Expert Reflects on Trends, US Market of Biosimilars in 2023

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, discusses the dynamic landscape of the biosimilars market, providing key insights into its current status and future projections. The global biosimilars market, valued at $35 billion in 2022, is poised for a robust 13% compound annual growth rate (CAGR) from 2023 to 2032. Gregory sheds light on the rapid growth observed in biosimilar development, emphasizing therapeutic areas such as oncology supportive care, oncology therapeutic treatment, rheumatology, and the emerging field of ophthalmology.

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Q: What is the current global market size for biosimilars, and how has it evolved in the past year?

Fran Gregory: If you look at biosimilars globally, the market size was worth around $35 billion in 2022, and we expect that to continue to grow. It’s kind of really taking hold of the market. Currently, we're seeing a lot of movement recently, and we expect that growth to really continue at around 13% [compound annual growth rate (CAGR)] from 2023 to 2032. So that's the annualized growth rate that we expect to continue to see, so definitely continued excitement in this space, a lot of attention in this space regarding the possibilities to see significant savings here.

In addition, the FDA reported as of December of 2022, that there are over 100 biosimilars in development. That is just looking at kind of the US market and what we're seeing from the FDA regarding biosimilar applicants that are currently working on developing products. It’s definitely taken a lot of time for this market to kind of develop, the Biologics Price Competition and Innovation Act of 2009 was the first time that we really had a regulatory body to a regulatory pathway to see these biosimilar medications come to market. Right now, we have over 40 approved in the US by the FDA. So really exciting time and we're going to continue to see that those numbers increase as we look towards the next few years.

Q: Which therapeutic areas have seen the most growth in biosimilar development?

Fran Gregory: I think we're all very familiar with the first biosimilars launching in the oncology supportive care space. We're still seeing very, very good market share and good reception of those biosimilars in the supportive care oncology space. We also have seen a lot of very rapid uptake of biosimilars in the oncology therapeutic treatment space. With Rituxan, Herceptin, and Avastin coming to market over the past few years, those really took foothold very much more quickly than some of those earlier biosimilars did. So that's been really nice to see, and all of those products have market shares anywhere from 70% to 85%. Again, those reach those high market share percentages much more quickly than we saw with some of those earlier supportive care products.

Rheumatology is kind of the next obvious place where we're seeing a lot of development and a lot of discussion and chatting about. When we look at Remicade biosimilar launches, those have been around for a number of years now and unfortunately, we did see a relatively slow uptake of those biosimilars in that space. We now have the Humira biosimilars, or the adalimumab product launches, that have been obviously quite a hot topic over the last 9 to 10 months. We have a number of biosimilars in this space, and we're already seeing a decent market share, maybe even more than we expected in that adalimumab pharmacy benefit biosimilar [(PBM)] space, we expect to see that continue to develop as some of the Humira biosimilar contracts with payers and PBM to expire or kind of run down towards the end of their lifespan, we'll see more of the biosimilars being preferred on formularies. We'll continue to see uptake in that space as well.

Then finally, of course, the interesting area that we've seen lately, no growth in this area yet, but just kind of a highlight in the Stelara approval, the first Stelara biosimilar as of October 31 of this year, so we do expect to see some action in that space in the next year or so as well. I guess I'll highlight the retina space Avastin is an oncology/retina product, and we certainly see high utilization of Avastin in the ophthalmology space. We're also experiencing a lot of growth with Lucentis, especially recently, not sure if payer PBMs have kind of helped push those along, but we're certainly seeing some uptick and in Lucentis biosimilars and then we're expecting, Eylea. Although there's some litigation around Eylea, currently, a lot of unknowns. We do expect to see Eylea products in the retina space launching here in the near term as well. A lot of action, a lot of things to talk about, and a lot of really good news in the biosimilar space right now.

Q: What changes or updates have occurred in the regulatory framework for biosimilars in the US market in 2023?

Fran Gregory: There have been some interesting things I can't say huge changes from the regulatory perspective but some interesting things kind of coming forward. I think probably the biggest one that is most notable that a lot of people are hearing about is the interchangeability arguments. There have been a couple of bills raised recently, probably one of the most talked about was the Biosimilar Red Tape Elimination Act, which was raised by Senator Mike Lee of Utah, in November of 2022. The goal of that bill that was raised was really to modify the 351k approval pathway language regarding interchangeability, and really making that interchangeability not as much of an emphasis throughout all biosimilar approval processes. That bill actually followed HR8877 in September of 2022, which was cited as the Biologics Competition Act of 2022, and it aimed to highlight the differences between how biologics are deemed interchangeable in the US and some of the other drugs that are approved in the US that are not biologics and why are those so different. It is a lot of interesting activity regarding the need, or maybe not so much the need, for the interchangeability designation. However, unfortunately, these bills haven't really gone anywhere, as far as moving along the process in any kind of significant way. We're not really seeing those being enacted currently.

Just to make it clear, I know a lot of our listeners are very familiar with biosimilars. Some are not. I think that one of the most important things when you think about biosimilar interchangeability that is strictly a regulatory term. It is not a clinical term; it is not a safety or an efficacy term. It really is strictly a regulatory term that only exist in the US. Any other country who uses or approves biosimilars, which there are many, none of them have this interchangeability designation and an biosimilar is essentially by being a biosimilar kind of automatically receives that interchangeability designation. Of course, I'm speaking out of formal legal terminology here. Essentially, that's the translation of the interchangeability designation outside of the US it really doesn't exist. It does create some barriers that obviously many, many support from even a bipartisan perspective. This is very, very supportive that maybe we're creating additional costs and challenges in the biosimilar pathway that possibly aren't necessary.

The other thing that's interesting, of course, we're all aware of the Inflation Reduction Act, the insulin cost cap of $35 per month that Biden put into motion. I think that that has impacted the biosimilars in the insulin space quite a bit. We don't see as much of a market share uptake in the biosimilar insulin space as what maybe we would have expected or thought because this kind of eliminates a lot of the need for cost competition in the biosimilar insulin space. I think that's been an interesting development. We’ve kind of wondered how that would impact the insulin market overall, not just as it applies to biosimilars, but it certainly has. It certainly has made that insulin market a little bit more challenging for biosimilar manufacturers.

Then finally, interestingly, this is a little tidbit. But in September of 2023, the Federal Register Notice from the Federal Register, the FDA actually took the interchangeability language out of biosimilar prescribing information requirements. So potentially that could minimize the concern with the interchangeability or even the notice that interchangeability exists for certain products and not others. I think there are a few things that are happening that could be seen as positive or at least certainly highlighting some of the challenges and trying to remove some of those barriers that we see in the US.

Q: What strategies are being employed to increase the adoption of biosimilars among health care providers?

Fran Gregory: I think some of the strategies that really are important, it's very basic, but education. When I think about biosimilars, again, some people are very bought into biosimilars early adopters, very well educated. I think we see that among most oncology health care providers currently. They know their biosimilars, they know the products, they know the prices, they know the reimbursement rates, they understand the market, and they're very well versed in in biosimilar. I feel like oncology kind of has set the stage for the rest of the market to develop. But in some of these newly emerging areas, we don't see that type of education and that type of knowledge and that type of competence yet. Specifically in the immunology rheumatology space where we're seeing very, very, very aggressive changes being made and, formulary payer PBM space and providers need to be educated to be able to kind of keep up with those rapid changes. I think that that's one of the key things that we try to provide at Cardinal Health is just biosimilars are here. There are some changes going on that are going to impact your practice, and we want to make sure that you understand what it is that is coming your way, so that you can manage that to the best of your ability so that you can understand what it is and what we're talking about. When patients ask questions, you can answer those with confidence. Also, helping you understand which products are preferred for which patient, which payer, which PBM, so that you can avoid some of that administrative burden when prescribing maybe the reference product when it might not be a preferred product anymore, or one of the biosimilars that's not necessarily one of the preferred, or chosen biosimilars from that particular PBM repayer. We're really just trying to make sure that the market is educated because it is a rapidly changing environment. It can be confusing when you're looking at 10 different products for 1 reference product that you were pretty comfortable with previously. It can be a challenge for health care providers. We're really working on just providing that education, and I think it's key for everyone to continue to educate each other on biosimilars, not only the clinical value, the safety and efficacy, the clinical trials that these products are required to go through in order to be approved by the FDA, and the fact that they have to prove that there are no clinically meaningful differences between their product and the reference product, just instilling that confidence that these products are highly similar to the reference products and the clinical outcomes have been proven to be the same. We really want to continue to reiterate that message so that that comfort level can be instilled in all health care providers, pharmacists, nurses, physicians, etc. so that the patients can feel confident taking these medications as well.