system, obviously, we talked about rebates, we talked about formularies, we talked about incentives that aren't necessarily always aligned to the lowest-cost option for patients. If we think about what we can learn from other countries, it really is thinking again about that big picture, what are we trying to accomplish here. As health care providers and as a country, we're trying to get to improve patient access and a lower-cost alternative for a patient. Other countries have been very successful at that.

The other thing that I think about when I think about what we can learn from other countries; Hillel Cohen [PhD, executive director of scientific affairs at Sandoz,] recently did a really nice study of all of the biosimilar-to-biosimilar switching publications and analyses out there. He wanted to evaluate the biosimilar-to-biosimilar switching and is it safe; is it effective? Are there additional safety concerns or immunogenicity concerns, other things we need to be worried about when we start thinking about biosimilar-to-biosimilar switching?

A very high number of patients have experienced biosimilar-to-biosimilar switching, and this is a result of either a formulary change or a change in tender selection for certain countries that have a tender system. Those patients had experienced no greater adverse events, the same efficacy, and no change in immunogenicity from either the reference product or a biosimilar-to-biosimilar switching.

I thought that was interesting learning from again, mostly European countries, who have tender systems where they do convert patients very, very effectively. And that is a concern still in the US that we hear: Is it safe to change from one biosimilar to another? And pharmacists do think about that. We think about the safety of our patients, and we want to make sure that they get the best treatment that's most appropriate for them.

I think that we have in the biosimilar world people who study these things and trust the science and the real-world evidence that biosimilar-to-biosimilar switching is not a concern. But that is another myth that we'll have to get kind of over in the United States and make sure that we continue to educate and reassure pharmacists, physicians, all health care providers, and patients that biosimilars are a very safe, cost-effective option for a reference product.

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses how the use of biosimilars in other countries strengthens the acceptance and approval of these products in the United States. 

Dr Fran Gregory: What Can We Learn From Biosimilar Use in Other Countries? 

was originally published on AJMC.com, the sister site of The Center for Biosimilars®.

At this year’s Community Oncology Alliance (COA) conference, Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, sat down with 

®) to discuss the use of biosimilars in oncology care and the impact of pharmacy benefit managers (PBMs) and payers in this market.

At the meeting a year ago, we were hearing that PBMs were making it difficult for practices to use biosimilars or to use the biosimilars of their choice. Can you compare the situation today to a year ago? How is COA advocating for practices in this area?

 It wasn't just PBMs. I want to be very clear—it's PBMs as well as payers. And what they have done is they've taken that biosimilar market, and through our original COA data set that we did a year and a half ago looking at the first 2 years (2018 to 2020) of biosimilars, we showed that when biosimilars entered the market in the oncology space, that it reduced ASP [average sales price], it reduced the Medicare allowable, and the corollary is it really increased patient care.

There were more administrations to cancer care patients during that time period. There was this massive uptick in the use of biosimilars during that time. But then the payers and the PBMs got wise to this, and they saw an opportunity with biosimilars.

So, you hear stories of larger rebates by the biosimilar manufacturers being given to PBMs and the payers in order to gain access to formulary, because Medicare is the only payer that has open access to the brand as well as all the biosimilars. Past that, most of the commercial carriers as well as the Medicare Advantage plan have limited formulary. So, you may have brand and 1 or 2 biosimilars, [or] you may not have the brand; you just may have a couple of the biosimilars.

And what it's done is it's split the biosimilar space. That forces practices to carry multiple biosimilars based on the patient's individual health care plan. So, it has made it a little more of a challenge. It's not something that we can't handle and operationalize for, but it is a burden. And we don't see that getting better.

What's happened since that 2018 advent is the payers and the PBMs continue to extract those large rebates or request those large rebates from the manufacturers. And what's happened is ASP is essentially eroded for all of these products.

It’s becoming a challenge. We still stocked and provided them to our patients. No one's underwater yet on these products, but it has made it more challenging when you look at the health of the overall biosimilar market to keep it in a healthy state due to the business practices of the PBMs and the insurers.

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