Andrew Bourgoin has spent over 15 years working across the U.S. pharmaceutical and biosimilars markets, leading initiatives in strategy, analytics, and market intelligence. As founder of Bourgoin Insights Group and creator of All Things Biosimilar, he is dedicated to building practical solutions that help organizations drive meaningful results.
Human Transcribed
Andrew Bourgoin:
Biosimilars are such a fascinating part of this overall healthcare industry that we have. I think that the overall savings that they provide, it's really important. And when you think about biosimilar savings in 2025 alone, biosimilars saved $25 billion for this system. And since the biosimilar market opened in the US, that number's 81 billion. These are not small numbers.
Chai Nussbaumer:
In 2026, the US FDA approved its 100th biosimilar, marking a major milestone in expanding access to more affordable medicines.
Micah Schweizer:
The US spends more per person on healthcare than any other country, yet many people still struggle to access the care and medicines they need.
Chai Nussbaumer:
In this episode, we'll examine how biosimilars fit into that picture.
Micah Schweizer:
We'll explain what they are, how they work, and explore the field's current acceleration.
Chai Nussbaumer:
I'm Chai Nussbaumer.
Micah Schweizer:
And I'm Micah Schweizer. This is Balancing the Future from METTLER TOLEDO.
Chai Nussbaumer:
On this show, we explore the world of science and technology and the solutions transforming our lives.
Andrew Bourgoin:
My name's Andrew Bourgoin, and I am the founder of Bourgoin Insights Group.
Chai Nussbaumer:
Can you start by telling us what biosimilars are?
Andrew Bourgoin:
So I think the easiest way to think about biosimilars is to frame it around something that we're all familiar with, which are generic drugs. Where biosimilars and generic drugs are the same is that they come to market after an innovative or novel medicine loses a period of exclusivity. And when they come to market, there's increased competition due to price, and then generics create increased access and cost savings to patients and the entire system. That's where biosimilars are just like generics. Where they're different is generic drugs and the novel products that generics are versions of are chemically synthesized. Biosimilars are biologic drugs. So these are actually protein products or monoclonal antibody products. So they're more complex, they're more challenging to develop and make. And for those reasons, among others, they're also some of the most expensive products in the marketplace. So biosimilars now create alternatives that are expanding access just like generic drugs for some of these very expensive products in the marketplace.
Micah Schweizer:
What are the patient benefits that come from the availability of biosimilars?
Andrew Bourgoin:
Number one, increased access, right? That is the goal here. And the increased access is a function of the number of versions of that product in the market. The second is increased cost savings. Now, sometimes that's tricky in the US healthcare system because there are so many different stakeholders in it. However, with more competition comes increased price compression, which then leads to savings throughout the system.
Chai Nussbaumer:
What are the criteria for developing a biosimilar? Are there certain therapies that get picked up more often than others?
Andrew Bourgoin:
Yeah. So different companies would go through what's called a pipeline selection process. We have X amount of dollars to invest, which novel products that exist are we going to target and then develop to bring to market? That selection process includes various criteria, which likely has some variance from company to company. But for the most part, you often see manufacturers of biosimilars targeting, number one, products or therapies that have longevity. These are standards of care. These are medicines that will be around for a while. Number two, these are medicines likely driving significant revenue so that when they bring a version to market, they're going to recoup some of that initial investment that they've made.
The third component that I've seen is also alignment with some of the work or some of the products that they already have in the market. You may have a biosimilar manufacturer that's a company that also has, let's say, multiple retina products. They may then target additional retina products to bring to market because then of course they have a presence in that market. They have some commercial capability, a brand that's already familiar within a customer set. Now throwing an additional product in their market basket makes a little bit more sense and that helps focus some of that pipeline selection.
Chai Nussbaumer:
And so how are biosimilars actually made? Do they follow some sort of manufacturing path similar to the patented originator drug?
Andrew Bourgoin:
Yes, for sure. There's various different ways each product is developed and every product in some respect is unique, but to be able to develop and manufacture a biosimilar, you need to understand how the novel product is developed and manufactured. Now, there's two key things to understand there. The first is there's so many different elements of the process to develop the product that is different than just say a chemically synthesized product, which is you need to make the molecule. There's a process to develop some of the monoclonal antibodies or the fusion protein products that are the biologics that have biosimilar versions of them. That can take years. And more important to understand is that there's IP protection around some elements of that process that certain biosimilar companies need to be aware of in order to be able to effectively bring that product to market.
Micah Schweizer:
So how accessible is the original product development process and how much is reverse engineering trying to get at this molecule?
Andrew Bourgoin:
Yeah, it's probably a mix of both. There's a range of companies that participate in the development and manufacturing of biosimilar products. You have well established global pharma brand companies. You also have, I would say, traditional major generic companies. And on either sides of that equation, you're going to have varied capabilities from an R&D perspective. On one side of the equation, brand companies that make novel therapeutics and have highly sophisticated R&D centers, they may be able to figure out the recipe of a product a lot easier than some of the emerging companies that their background is more traditionally on the chemically synthesized products. So that reverse engineering, as you said, may come a little bit easier for folks who already know how to make biologic drugs than others. Another important part is getting those insights from your legal team, your IP team that's also evaluating from a patent perspective, how are these products covered?
The alchemy of those two teams working together is kind of where the magic happens. And some companies are able to design their biosimilar in a way that respects the patent estate that exists while also aligning to all of the scientific regulatory requirements to gain approval.
Chai Nussbaumer:
Are there any manufacturing innovations that really drive efficiency gains in the biosimilars field?
Andrew Bourgoin:
Yeah, so another great question, and I think when you come back to some of those underpinning tenets of biosimilars, price competition, that is a function oftentimes of your ability to manufacture efficiently. And manufacturing biosimilars, it's complex, it's expensive. So are there ways that we're seeing companies increase the efficiency of their manufacturing processes and also increasing efficiency across their supply chains in order to basically reduce their cost of goods so that they have a little bit more room from a price perspective to remain relevant for longer? The answer to that question is yes.
Chai Nussbaumer:
Hey, Micah.
Micah Schweizer:
Hey, Chai.
Chai Nussbaumer:
Did you know, Micah, that biosimilars go through clinical trials too, just like other drugs?
Micah Schweizer:
I can imagine, but is the process different somehow?
Chai Nussbaumer:
It is different. Historically, trials focused on how highly similar biosimilars were to the originator drug. This meant going through large, expensive analytical trials. Now because lab testing earlier in the process is so thorough, the FDA and other global regulators are waiving this final stage.
Micah Schweizer:
Okay, so could this help regulators approve biosimilars faster and make them more affordable for patients?
Chai Nussbaumer:
Exactly. And then the next step involves getting these medicines to patients.
Andrew Bourgoin:
This is where there's nuances in the US healthcare system that are both important to understand and honestly from my perspective, frustrating to respect and recognize when we talk about biosimilars right now almost as this overarching brand or single entity, but of course you could have biosimilars of very different products that in the US market are helping treat patients with very different illnesses and those products also may be dispensed in a hospital, they may be dispensed or self-administered by the patient themselves, and they also could be reimbursed through different parts of our healthcare system here in the United States. All those different nuances would impact potentially when the product actually could get to patient. And most patients out there have an insurance and your insurance has a pharmacy coverage or a formulary that identifies what products they will cover and the degree of which they'll help cover the payment for those products.
Unless a biosimilar is included on a formulary, it's going to be hard to get really enough coverage and support to pay for that product. There's nuances here. There's co-insurance, there's copay, there's patient assistance programs that can help with all of those things, but it's really challenging for a biosimilar to get the patient unless they're covered on formulary. There are new avenues, right? I think you're probably familiar with some of the direct to patient opportunities like Mark Cuban's Cost Plus Drugs and some other entities out there that are forming, but then you also have medical benefit or products that don't fall under the pharmacy side of reimbursement. And some of those products could be available as soon as the product launches because different mechanisms on that side of the equation.
Chai Nussbaumer:
And can you tell us some biosimilar success stories? Are there any populations that were able to access healthcare that they couldn't before?
Andrew Bourgoin:
Yeah, absolutely. I would almost measure biosimilar success in maybe two or three different vectors. The first is just overall cost savings to the system. And when you think about biosimilar savings in 2025 alone, biosimilars saved $25 billion for the system. And since the biosimilar market opened in the US, that number's $81 billion. These are not small numbers, right? Number one.
Chai Nussbaumer:
Wow.
Andrew Bourgoin:
Number two, obviously if we're measuring kind of savings, but also access, you might think, "Well, have there been any markets where the size of the market has grown, has expanded?" There's a few really interesting cases here. One that I'd highlight is the Soliris market. This is a market that was actually very small patient population. There are two biosimilars on the marketplace now. We've seen evidence that that marketplace is expanding. That's very exciting.
Chai Nussbaumer:
And you mentioned briefly earlier that the US FDA passed a major milestone for biosimilars, even so big that you had to work this week. Can you expand on what this milestone was and why it's so important?
Andrew Bourgoin:
There was a major milestone a few weeks ago, which was that the FDA approved the hundredth biosimilar in the US market. Of course, this is a big deal, right? Seeing more opportunities for biosimilars receiving that approval and then hopefully coming to market increases that opportunity for access and cost savings. This week we saw another milestone, which was a company filed for the first biosimilar application for a product called Keytruda. Now Keytruda is the top-selling drug in the world, at least as of last year. This is a product from Merck and this week a company filed or announced that the FDA had accepted for review their application for a biosimilar version of it.
So this begins, and this company will be one of probably a dozen, if not more, companies to file an application for a biosimilar version of Keytruda. And what does this mean? This means that in time we will have various versions of one of the most successful life-altering oncology products that we've seen in the past two decades now available in the marketplace.
Chai Nussbaumer:
And how does the global competition look for biosimilars?
Andrew Bourgoin:
Yeah. So there's two different ways I would think about competition globally for biosimilars. Maybe the first is trending just overall, how many companies are participating in the market? Is that growing or shrinking? And the second is thinking about the number and type of biosimilars that they're targeting. So let's talk about the first one. Overall, we're actually seeing more companies lean into biosimilar development and manufacturing. And one of the reasons, Chai, as you mentioned, is some of those development costs are coming down. That phase three trial reduction is certainly a part of that. If the cost and time to develop, manufacture, and eventually gain approval and launch a biosimilar is less, that attracts more companies to participate in the market. So that's great news.
The second element here is the types of brand products that they're targeting. There was recently a report recently, I guess it was two years ago now, that came out from a company called IQVIA, and they did an analysis to understand how many products between now, and I think the horizon was 2034, are being targeted by biosimilar companies. The number was not what they had hoped. It was about 90% of products in that cohort were not being targeted for biosimilar development. Since then, my company has done analysis to update that, to better understand the number of biologics that are being targeted for biosimilar development. That number today is down closer to 70%. So more companies are participating in this market and now they're even targeting more biosimilars for entry development into the marketplace. So globally, I think that we're seeing competition continue to increase, and of course this will read through to more products, more access, and more cost savings.
Micah Schweizer:
So if we look to the future, where is the biosimilars field headed in the near to medium term?
Andrew Bourgoin:
Let's think about this, number one, in the next products that we likely will see biosimilar versions of. That's one of the fun parts about working in biosimilars is you know the targets that are next, right? So in the US, a product called Xolair, this is a product that originally was for asthma. It since grew indications for urticaria as well as for food allergy. That market for biosimilars just opened up two weeks ago and we're anticipating additional biosimilars over the course of the next year to launch. And we're also expecting to see more biosimilar competition in the retina field for a product called Eylea. This is a product known for wet AMD and some other indications as well. But between now and 2028, 2029, there will be a lot of focus on some of the massive blockbuster oncology products.
I mentioned Keytruda, that's one. Another one is a product called Opdivo. These are PD-1 products that, again, changed the overall kind of oncology landscape over the past decade plus. Beyond that, where's it going? You're reaching a whole set of patients that would only have one choice, the brand, and also you're not competing with 12 other biosimilar manufacturers to gain market share. So I could see more competition for brand products that maybe in the past had not been targeted for biosimilar competition because more companies are getting into this space and they want to find kind of a niche area to compete.
Chai Nussbaumer:
And is there anything else that we didn't ask you that you'd like to add to the conversation?
Andrew Bourgoin:
How much time do we have left? Biosimilars are such a fascinating part of this overall healthcare industry that we have. And just like generic drugs, I think that the overall savings that they provide, the choice that they grant physicians, pharmacists, different stakeholders in the value chain, and of course patients, it's really important, right? So much focus is put on innovation as it should be. At the same time, the competition that biosimilars bring really spurs that innovation.
Micah Schweizer:
Thank you so much. It was a really interesting conversation. Appreciate your time.
Andrew Bourgoin:
Absolutely. Thank you both so much. Have a great day.
Chai Nussbaumer:
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Micah Schweizer:
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Chai Nussbaumer:
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