Part 1: Sean McGowan on the Challenges of Bringing a Biosimilar to Market

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life SciencesTM Medical World News, CfB is pleased to welcome Sean McGowan, senior director of Biosimilars at AmerisourceBergen. Can you just introduce yourself and tell us a little bit about your work?

McGowan: Thanks for having me. I'm the senior director of Biosimilars at AmerisourceBergen. And so, I spend most of my time working with our manufacturer partners who develop and bring to market biosimilar products. I work very closely with those manufacturers in the prelaunch phase and then, as they are commercializing those products, bringing those products to market and helping those manufacturers manage the lifecycle of those products, ensuring access to those products, and ensuring access for our downstream and our shared customers. And then, I also work internally on the strategy of the biosimilar product category as a whole. So, figuring out how do we grow the category? How do we work with our hospital health system and our clinic customers to ensure that they have full open access to these products? And then, I work on general education about biosimilars and ensuring that any end users are fully educated on this merging product category and ensuring that the world is educated about these products.

CfB: Can you describe AmerisourceBergen and your role as a market facilitator for biosimilar developers and manufacturers?

McGowan: AmerisourceBergen is one of the largest wholesale distributors of pharmaceutical products in the United States and so, we work with pretty much every manufacturer that has products launched in the United States. Whether it be specialty products, reference products, generic products, OTC [over-the-counter drugs], we contract with them and ensure that we have access to them.

And then, we work with our downstream customers, who are more generally retail pharmacy customers, specialty pharmacy, oncology clinics, and other specialty clinic customers. So, basically, we're working in all different classes of trade. Basically, any site of care where a product is being dispensed, we are working with. So, we really are the glue that binds the market and brings the manufacturers from one side of the market and ensures access to those products for our customers that are on the other side of the market.

CfB: How closely do you work with the end users, their physicians and patients and across what breadth of the country?

McGowan: That's a great question. So, speaking about biosimilars specifically, we look at the [drug] category and the end users or our customers and cut them into 2 very broad buckets. One being in the specialty clinic space. So, you think about an oncology practice, or a rheumatology practice, or a GI [gastroenterology] practice. Any of those specialty practices and clinics that are independently owned that might not be part of a larger system but are kind of owned and operated by those physicians.

And then, our other kind of broad bucket is our hospital health system customers. So, that can be your largest networks that operate in multiple states all the way down to your more your midsize or your smaller, regional health systems that are serving those communities. And so, for biosimilars specifically, those are the 2 biggest “end users,” or customers as we consider them, to be utilizers of biosimilars. [We have customers] in every state in the United States. So, we're serving probably over 95% of hospital and health system customers.

CfB: And before we talk about some of the issues faced with biosimilars, let's talk about some of your predictions from last year. You predicted that 8 biosimilars would launch in 2020. Are we on track? Why or why not?

McGowan: Yeah, it's funny to think back to the article that you're referencing herein, and I think we published that just about a year ago, so, mid-September [2019] as we were looking towards calendar year 2020 and what the biosimilar market would look like? Obviously, the world looks like a much different place than it did a year ago. 2020, at the beginning of the year, was a really fast start for the biosimilar category. We've seen to date 6 biosimilars launch in calendar year 2020. We had a pretty big number of them that launched in that January, February, and into early-March timeframe.

But since then, we've only really seen 1 product launch mid-year. And it's hard to say what the rest of the year will bring given the global pandemic; we know that there have been slowdowns at every level and it'll be interesting to see what happens between now and the end of the year as far as products being approved and launched. Hard to say if we will get to 8, but 6 is the number that we're at right now. And like I said, the year started off at a very fast pace for biosimilars.

CfB: And additionally, you stated that during the 5 years from 2019 to 2024, biosimilars would achieve $70 billion in savings and almost double that by 2026. Are we on track and also, why or why not?

McGowan: You were referring back to the RAND Corporation study where I was doing a forward-looking calculation on the type of savings that biosimilar products were going to drive several years into the future. We don't have an exact number on what's been saved across the last year, but I believe that savings are happening. We know that they're happening. We're seeing an increase in the utilization of these products at every customer level. So, I believe that…, when we look back in this period of time, we'll be able to point to a significant amount of savings through utilizing these products.

And so, it's actually an interesting question and as we look at the world from fall of 2019 to fall 2020, what we're seeing and hearing from our collective group of customers, whether it's in the clinic space or the hospital health system space, is that there are financial pressures that are being imposed upon some of these larger customers, especially in the hospital health system space. These entities and these organizations are looking for ways to drive savings, and what's crept up to the top of the list to help drive the savings is utilizing biosimilar products, just because of the cost of the innovator products, and how heavily utilized those innovative products are. For a large health system, it can be in the hundreds of millions of dollars if you're talking about oncology care or dispensing an infliximab—that type of product—depending on the types of patients that are coming in being treated.

So, as customers, especially in the hospital health system space, look at their current utilization and then look at the amount of savings that biosimilars can drive, they're also looking at that overall spend in the pharmacy and saying that there's some real potential here and that there's something that we can do immediately to drive those savings. So, we're really encouraged by that.

We're hearing from our hospital and health system customers on a much more regular basis. Right now [we hear them] saying, "Hey, we need help deploying a biosimilar strategy. How do we switch over? How have others done it that have done it before us? And how have they done it successfully? Help us figure this out." And that's part of what we've always done at AmerisourceBergen is educate the market, deliver those insights, and help customers succeed in a situation like this.

CfB: Now, transitioning to the biosimilars market, what is happening when biosimilar developers launch a product and although it is theoretically cheaper than the reference product, it's not getting picked up by physicians?

McGowan: It's an interesting point and I think that this is a situation that continues to evolve based on the overall health system as a whole and whether products get adopted. There are a lot of factors that are involved. I think from the onset, even before a biosimilar is approved, or once it does get approval but before it launches, there's a significant amount of litigation and a legal battle that ensues between the innovator company and the biosimilar company. We've seen with every single biosimilar that's been brought to market that there's been some sort of legal action or litigation brought against the biosimilar manufacturer. So, even before a product is launched onto the market and becomes available for patients and physicians to utilize, it already has to overcome legal challenges and hurdles posed by those innovator companies.

But as you look at those products and as they come onto the market, there are challenges at every level, specifically in the health plan or the payer market, where health plans may or may not have a fully baked biosimilar strategy from a coverage perspective. So, you could have a physician, or a hospital, or health system out there that is looking to switch over to a specific biosimilar. But the payers that they are partnered with, are working with, and that are covering the patients that are walking through their doors, that product may not be specifically covered by that payer. So, that creates a challenge. I think the issue with rebates is another one. It's another hurdle. It's another defense mechanism that innovator companies can utilize to block the coverage of biosimilars. We've seen that play out in the infliximab market, where biosimilars have been in the space for over 3 years and the penetration of those biosimilars into that innovator product market share has not really been significant.

So, I would say it depends really on the type of the product that you're talking about, the type of market, who are the innovator companies, the commercial strategies that are put in place to defend that [innovator] market share, the litigation strategies the [innovator companies are] putting into place.

I also think that another major hurdle which continues to prevent the quicker uptake of biosimilars is really around education. How educated are the payers and health plans around biosimilars? How educated are the physicians, the directors of procurement, and the pharmacists that are ordering and starting to utilize these products, and what we see is that every customer is at a different stage of education around biosimilars. Some are at the very beginning stages, where they're just kind of getting their heads wrapped around what products are available and what innovator products are being referenced.

And then all the way to the other end of the spectrum, customers that are much more advanced that have adopted products already understand fully that they don't need to go out and educate their pharmacists and their physicians. They know what products are available, they know how to order them, they know how to navigate the potential payer coverage challenges there, and they know how to get the prior authorization. They know where to go and they've done this before. So, it's kind of a combination of things once a product is launched and whether or not it will be adopted.