Biosimilar Series: Part 2

In this episode, the second of our biosimilar education series, Kathy Oubre, CEO of Pontchartrain Cancer Center, and Neil Udovich, Vice President of Sales for AmerisourceBergen Specialty GPOs, discuss the history of biosimilars, the reception of them in the medical community and their road ahead.

If you have any questions for today’s guests, or have a topic you would like to hear more about, email OnCall@cencora.com.

Transcript

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[00:00:00] Neil: Hey Kathy. Good afternoon. Again, I'm excited to talk to you again about, biosimilars. So my first question today is, you know, what is the history of biosimilars? When were they first approved for use in the United States?

[00:00:19] Kathy: So biosimilars, you know, President Obama signed the Biologics Price Competition and Innovation Act back in March of 2010. And what that did was, you know, create a regulatory pathway for biosimilars, but the first biosimilar wasn't available in the U.S. until March of 2015, and that was Zarxio.

But prior to that, they had, they had been, you know, launched and utilized, in the EU for about 10 years prior to the launch of Zarxio. And, you know, some, other things have occurred since that launch of Zarxio back in 2015, you know, there's been continued and enhanced regulations and guidance from the FDA.

And then one of the things that were a little more noteworthy was in 2020, you know, the FDA included biosimilars as part of their purple book database, which I didn't know what that was until I started looking into it. But biosimilars now have a space in this so-called purple book  and what that do, what it is it's a book of all FDA licensed biologics.

And it protects them with exclusivity patent with exclusivity information on those particular products. And then towards the end of 2020, there was the Biological Product Patient Transparency Act, which was signed into law. And you know, what that did is it required the biological reference product to provide the FDA.

Within 30 days of disclosure, the patent lists on, biosimilar applicants and, you know, towards the end of 2020, the FDA, just as a little, you know, nugget, the FDA approved the 29th biosimilar, Reanbi. So, you know, from the launch of 2015 to the end of 2020, and we saw 29 biosimilars enter the us space.

[00:02:40] Neil: That's pretty amazing. Quick path, for these products to come to market. So, thinking back to when the first few were, were introduced, what was the reception from the medical community? 

[00:02:54] Kathy: Well, I think it was lukewarm, Because I think there was just not a comfort level around those products, even though they had been studied in the EU for and used for, you know, a decade prior to, you know, I think physicians had some hesitancy around it.

But again, you know, when, when the peg came to the space, because Zarxio was a Filgrastim product, but when the pegs came to the market, that allowed physicians to really kind of study these products and be comfortable with them. And I think it helped that those were, that was more of a supportive agent than a therapeutic agent, which really kind of primed the pump per se, for when the lab products and those lab biosimilars became available.

And it allowed just that greater sense of comfort because within our organization, and again, community oncology practices across the U.S, when the maps became available, they were implemented very quickly. You know, NCCN did a poster presentation back in Q1 of 21 that said, that the Herceptin bio sims were adopted the most quickly out of any product in the space, at a rate of, I believe it was 57% within a 30 day span. 

[00:04:28] Neil: Yeah. That's pretty amazing. And I'll submit that within our membership at ION, we have an 80% biosimilar market share across all the products which is pretty amazing. And to your point earlier, it wasn't that fast to begin with.

We didn't start out going from zero to 80% it was a slow, a slow March, but at the same time, you know, the comfort level of, of physicians as well as, the benefit to the patient from an economic perspective really helped to drive that uptake pretty quickly

[00:04:59] Kathy: Well, I think so. So, you know, in the peg space, again, that was a product and remains a product that not all of our patients could afford on that day, too, because it is expensive.

And then if you look at the mabs, I mean, those are the three most expensive products that we've been using for, you know, a decade or more. And they're really good products. I mean, I'm old enough now to remember when the Herceptin clinical trials were started. So, you know, these were, these are life changing medications.

And so the idea of, you know, biosimilarity and being able to now, you know, increase access to care through our lower cost product. I mean, that was a win-win and something, again that we saw within our own practice and across the space. 

[00:05:57] Neil: Hey, I'm old. I'm old enough now, too. I was telling about how I remember going to a conference in New York where they were first talking about, anti-angiogenesis inhibitors.

Yeah. It turned out to be bevacizumab Avastin and then a couple months later actually mixing it in clinic oh, some 26 years ago. 

[00:06:18] Kathy: It's crazy. I know you're dating. 

[00:06:20] Neil: Yeah that’s okay. We're only 30 for the listeners. So, what do you think, you know, the biosimilars are now, as you mentioned, have been out for, two, three years how do you categorize their current state?

You know, there's a life cycle and, and a lifespan to all products. So where do they stand today?

[00:06:42] Kathy: Studying the biosimilars over the last year has gotten interesting, especially in the peg space because it's gotten very crowded. And so, you know, it it's all about what the long-term goals are. And hopefully, the long-term goals are a healthy, productive, biosimilar space that will help bring down healthcare costs and, increase access for decades to come.

But you know, we're not quite there yet. We are still new. We are still learning lots of things. Crowded spaces are difficult, you know, and biosimilars are really one of the first times that I've seen the payers really become involved in drug decision making and it's presented some very unique challenges to practices and GPOs and, payers themselves because they've used this, you know, payers have used biosimilars as an opportunity to control their formulary.

So they're approaching these, you know, these pharma partners and saying, you know, you have to essentially bid to be on the formulary and we're going to go one of one, or we're going to, you know, go two of two. And it's presented some very unique business challenges and market challenges that I'm not sure all of us really anticipated.

So, the payers are, kind of splitting the biosimilar market and then you also have different, pharma partners who got into the biosimilar space, for various reasons. And some of them are being good stewards of ASP through their, you know, their pricing methodology and contract design.

But then there are also some manufacturers who are treating these more like generics and pricing them as such. And while that might seem advantageous from a practice perspective, you know, when they're looking at just a simple net cost recovery, it is counter if you're looking at kind of the long game in maintaining that, that healthy biosimilar space for, you know, decades to come.

[00:09:15] Neil: Yeah, certainly reimbursement is a key component you know, because a practice such as yourself, you know, doesn't want to give a drug at a loss to the practice itself. And to your point, competition is fierce amongst all of these various products. And so, they price it and provide rebates from a GPO to drive their market share.

But the consequence of that is to drive down ASP, much more quickly than one would hope. Yes, and so we're at an inflection point in the market from what I'm seeing in the numbers, where it's going to come to a point where practices who have been, quote, loyal to a particular brand or set of brands or portfolio are going to have to make a new decision about what products they use.

But then also to your point, you know, the payers being so heavily involved, how will they, you know, kind of influence those secondary market decisions that you spoke of and that's all yet to be determined. But I'm curious, you know, from your perspective, with all that being said, where do you see biosimilars heading in the future?

[00:10:35] Kathy: I see some of the spaces, narrowing some, I kind of liken it to Darwin. You know, in the peg space, it's crowded. I think you're going to see some that, you know, they may exit the space within the next, you know, couple of years and, and that's okay because it it's so crowded that I don't think you're having.

I think ASP is, is driving down too quickly and too low and you know, practices certainly can't stock products that they're going to take a loss on, you know, that's, that's not good business for the practice in, and ultimately, you know, it's not good for the patient or the market as a whole. So, I do think you'll see the market start to shift around from this.

I do think that, you know, we might see something from CMS and this is kind of segueing, but I think we might see something from CMS, this, you know, this month or next month in regards to kind of an OCM 2.0 or, you know, kind of their next shared savings model. And I'm hopeful that they will address biosimilars specifically within that model.

Because you know, if you really do look at the data around, you know, what it's done to healthcare costs from a large Health national healthcare perspective and patient savings and all these things, you know, it would make sense for CMS to include, biosimilar specifically as part of their next model.

[00:12:21] Neil: Yeah and I had heard, and maybe you can confirm this, but from an OCM perspective, the utilization of biosimilars really drove that cost savings for CMS. So if they were to go away, it would almost really drive healthcare costs back up to potentially above where, where we started.

[00:13:49] Kathy: Oh, absolutely. Because I mean, you know, yes, we need to do everything that we can to continue to support a healthy biosimilar space, but we need to let you know, free market competition you know, continue to play out. And CMS needs to have a hand in that, you know, because you know, Medicare is my second largest payer as is fairly consistent across oncology due to the nature of the age of our patients, you know. You know, we need that support and help for that healthy biosimilar space.

But I do believe in it. I do believe in biosimilars. I do believe that they will be around for a while. You know, the U.S is still in its infancy and there's really a lot more to come. I mean, you know, the retinal specialists have, you know, they just had their first launch of a biosimilar a couple of weeks ago. We're seeing more enter the space for rheumatology, GI, dermatology and you know, although utilization of biosimilars is, is slower and less within those spaces. You know, again, Humira next year, we're going to have, you know, continued innovation and competition within those spaces, which if you look at what's happened in the oncology space, it's just going to provide more access to, you know, a lot of these patients and help bring down healthcare costs.

[00:14:27] Neil: Well, really great thoughts and, and an interesting conversation again, Kathy. I appreciate your time and hope you have a good day. 

[00:14:32] Kathy: Thank you. You as well.