Episode 48 – New and Noteworthy Biosimilars

Mike Stull (0:09)

Hi everyone, and welcome to HR Benecast, your source for expert commentary and insights on current health benefits related news and strategies. This is your host, Mike Stul. Here at Employers Health, we always strive to provide useful content and resources you and your colleagues can use to stay informed on the latest in employee and pharmacy benefits.

Last year, we hosted over 25 webinars discussing industry hot topics, all of which are available on demand at employershealthco.com forward slash events. I encourage you to watch any of them that you may have missed and share them with your team.

Lastly, I want to invite you to our 2025 Annual Benefits Forum on April 22nd and 23rd in Columbus, Ohio. You can read more about this exciting two-day event and register on our website at employershealthco.com/abf25. Again, employershealthco.com/abf25.

We have a great lineup of benefits professionals, including today’s guest, Jeff Casberg.

Jeff is Vice President of Clinical Pharmacy at IPD Analytics. He is responsible for the development of drug and drug class management strategies for managed care, health systems, and pharmaceutical manufacturers with a focus on drug loss of exclusivity and biosimilar launches. I hope you enjoy my conversation with Jeff.

Welcome, Jeff, to start us out today. How about giving the audience a little bit of background about yourself?

Jeff Casberg (1:56)

Sure, Mike. Thank you. Jeff Casberg.

I’m a pharmacist, University of Connecticut graduate, and been a pharmacist for, gosh, I’m going to say 40 years. Did a little bit in everywhere in pharmacy, retail, hospital, home infusion, PBMs, health plans, and now I’m with a company called IPD Analytics. We provide drug management strategy and drug intelligence to pretty much everybody in the pharmaceutical industry who consumes information about drug management.

Mike Stull (2:33)

Excellent. I know we subscribed to IPD, and even as a lay person, I find the information very useful in my day-to-day discussions, so thank you for that. We wanted to talk a little bit or maybe a lot about biosimilars today, and I know the first area we wanted to touch on was around why there tends to be maybe confusion around when does a biosimilar actually launch, and we know that a lot of those dates are determined by the settlements, and so the first question is why are there settlements and court cases in the first place?

Jeff Casberg (3:22)

Sure, and just to start us off, settlement agreement. I’m a pharmacist, and I joined IPD about 10 years ago, and I thought I knew a lot about pharmacy, but I remember the first day I walked into the building for our company, and we have about 10 intellectual property attorneys on staff, and they started talking to me about the legalities around pharmaceuticals, and one thing that came up were settlement agreements. So a drug is approved by the FDA, and during that approval process, the US Patent Office issues patents, and patents allow a company to market a drug for a period of years without competition, and then at the end of that competition, there’s opportunity for either generic or biosimilar manufacturers, depending on the molecule, to launch their competing products, and you would think that would be fairly simple. There’s a date, but the patents, there isn’t just one patent on a drug. I didn’t actually understand that until I came to IPD.

There can be 10 to 100 patents on a drug. So what happens is the generic and biosimilar manufacturers look at all the patents, and the brand manufacturer who markets the branded product looks at their portfolio patents, and I guess there are times where it’s pretty clear this is the date, March of 2027, but there’s also many times with all these different patents that it’s not clear because some patents are more important than others, and I’m going to say a couple words here that are kind of more legality. I’ll try to make it simple.

There’s composition of matter patents. There’s method of use patents. There’s dosing patents. There’s formulation patents. There’s manufacturing method patents, and all these kind of boil into what date one of these patents, which could be a strong or a weak patent, expires.

So I guess what I’m trying to say is it’s not black and white many times. It creates some negotiation needed, so that’s when the brand company and one or more generic companies sit in a room or wherever over a Zoom call and negotiate a settlement, and they come upon a date, and for biosimilar company X, they may determine you can launch a biosimilar on this date, and then the next biosimilar company comes in and they negotiate, so it’s not always the same date actually. Different biosimilar manufacturers may have settlement agreements with different dates. That’s kind of what happens with settlement agreements and why there’s ambiguity and unclarity on when biosimilars may launch.

Also, there’s actually these biosimilar manufacturers who may say, oh, I don’t like that agreement, and they may launch at risk. So what happens is they can launch at risk, but what the risk is is that if in the end a court decides, well, no, you launched too soon, and then they sold millions of dollars worth of that biosimilar product, the biosimilar manufacturer may owe back payment to the brand company. So there’s a lot more in the legal side of pharmacy than most people realize.

Mike Stull (7:02)

Yeah, and it doesn’t seem like any of the drug legislation out there that tries to tackle the prices of medications really get into this concept of patent reform. So thank you for walking us through that piece of it, because certainly I think there’s a lot of individuals that don’t even have a macro-level view of how the patent system works. We talked a little bit about dates and the confusion around or the uncertainty around dates.

How about from a price perspective? What are we seeing in terms of the prices that these launch at?

Jeff Casberg (7:49)

Sure, and that’s a great question for the audience, because most people think about biosimilars like generics, but they are actually more like brands. These biosimilars have brand names. They have sales forces.

So in general, the prices of biosimilars is more like a brand price, and many times they don’t announce the pricing until launch or just prior to launch. We’ve had biosimilars now for about 10 years, but most of them have been on the medical side, and that’s kind of a little bit of a different world, the medical benefit. Humira was really the first pharmacy benefit biosimilar that came out.

There was other products, insulins, et cetera, but that was a little bit of a different world. Humira was the true first real pharmacy benefit biosimilar, and when it launched, I remember everybody was trying to predict, well, what’s the Humira biosimilars going to come out at? I think we were predicting, I don’t know, 20 or 30% off, and I thought that was pretty deep.

They came out at 55%, and I said, wow, 55%, boy, that’s pretty deep. And you know what? We were all wrong.

Then when the follow-on, the next biosimilars came out, they came at 70%, 80%. Now we’re at 90% off. So I think we’re still in the early stages of biosimilars, especially with the pharmacy benefit biosimilars and predicting prices.

It’s still settling out on how biosimilar manufacturers price their products. Generics have been out for 30 or 40 years, and we have a good feeling about predicting generic prices based on the branded product itself, and then how many generic manufacturers enter the market. But because biosimilars are more like brands, I think this whole pricing of biosimilars and launch pricing is still evolving.

Mike Stull (10:04)

So you mentioned Humira, and that was obviously the big news for last year. And as a collective that has a CVS agreement, certainly our clients saw big changes as it relates to the utilization of Humira as a reference product and its biosimilars. So now what are you seeing in terms of uptake across the entire market of the biosimilar versus the originator product?

Jeff Casberg (10:39)

So Humira, yeah, the largest selling pharmaceutical of all time. And I think we’ve seen three phases in the evolution of biosimilar Humira launch. The first was 2023.

We got a biosimilar early on, I think January of 2023. And then a few others straggled in during 2023. But what happened during 2023?

The answer is not much. By the end of the year in 2023, we had only a few percent conversion from branded to biosimilars and everybody was a little bit disappointed. We rolled into 2024.

That would be the second phase. And the first few months were boring again. But later on in the spring, CVS made a move.

They made the first big move in 2024. And we saw about a 20% movement from branded to biosimilar Humira. And that stayed steady for the rest of 2024.

There was a few other modest or minor launches during that period after CVS made theirs, but that was the biggie. But now we’re in 2025. And I call that phase three.

And I think we are starting to see movement. To be truthful, Employers Health right now may be getting the first news that I’ve broke on this. So this podcast here forced me to kind of break into the data.

So I looked at the data over the last few days and it’s not real clear. Usually pharmaceutical utilization data is fairly clean information. But when you look at utilization on biosimilars, we don’t feel the data is complete.

So, some of the numbers here, I’m just going to give you rough numbers, but let’s just say we ended in 2024 around 20, 25%. I think the numbers are showing some change. I think we’re starting to see that we might be at 30% or potentially even 40% right now.

It’s hard to say the data is not real clear, but we’ve definitely seen some moved. Could the numbers reach 50% here in the next couple of months? I would say yes.

So I think we’re starting to see some movement on Humira biosimilar. And realistically, what this takes is for the PBM or the payer to actually move the branded product off their formulary. You don’t see much movement until you see that happening.

So for 2025, both Express Script and CVS removed Humira from their commercial formularies. So no more branded AbbVie product on the commercial ESI and CVS formularies. Optum, the third big player did similar, maybe not quite as strong.

I think they still have branded AbbVie, Humira on some of their formularies. So overall, I think 2025, you’re going to see some pretty big movement. And I think one thing I forgot to say in 2024, in that second phase was a whole new phenomenon.

We had never seen private label biosimilars from the PBMs until early in 2024. CVS has their GPO called Cordavis. They introduced their private label, SanDose Cordavis product.

ESI has a company called Qualent, their GPO. They’ve lined up with Teva and Bowringer on their Humira biosimilars. And then lastly, Optum, the United Healthcare PBM has a company called Nuvelia and they’ve lined up with Amgen.

So these private label products is kind of a new phenomenon in biosimilar. And we’ll probably start to see that with another product still are coming up as well.

Mike Stull (14:46)

Yeah, I think the private label biosimilars are certainly an interesting phenomenon and we’ll see how long this trend lasts. For the audience, I think it’s good to know since we talked a little bit about pricing that even these private label biosimilars are priced differently depending on the PBM. So for example, Express Scripts has its biosimilar around 46% off, whereas the CVS and Optum biosimilars for Humira have around an 80, 81, 85% discount.

So there are certainly some pricing maneuvers. I’ll use that word as a way to be nice. There are certainly some maneuvers out there that are being done.

Speaking of price, one of the big pieces that determines whether or not plans and participants see savings is what the rebate on Humira look like in the first place. And so I guess the question that we get a lot from clients and consultants and others is, what kind of net savings are we actually seeing in the market?

Jeff Casberg (16:12)

Yeah, now that’s the most important thing. I mean, we wouldn’t be switching products unless we saw savings with equivalent efficacy. So for biosimilar Humira at the time of biosimilar launch, the rebates, let’s use a round number of about a 30% rebate.

So employers, payers were getting a 30% saving on the branded product at that point. So now what are we getting? So currently let’s just use a number that Humira brand is giving about a 65% savings.

So, they’ve upped their rebate from 30 to 65. And then the biosimilars are, let’s use a round number of 80% off. So you’re seeing about a 50% savings if you stayed with Humira.

Let’s just say you never moved a single person from branded to biosimilar, just because of the increased savings on the branded product that at V is giving, you’re saving about an extra 50%. But then if you’re switching to the biosimilars, you’re saving even more. So you’re probably saving about 80%.

So those numbers sound pretty big, but measuring those savings is a different story. There’s rebate guarantees, there’s coupon programs, there’s things that make that calculation of exactly what you’re saving with biosimilars, not straightforward. So the answer is definitely yes.

And then how you can calculate that, you have to look at your numbers themselves, but we had a similar problem with generics on calculating generic savings. Overall though, I think biosimilars without a doubt are saving us money, whether you’re going with the branded rebates or the biosimilars. Of course, I’m a fan of moving people to the biosimilars, but I would say you’re definitely saving at a minimum of 50%, you’re probably saving 60, 70, 80% when you convert somebody from a branded product to a biosimilar product with Humira.

Mike Stull (18:37)

Yeah, we would certainly agree with that sentiment. And I think that a lot of our clients would agree that they would rather take the low list price biosimilar upfront than pay full price and wait 90 to 180 days to get a big rebate check. And certainly from a patient perspective, I think most specialty patients are on some type of copay program now.

So I know for 80% plus of our clients, those patients are paying $0 out of pocket today. So the patients may not see a huge advantage upfront, but certainly the plans would. Do you think that, or are you seeing much difference in terms of the pricing once the biosimilars are launched?

So, if a biosimilar is launched at 80% off, should we expect to see that continue to come down or do they stay pretty constant or is it just too early to tell?

Jeff Casberg (19:44)

Yeah, great question. So, we’re starting, right now we’re seeing in general, the list price of these biosimilars at 80 to 85% off. What actually is the net price is variable because we don’t see the premium and payer confidential net price after rebate.

So biosimilars have these high net discounts just off list price, but biosimilars actually have many times, not always, but many times have rebates on top of that. So we don’t know the net net. I would say if you’re going to compare PBMA to PBMB, whoever’s negotiating those deals, there may be a few percent difference.

But overall, I would say most of the big PBMs are within a range of each other. The real differentiating factor on savings here is not so much if you’re getting 82 or 83 or 85% off. The real savings gets to how many patients are you converting?

So, I wouldn’t sweat too much if you’re using product A or product B or product C and there’s a little difference in net price. I think the real thing will be the success in converting patients from the brands to the biosimilars. That’s really where the rubber meets the road.

But to get back to your first question, I think in 2025, the PBMs did negotiate deeper discounts. So I think moving between 24 and 25, we probably saw a few percent savings compared to 24. I think you are getting a better deal in 25.

Mike Stull (21:33)

Yeah, great point on the ability to move utilization because those discounts mean nothing if you can’t get patients to switch. And certainly, we hear a lot of noise about certain pharmacies out there selling highly discounted biosimilars and, oh, everybody should move to this. Well, if it’s in the case of Humira, if it’s not the higher dose and you can’t move as many patients to it, then what good is that really deep discount?

So let’s switch gears and go to 2025. And we’ve touched on Stelara. Obviously, it’s the big one that we’re watching this year.

Any early signals in terms of adoption so far?

Jeff Casberg (22:23)

Sure. Very early. So, looking at a calendar here, Amgen launched at the first of the year, 1-1-25.

But interestingly enough, Amgen only signed on with Optum, Nuvelia only with Stelara. So starting in January, really not everybody had access to Stelara biosimilars, only Optum patients. And we’re not really seeing a lot of pickup right now.

So you move from 1-1-25 into late February, early March. So, if you look at that, we’re only a few weeks into the true launch of Stelara biosimilar. So, we had five launches, late February, early March, Teva, Celtrion, Samsung/Sandos, Biocon, Fresenius Cabi, but haven’t seen a whole lot of big announcements to date.

I think what we’re going to see is not exactly the same path as what happened with Humira, not the completely boring 2023. I think we’re going to see 2025 with some movement. But until these formularies change, and people actually take Stelara brand off and put only Stelara biosimilar on, you won’t see wholesale movement.

So you will see something here in 2025, I’ll predict better than what we saw with Humira in the first year, but 2026 will probably be the big one. So which actually moves the whole thing up a year. So it took really till now with Humira, which is the third year, I think you likely see the big moves, some move in the first year and the big moves in the second year for Stelara.

Mike Stull (24:08)

You talked about the big change that groups need is to exclude the originator product from its formulary. And certainly for our clients, we’ve definitely seen that where in the case where we’ve excluded an originator product, you’ll see 95, 96, 97% movement to the biosimilar, which has been fantastic. And then others where it’s a co-preferred position, and we were lucky to get 15, 20%.

So certainly its formulary positioning plays a huge role in adoption. How about pricing for Stelara biosimilar? So, I think the news last week that I saw on my LinkedIn feed was that Navidus had inked a deal with Teva for a biosimilar, looking to be about 96% cheaper than Stelara.

Others I’ve seen around 80 to 85%.

Jeff Casberg (25:13)

That 96 is a big number. I don’t know if I believe that number. Maybe Employer’s Health will get that because with your leverage.

But what I may have seen is it’s a little different with Stelara. One thing with Humera was almost everybody had the high and low WACC to offering. So what we’re seeing now with I think seven or eight approvals and six or so launches, only Amgen, the very first launch has the high low WACC.

We’re not sure that. I’ve heard some rumors about that it just wasn’t worth it. It was costing money to do two product launches, and they weren’t using it.

So I think right now we’re seeing everybody with the deeper discounts, the low WACC product only. There were some rumors that could have been some settlement agreement impacts with J&J that has caused only one launch, but we are only seeing Stelara’s with one launch in the ranges of discounts are pretty tight and higher than we saw with Humera to even start. Amgen started with their high and low at a low high WACC of 5% off and a low of 81.

And then everybody else is in this 86, 80, 90 range. So basically 80 to 90% off, which is even a little deeper than we saw with Humera. So you’re going to see some big savings here with Stelara once you get those patients converted in whichever biosimilar you choose, you’ll get some savings there.

Mike Stull (26:59)

Excellent. So just to round us out here, we’ve talked about Humera and Stelara, but what other biosimilar launches are you all watching there at IPD?

Jeff Casberg (27:13)

There’s a bunch coming, the big ones for 2025, 2026, ILEA, a medical benefit product for age-related macular degeneration. It’s an eye injection, not so much on the commercial side, but it’s a big drug. They’re going to have about nine biosimilars out.

Prolea, a drug for osteoporosis and oncology, about a $6 billion drug. We’re looking for potentially 15 biosimilars lined up. So Prolea, ILEA, Zolares had their first approval, an asthma and inflammation drug.

So those are some of the other big ones, a few other names, Orencia, Sympony, and even we had our first Novolog fast-acting insulin biosimilar just approved in launch. So there are a few other ones here in 2025 and 2026, overall some big saving potentials.

Mike Stull (28:12)

Excellent. Well, Jeff, certainly appreciate you coming on the podcast and sharing your insights into the marketplace as it is today and what you see coming down the line. And we look forward to having you at our annual benefits forum here in another month.

Jeff Casberg (28:34)

Mike, thank you very much.

Mike Stull (28:36)

Thanks again to Jeff. If you want to hear more from him, he’ll be presenting, The Impact of New Drugs and Therapies on PBM Spend, at our 2025 annual benefits forum.

Again, you can learn more and register at employershealthco.com/ABF25.

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