Sean McGowan, senior director of biosimilars at AmerisouceBergen, discussed the current biosimilar pipeline and the potential impact on the market those products may have.
To watch part 1 of this interview, click here.
To watch part 2 of this interview, click here.
The Center for Biosimilars® (CfB): Hello, I’m Matthew Gavidia. Today on MJH Life Sciences™ Medical World News, CfB is pleased to welcome Sean McGowan, senior director of biosimilars at AmerisourceBergen. We don't have any interchangeable biosimilars in the United States yet, but there is a push toward making interchangeability automatic for insulins. Can you give us the industry insider's view of this issue and what you see happening down the pike?
McGowan: So, interchangeability is an interesting concept that’s been discussed a lot since the BPCIA [Biologics Price Competition and Innovation Act] was enacted 10 years ago and as products have come to market. If we look at what’s happening in other markets around the world, specifically in Europe, the concept of interchangeability doesn’t exist there. But in the United States, it does exist and you’re right that there aren’t any products that currently have that designation.
But I will say that there are 2 companies that have engaged in interchangeability studies for products that are going to be launched in the next couple of years. Boehringer Ingelheim, I believe, has completed their interchangeability study for their Humira [adalimumab] biosimilar that is set to launch in 2023. And also, through the ClinicalTrials.gov website, I saw that Pfizer put in an application for an interchangeability study at the beginning of this year. So, we do have 2 manufacturers that have engaged in the process. We don’t know what the outcomes of trying to earn that designation looks like, but I think as an industry, we’re very excited to see what the FDA determines and then what that will mean for products in the future.
As far as insulins are concerned, I think this is something that could help to push interchangeability in the United States. [Recently,] a congressional representative from Wisconsin [Representative Glenn Grothman, R-Wisconsin] proposed a bill that would create automatic interchangeability for any insulin biosimilars that are launched in the United States. So, one, that’s really encouraging specifically since we’ve had a number of insulin products that have now switched over to the biosimilar category, under the FDA’s determination, and that transition happened back at the end of March 2020.
So, we have a couple of new biosimilar product categories that now exist, and in looking at that insulin market specifically, you’ve got 3, quote, unquote, innovator products there and 6 insulin biosimilars that are currently being developed. A couple are in phase 3, so I don’t think we’ll see a launch of a true insulin biosimilar in calendar year 2020. But I think it’s definitely a possibility in calendar year 2021. If this bill is able to successfully get passed, I think it creates, again, affordability, access, and choice. Especially in the insulin market, you can’t talk about drug pricing without insulins being mentioned.
I think patients and physicians are going to be impacted in a very good way if a type of interchangeability is allowed for insulin products. And I also think it helps to move the conversation along around interchangeability for these other, quote, unquote, legacy biosimilar products that have existed for several years that don’t have that designation.
It’s interesting to follow the switching studies that are going on around the world and seeing that there is safety and efficacy in being able to switch patients off of an innovative product, onto a biosimilar product, and onto another biosimilar. There are several studies that have proven that it is safe and effective to do so, and hoping that the United States regulatory bodies look at that data and take the outcomes in a global context and learn from other markets that are more mature and further along in the launching and utilization of those products as we start to bring them into the United States.
CfB: There are not any biosimilars currently on the market covered by Part D or a pharmacy benefit. Do you anticipate that these biosimilars will be entering the market in the near future?
McGowan: Yeah, absolutely. Currently, all 18 products that have launched on the market—broadly in the supportive care, oncology, and the anti-TNF [tumor necrosis factor] markets—are all covered under that medical benefit, or Medicare Part B. I will say that we do see a tiny percentage of some of the supportive care products that do sometimes get covered under Part D, but by far the majority is covered under the medical benefit. So, yes, we absolutely anticipate seeing products launch into that pharmacy benefit, or that Part D space, in the future.
Going back to the insulins market conversation, we anticipate those products to be covered in that pharmacy benefit as early as 2021. But more broadly, as we look at how the biosimilar market is going to evolve and unfold in the next several years, the year 2023 is the one that sticks out to me the most. That’s because we will see 6 Humira biosimilars launch in that calendar year time frame. So, each of those manufacturers have their launch date already set. And currently, that product’s covered under the pharmacy benefit. Since it’s a self-administered product, I would anticipate a pretty rapid uptake and adoption of those products in 2023 and beyond.
CfB: Can you tell us about your latest report with Michelle Jesse at AmerisourceBergen? Can you give us a key point synopsis?
McGowan: Yeah, sure. So, the report that we’ve made publicly available is a US biosimilar market and pipeline report. And so, what we’ve done is essentially taken all of the existing markets with products that have been approved and launched and organized them in a fashion that’s easy to read and understand and gives everybody the most accurate information on what products are on the market, when they launched, what categories they were launched in, what the innovator products are, and who the manufacturers are.
And then, the second part of the report outlines all of those markets and the insulin market, the human growth hormone market, the infertility market, and a couple of other markets, where biosimilar products are currently in development and going through clinical trials. So, it’s basically a forward-looking view of what products are being studied in clinical trials and could potentially be approved and launched into the market in the coming years.
What we’ve done is organized it in that fashion as a reference and as a point of education for our manufacturing partners, our customer partners, our advocacy partners, and anybody that is operating in health care and wants to get educated on biosimilars. They can access this for free. If you Google “AmerisourceBergen biosimilars,” it'll bring you right to our biosimilars page and right at the top of that page, it provides a link to register for the report.
And the nice thing about the report is that it’s going to be up to date with the most current information that we see and hear in the news. [We get out information from] earnings calls from manufacturers, manufacturers’ websites, and other news sources. And we basically push it out to our partners who have registered to receive the report as market events happen. So, if a product gets approved by the FDA, we’ll update the report. Once a product launches under the market, we’ll update the report. If there are significant developments in clinical trials, products, or new markets where products start to get developed, we’ll update that report. So, we most certainly encourage everybody, if they haven't gone there, to Google “AmerisourceBergen biosimilars” and register for that report.
CfB: And in their report, as you just alluded to, you discussed the biosimilar pipeline for many drugs for which biosimilars are not available. Lastly, can you tell us about some of the most exciting ones?
McGowan: Yeah, absolutely. I’ll start with products that haven’t launched yet and then I’ll go into markets that don’t have any biosimilars. So, as we look at the existing markets from an abroad perspective—supportive care, oncology, and anti-TNF—if you look at the number of products that are currently in development, it is super encouraging. That indicates to me that companies are investing in their biosimilar platforms and manufacturing capabilities and development capabilities to launch products into these existing markets. And you'll see in our report that dozens of products are in phase 1, phase 3, or pending approval from the FDA that will be entering into the filgrastim [Neupogen], pegfilgrastim [Neulasta], Avastin [bevacizumab], Herceptin [trastuzumab], Rituxan [rituximab], and infliximab [Remicade] spaces. I think we’re going to experience in the next year or 2 this next wave of new manufacturers that are entering the biosimilar space.
So, if you currently look at the manufacturers that have products launched today, a lot of them are legacy, specialty, and reference companies like Amgen, Pfizer, Mylan, Teva Pharmaceuticals, Coherus Biosciences, and Merck. I think you’ve got a legacy there of manufacturers that are very familiar with how to develop, launch, and manufacture biologic products. With this next wave, we’re going to see a lot of companies that have legacy generic portfolios launching in this space. So, it’s going to be very interesting to see how they enter a new market, or a new space, that they may not have the same legacy that the current manufacturers have. So, it’s going to be a very interesting evolution of this market as these new manufacturers bring products into these existing spaces.
As we look at the biosimilar markets that haven’t had any biosimilars launch in them, the first one that I’m very excited about, and I think we should see a product launch onto the market as early as next year, is in the ophthalmology space. So, Lucentis [ranibizumab] and Eylea [aflibercept] are 2 biologic products that make, in the United States, several billion dollars in sales on an annual basis and have great penetration into the ophthalmology space. We have several manufacturers that are developing biosimilars that are referencing those 2 products specifically. And so, I think we could see the first Lucentis biosimilar launch, potentially, before the end of calendar year 2021. That’s a really exciting market update that could happen specifically for ophthalmology and ophthalmologists.
And then as we look at those product categories that were switched over to be considered biosimilars. So, for human growth hormone, insulin, and infertility products, like I said before, the FDA made a transition of those products into the biologics category. And so, you’ve got several [biosimilar] products that are currently under development. We probably will see an insulin biosimilar product hopefully before the end of calendar year 2021. For the human growth hormone, we could see a [biosimilar] product or 2 launch [in that space] as well. That’s exciting as well because now, you get this expansion of biosimilar products in markets that currently haven’t existed, but also, especially around the insulin market, as far as a cost in a WAC [wholesale acquisition cost] dollar perspective, much cheaper than the existing markets. In the oncology supportive care and infliximab markets, you’ve got products that are over $1000 or $2000 on a WAC basis, where the insulin market is going to be much cheaper. Hundreds of dollars as opposed to thousands of dollars.
So, I think that’s the other exciting thing that we’re tracking really closely. And then, as I mentioned before, in 2023, as those Humira products start to get introduced and utilized in the United States, that’s a very big market. Humira is the largest grossing pharmaceutical product not only in the United States, but in the world. And so, to have 6 biosimilars launch against that is going to be a pretty significant event, not only for the biosimilar market, but for the industry itself.
CfB: To learn more, visit our website at centerforbiosimilars.com. I'm Matthew Gavidia. Thanks for joining us.