The Changing Biosimilar Landscape: 2020 and Beyond

In Partnership With: AmerisourceBergen

2020 has been an interesting year for many reasons, but for AmerisourceBergen it will be known as the year competition increased in the oncology biosimilar Trastuzumab market. The company launched six biosimilar products in 2020 with most launching in the January-March time frame.

Of course, COVID-19 changed the way physician practices and health systems interacted with patients, but Sean McGowan, senior director of biosimilars at AmerisourceBergen, said customers have found their footing in this new operating environment. The pandemic has presented opportunities for greater engagement with customers who are building a strategy around adoption and cost savings.

It has been a successful year, said McGowan, and 2021 looks just as promising. He anticipates new manufacturers and a second wave of products into existing biosimilar markets.

“Companies continue to invest in their biosimilar platform,” he said.

Hear more from AmerisourceBergen’s Sean McGowan, in his interview with Fierce Pharma. After watching, if you’re looking for more information, visit

Rebecca Willumson: Hello everyone. I'm Rebecca Willumson. I'm the publisher of Fierce Pharma. And I'm here today with Sean McGowan, Senior Director of Biosimilars at AmerisourceBergen. Sean, thanks so much for joining me today.

Sean McGowan: Thanks for having me.

Rebecca Willumson: So Sean, before we get into our interview, can you tell me a little bit about yourself and what you do?

Sean McGowan: Yeah, sure. So I'm the senior director of biosimilars at AmerisourceBergen. I spend a majority of my time working with our manufacture partners who are developing and commercializing biosimilar products in the U.S. So spend most of my time with them working on their pre-launch strategies, how they're going to come to market with these products, what channels they're going to distribute these products into, what customers they're focused on. So all things kind of pre-launch and post-launch related. I also lead the strategy for the biosimilar product category at AmerisourceBergen, and that means that I work very closely with our account teams that are calling into our customers who are purchasing these products. So namely, the oncology and specialty practices that are utilizing biosimilar products, as well as the hospital and health system customers and organizations that are utilizing these products. And really helping these customers think through their biosimilar adoption strategy. So informing them on all of the market happenings, what products are available, what products are coming, and how they can formulate their strategy to integrate biosimilars into their care plans.

Rebecca Willumson: Great. So let's move into our interview section. I want to talk about 2020. Looking back, what do you see as some of the high points for the biosimilars market?

Sean McGowan: Yeah, so 2020 has been an interesting year for a number of reasons and especially in healthcare and the pharmaceutical industry. So we started the year off to a very fast start. Today, we've had six products launch in the biosimilar category. We had a majority of those products launch in that January to March timeframe.

Sean McGowan: We also saw the most competitive biosimilar market emerge in the trastuzumab space. And we currently have five biosimilars that have been developed and launched in reference to the innovator product Herceptin. So the result of the increased competition, not only in the trastuzumab market, but in all the biosimilar markets has increased the potential for cost savings. We're seeing innovator net prices decline just with the mere presence of a biosimilar competing directly against it. Also, the FDA transition dozens of products over into the biosimilar product category at the end of March of this year. So now the U.S. has paved the way to increase competition with some of these new product categories, drive cost savings by opening up some of these new markets and especially in the insulin market. So now we have biosimilars that are being developed in reference to several short- and long-acting insulin products. And so there's great potential here for these emerging markets, as well as the increased cost savings that could come along with newly launched products.

Rebecca Willumson: So would you say 2020 was a successful year?

Sean McGowan: Yes, absolutely.

Rebecca Willumson: So I want to talk about COVID. In your opinion, did the pandemic hamper or bolster the biosimilar market?

Sean McGowan: So COVID definitely had an impact on our physician practice and health system customers. As the pandemic kind of was emerging in the U.S., all of these customers were figuring out their pandemic response, but now we've seen that these practices and these health systems have a better handle on how to operate in the current environment. From a biosimilar perspective, COVID has definitely created an opportunity for biosimilars to continue to deliver access, affordability, and savings. All of our customers are facing intense financial and economic pressures due to the pandemic, having to shut down, having to adjust and change how they treat patients, integrating telemedicine into many of these practices and these operations, how a customer or how patients enter clinics or hospitals, and how they're cared for has added additional layers of work and inevitably expense.

Sean McGowan: But we see, and our customers definitely see, that biosimilars can help deliver savings as they adjust their strategies in this new world. We're definitely seeing an increased amount of engagement, especially from our health system customers and that side of the business. They're engaging us at a rate that we've never seen before. I would say if we were having this conversation a year ago, maybe I'd be having a conversation with a health system customer maybe once or twice a month. Now they're contacting us very much on a weekly basis, all different customers from all around the country, to talk about their biosimilar strategy, how we can help them adopt biosimilars at a higher rate to help drive cost savings.

Rebecca Willumson: I want to shift gears to 2021. What are you expecting to launch? And then as a follow-up question, do you think there'll be any notable market entrance that you'll be watching closely?

Sean McGowan: No, a great question. And really looking forward to 2021 for a number of reasons. So as I mentioned before, today we've had six biosimilar launches in 2020. And as we look to the future, we anticipate new product markets to open up. To date, the FDA has approved 28 biosimilar products. Eighteen of those products have launched and are in the market in the U.S. And these 18 products are competing in seven product categories including the supportive care space, the oncology space, and the anti-TNF space. In 2021 and beyond, we'll definitely see some additional product launches into these existing markets. That's going to increase the competition, access, and affordability, and cost savings for these existing products. So we're kind of seeing what I'll call kind of the second wave of products entering into these existing markets. We're going to see a lot of new manufacturers launching biosimilar products, which is really exciting. And I think indicates the health of the market where companies continue to invest in their biosimilar platform.

Sean McGowan: We're hopeful that we'll see the first insulin biosimilar get approved and launched in calendar year 2021. We're anticipating at least one product, could be more depending on how the clinical trials go. And also, there's the potential for the first ophthalmology biosimilar to get approved and launched in calendar year 2021. So the Lucentis innovator product has several biosimilars that are being developed in reference to it. And some of the leading candidates, from a clinical trial perspective, are heading towards the end of their clinical trials and looking for review from the FDA. So we could potentially see that ophthalmology market open up towards the end of calendar year 2021.

Rebecca Willumson: So from a policy perspective, what do you think needs to happen at a federal level to continue to support biosimilar adoption and innovation in the U.S.?

Sean McGowan: That's an interesting question and a very timely question, considering we're coming out of the 2020 election cycle here in the U.S. So the current environment definitely presents the potential for some groundbreaking government policies to help support and grow the biosimilar market. A month or two ago, we saw a new house bill get proposed. H.R.8190 from a representative from the state of Wisconsin is proposing to make insulin biosimilars automatically interchangeable upon approval. This would definitely be a groundbreaking piece of legislation and would definitely help the overall product category. Currently, we don't have any interchangeable products in the United States. So this could be the first of its kind and I think shine some light on the issue around interchangeability, which is really exciting. And we also hope that legislators push for policies that encourage the adoption of biosimilars.

Sean McGowan: The stalled Prescription Drug Pricing Reduction Act includes a policy change that would increase reimbursement for biosimilar products from its current rate to a rate of ASP plus eight, which is definitely creates a little bit more of an incentive to utilize these products, which is the intent of that piece of legislation. We're also going to closely monitor what's going on at the Supreme Court as they begin to hear opening arguments as it relates to the Affordable Care Act. I think from a perspective of our government affairs and policy experts at AmerisourceBergen, they all agree that Congress agrees biosimilars will play a key role in reducing drug costs and overall healthcare costs in the U.S., and I think it's one of the few issues within the healthcare policy space that is garnering balanced, bipartisan support. So we're expecting some really good movement in the legislative year 2021 around biosimilars and how policies can help increase the adoption and utilization of these products.

Rebecca Willumson: Yeah, I think we can all agree on that. So that's all the questions that I have. Do you have any remaining thoughts or takeaways that you want to leave us with before we go?

Sean McGowan: Just a few. Again, as we started out the conversation here, 2020 has definitely been a very interesting year from a number of perspectives, especially in healthcare and especially within the pharmaceutical market. I think from a biosimilar perspective, it's been a very successful year. I'm very optimistic about what's to come in the future. As I mentioned, we've got a couple of new markets where biosimilars are being developed and that could open up in the next calendar year. And as we kind of march towards 2023 with the multiple entrance in the Humira space, we'll start to see these markets really open up and deliver on that open access promise and that promise of cost savings. So I think we're in a great spot, and I'm very excited to see what the category is going to deliver in the near future.

Rebecca Willumson: Well that's great. Well, thank you again for joining me today, Sean. I really appreciated the conversation.

Sean McGowan: Absolutely. Thanks for having me.