Expert Discusses Anticipated Trends in Biosimilar Market for 2024

Fran Gregory, PharmD, MBA, senior vice president of emerging therapies at Cardinal Health, shares valuable insights into the anticipated trends, challenges, and untapped opportunities in the biosimilars market for 2024 and beyond. The biosimilars landscape is set to witness significant growth, particularly in therapeutic areas like ophthalmology and immunology, with a focus on blockbuster biologics like Humira, Stelara, and Eylea.

Q: What are the anticipated trends in the biosimilars market for 2024 and beyond?

Fran Gregory: I think that we've learned from watching the Humira launches that launches moving forward where there's a significant financial value for the biosimilar manufacturers. For example, some of these hugely, blockbuster biologics like Humira, like Stelara, like Eylea. They're going to be very competitive as far as the number of biosimilars available for these reference products. When you look at Humira, I know, it's been said many times here, that's the highest sales drug in the world, right? It has the highest revenue sales dollar amount in the world, I think $28 billion is the last number that I saw annually for that product alone. So clearly a huge opportunity, not only for US health care savings, but global savings.

Then also an opportunity for biosimilar manufacturers to really capture some of this market and kind of spread that wealth throughout some competitive players. I think that's definitely a good thing, and when we look at the pipeline, we can certainly see a very large number of biosimilar manufacturers developing products for some of those other blockbuster types of products. If we look at, again I mentioned Eylea. These are all estimates, and they could change tomorrow. We know this market changes rapidly, but for Eylea, they're around 10 biosimilars in development. We have a couple of well around 8 for Stelara, a number for Prolia and Xgeva. Those are the same product, just 2 different brand names. Humira, again, we have so many now, that it's difficult to keep track of because of the fact that we have branded biosimilars, we have unbranded biosimilars, we have high [weighted average cost of capital (WACC)], low WACC, we have high concentration, low concentration, but we have a very, very crowded market in Humira space, which can be very confusing to health care providers.

Also, again, looking at the bright side offers a very significant amount of competition in this space, and we're certainly seeing some price tags that are reflective of the competition. I think we'll see, again, the trends being high numbers of biosimilars creating that competitive market within each reference product, and then we'll also, I don't know if it's unfortunately or fortunately, but I think we'll continue to see these pricing tactics that are kind of providing optionality, which is the bright side of that. It definitely provides optionality for a provider or a payer [pharmacy benefit mangers (PBMs)] regarding, high WACC or low WACC and whether you're looking for a rebate or the lowest net cost, exactly what is attractive to the payer or the purchaser. I think we'll continue to see some of those trends as well. Then the other trend, I think we'll see is just continued biosimilars entering the pipeline in some of these blockbuster products that will be going off patent in the next 5 to 10 years.

Q: Are there still any challenges in overcoming misconceptions or reservations surrounding biosimilar usage?

Fran Gregory: I think there's a different approach when we think about medical benefit biosimilars and pharmacy benefit biosimilars. When we think about a physician who is practicing and who is familiar with or comfortable with prescribing a certain medication that is infused in the office, and there's a certain reimbursement rates that they're comfortable with, and there's a certain financial picture that they're comfortable with and familiar with, and then that changes with a biosimilar entry. I think that can be challenging as well. The reimbursement rates of [average sales price (ASP)] plus 8% versus ASP plus 6% for biosimilars as long as that biosimilar’s ASP is below that of the reference product. I think that is helpful for some of these providers, but it's also educating them that that even exists. You will be reimbursed, at an additional rate, and that rate is based on the ASP of the reference product. So you will be reimbursed a little bit more for at least a period of time. I think reimbursement is a big thing that needs to be continued. We need to continue to educate providers on.

Then also thinking about the pharmacy benefit biosimilars. Again, understanding what are the preferred products for what patient at what point in time. Providing physicians and providers with the tools and the resources to make educated decisions for their patients and for their office and for their facility. All of the financials kind of have to work out for everyone to win here. It's definitely an area that that deserves more attention and more focus as we move forward, but I do think that oncology, again, is an area that really has this down to quite a science and has accepted and adopted biosimilars pretty readily. We've seen that with the most recent launches in that space. So really hope to continue to share information and best practices from oncologists and oncology providers with other providers who are kind of just starting out in the biosimilar space, whether it be on the medical benefit or the pharmacy benefit where they're sending the patient to receive their medication from a specialty pharmacy or elsewhere. It's kind of a different ballgame, depending on what line of business that we're talking about.

Q: Are there specific therapeutic classes or regions expected to experience significant growth?

Fran Gregory: I think 2024 is going to be a really exciting area for the retinas space. We talked a little bit about Avastin. That product has been around for some time with biosimilar. I think we'll continue to see growth there. We also have Lucentis; there are a couple of products approved in the Lucentis biosimilar space that are really starting to see some significant uptake. This didn't happen quite as quickly as what some of us expected, but I do think we see a very significant uptake in the last few months with market shares increasing and physicians may be becoming more comfortable with the idea of biosimilars in the retina treatment space. Then I also mentioned Eylea with at least 10 biosimilars being developed or in development for Eylea. We expect those products, and again, there's litigation ongoing, but we do expect those products to be coming to market early in 2024 [or] mid-2024.

I think we'll see a lot of a lot of payers PBM influence in this space, we've always seen that in this space. I think we'll continue to see that. So it'll be interesting to see how payers and PBMs view the biosimilars and what the pricing structures end up kind of looking like and where we see that going, but that's an area of quite a bit of focus for us is to make sure that ophthalmology specialists in the retina space, really understand what biosimilars are the value, the safety, the efficacy, exactly what we talked about previously, and just making sure that they're comfortable because again, they are coming their way, what our role is just to make sure that the education is there, the understanding, and what it is that's coming your way, who's covering what products, what is preferred, where, and really just helping that decision making process to make it easier for providers to understand not only what's going on, but how to, again, reduce administrative burden and understanding what patient kind of qualifies for which medication at what point in time. A lot of moving pieces, but I think we'll continue to see that space evolve.

Then, of course, we will continue to see immunology, rheumatology grow HUMIRA is just starting out, I think we'll really start to see some movement and market share in 2024 and beyond. We have some other products that are really kind of a little bit unknown as far as when they will actually launch, but as far as products and development that may face litigation may be delayed. We, again, no crystal ball here, but we do know that there's the Neulasta Onpro biosimilar with a device that will mirror the Neulasta Onpro for patients who want to have that administration occur in their home versus in the office, so that's been an interesting development there.

We also have Actemra biosimilar, Symphony, Tysabri in the [multiple sclerosis] space which I think is really exciting. We don't have any biosimilars really for multiple sclerosis currently, so it'll be interesting to see that one continue to develop. If you look out just a little bit further into 2025, and beyond, some of these really exciting medications for, again, oncology, Keytruda, Perjeta. Those are medications that are extremely valuable to patients, extremely high spend for the health care system. I think those can really deliver a lot of value and a lot of savings when those come to market as well. A lot of excitement, I could go on and on a lot of exciting products in the pipeline again, am I won't list all 100, I promise, but definitely a lot of exciting products in the pipeline and certainly room for additional savings to the US healthcare system over time.

Q: Are there untapped opportunities or unmet needs in the biosimilars market that could shape its future trajectory?

Fran Gregory: I think we kind of already mentioned most of these, if I think about the challenges and biosimilars coming to market, litigation is always a challenge patent litigation and evaluating, how many patents these manufacturers have and which ones can be upheld versus not, and, whether they're approved by the FDA or not, when they will be able to launch based on the patent dance and the litigation process that is a standard process that we experience with biosimilar launches. I think that will continue to be an area we'll be keeping our eye on.

The second one being, as biosimilars come to market in new therapeutic areas, just making sure that we are continuing to educate where we can and help providers understand what's coming their way, helping them understand payer PBM coverage and medical policy coverage, and any reimbursement changes that come down the pipe, either from the federal government or manufacturers helping them understand those changes and as that space evolves. Then thirdly, I think, as we think about movement from medical benefit biosimilars over to pharmacy benefit biosimilars, I think pharmacists can play an even more important role. Pharmacists are really the face to the patient when it comes to pharmacy benefit medications. So, I think making sure that pharmacists are playing an active role in not only knowing biosimilars understanding the value, being able to educate patients, which I think we're experts on as pharmacists, that's our job, but also knowing that they can play an active role in some of the health care policy decisions that are being made and some of the decisions that are being made even in their state.

Being a pharmacist, you have the ability to impact what your state requires regarding biosimilar. I think that's another thing I would just encourage pharmacists to be very active with their State Board of Pharmacy and help to shape what they want that that policy to look like and what they want this regulatory environment to look like for biosimilars. I think we have a lot of opportunity to continue to build and shape this market and I think that we all know that biosimilar savings opportunities are so significant and so very much needed for the US health care system. I believe that we'll continue to push forward and see those savings and continue to help other health care providers provide that level of support for patients to feel very comfortable with these medications moving forward.