This article is sponsored by Sandoz, a Novartis division, and global leader in generic pharmaceuticals and biosimilars.

When I started working in the health care industry over 25 years ago, I was compelled by a passion to make a difference and improve the lives of those around me. Ultimately, that mission brought me to Sandoz, where I’ve had the privilege to develop and drive strategies to get critical medicines into the hands of those who need them – at a more affordable price. Through this work, I’ve seen firsthand how certain medicines can be cost-prohibitive, particularly for people living with a chronic illness who may have previously had to either forgo treatment or settle for less-effective therapies. This is especially relevant in the U.S., given rising health care costs and challenges in accessing care.

Fortunately, there is momentum across the health care ecosystem to address these challenges and transform the future of care for patients. In the treatment landscape, one viable solution is biosimilars.

Biosimilars, or biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product, can help address the growing health care challenges we face in the U.S.

Many patients who need biologic medicines have chronic conditions that require lifelong treatment to help manage their symptoms. This often causes great financial burden, forcing some patients to skip or delay doses and necessary care. With biosimilars, patients and their care teams don’t have to choose between efficacy and safety or savings, meaning greater access to critical care.

The financial impact of biosimilars on the broader health care system is also significant. Since 2015, biosimilar medicines have saved U.S. patients and health systems more than $13 billion. These savings can deliver lower out-of-pocket costs for patients, drive competition that helps make more room for new and innovative medicines and increase sustainability for an overburdened U.S. health care system.

Unlocking the potential of biosimilars in the U.S.

When I joined Sandoz in 2010, the U.S. Congress had only just enacted the Biologics Price Competition and Innovation Act (BPCIA), which provided a regulatory pathway to biosimilars in the U.S. The BPCIA opened the door for manufacturers like Sandoz to bring more-affordable biologic medicines to U.S. patients, and five years later, we did just that. In 2015, Sandoz launched the first FDA-approved biosimilar, transforming the biologics market landscape and the way we think about patient access and care.

Nearly eight years later, 40 biosimilars are now approved and 25 have been launched in the U.S., resulting in 150 million more days of additional patient therapy than would have been possible otherwise. While this is comparatively low compared to the 86 biosimilars approved in Europe since 2006, it’s clear that the U.S. is making strides to provide patients with more-affordable treatment alternatives.

Oncology biosimilars are a prime example of the potential of these medicines. The use of new biosimilars has saved U.S. patients with cancer more than $3.5 billion since their introduction in 2015. They’ve also cut the growth rate in oncology spending by nearly half, and this is projected to continue to decline over the next four years.

Another 120 reference biologics are set to lose exclusivity over the next decade, allowing new biosimilars to launch and expand patient access to biologics – especially in critical disease areas such as neurology and rheumatology, where biosimilars are not yet available. This will have a significant impact for U.S. patients who otherwise may not have had access to critical biologic treatments. In fact, some estimates predict that as a result of increasing biosimilar availability, an additional 1.2 million U.S. patients could gain access to the life-changing biologic medicines they need by 2025.

This is particularly exciting, not only because of the potential to lower the costs of biologic medicines and make care more accessible to patients, but also because biosimilars can help make way for the next generation of medicines by spurring new innovations and scientific breakthroughs.

Fueling future innovation

Without competition, innovation wouldn’t be possible. Biosimilars propel innovation by creating competition in markets that have been unchallenged for more than a decade. As more biosimilars become available, many markets will experience unprecedented competition, driving companies to create more choices for patients and physicians. Savings driven by increased competition can also be reallocated to meet the challenges of caring for a growing aging population.

This year will be a true test of this, as key biologic medicines are coming off-patent and several biosimilars are slated to launch in new markets. In the short term, patients in critical disease areas such as gastroenterology, rheumatology, dermatology, and neurology will have more treatment options while health care companies will explore further drug development and discovery to address rising competition.

Looking ahead

As the availability and use of biosimilars increase, there will be new challenges on the horizon that demand attention, including this year’s launch of new pharmacy benefit biosimilars and ongoing barriers to adoption, such as biosimilar misinformation. Additionally, incentives such as pharmacy benefit managers’ rebate preferences continue to present obstacles that hinder patients’ access to lower-cost medicines, which will take bipartisan support and collaboration among health care stakeholders to address.

Despite these hurdles, biosimilars continue to prove their value for patients and health systems alike. Just as the generics market has transformed care for patients, biosimilars can do the same if widely adopted. The sooner physicians, patients, and payers realize this potential, the sooner we can change the long-term trajectory of U.S. health care.

Timothy de Gavre is vice president and chief commercial officer, Sandoz US.

Note: This interview was recorded in December 2022.

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Transcript

Kevin Pho: Hi, and welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. My name is Kevin Pho, founder and editor of KevinMD. Today we have a special sponsored episode talking about biosimilar medications and why they matter to you. I’m joined by Tim de Gavre. He’s vice president and chief commercial officer at Sandoz, where he’s also a member of the Sandoz U.S. executive committee. Tim graduated with honors from the Wharton School with an MBA in health care management and cum laude from Princeton University. Find out more at sandoz.com. That’s s-a-n-d-o-z.com. Tim, welcome to the show.

Timothy de Gavre: Kevin, it’s great to be here. Thank you for having me.

Kevin Pho: So we’ll get to the meat of our interview in a little bit, but first off, just briefly share your story and journey to where you are today.

Timothy de Gavre: So, Kevin, I’ve been working in health care for almost 25 years. I started out in a small health care consultancy, then venture capital, and then got my MBA, and I was working at McKinsey in New Jersey. I was having a great time; I was actually living in New York. And I got this interview at this Sandoz place, and it was for biosimilars. I didn’t know what biosimilars were, and I thought it was a great opportunity to practice my interview skills, right? There was no way I was going to move to Munich, where the position was based, leaving New York. And I went, I did the interviews, I met the people, and three months later, I was on a flight across the Atlantic, changing my life completely.

A lot of it was because of the passion and the dedication that I saw on the team that was really leading this biosimilar effort for Sandoz. I think it was also that people who were leading this business had been directly impacted. It was more than just patients; it was family members who had been denied access to these critical medicines because of cost, and it really brought in the patient and made it personal. So when I joined Sandoz in 2010, this was something that was very personal. This was a mission that Sandoz was on, to really improve access to these critical medicines for patients, and those patients meant family members, meant people very personal to this group. And Sandoz has really been a leader in this field. We launched and got approved the first biosimilar in Europe in 2006 and in the U.S. in 2015.

Kevin Pho: All right, so let’s talk more about biosimilar medications and why they matter to you. Now, for those who might not be familiar, what exactly is a biosimilar medication, and how do biosimilars differ from generic medications?

Timothy de Gavre: Yeah, so biosimilars kind of have this funny name, right? Biosimilar. So why are they similar? Well, biosimilars are basically FDA-approved biologics that are similar to a reference medication. They’re similar because the medications we’re talking about are proteins, and proteins are very complicated. They have inherent variability, but they go through a rigorous regulatory process, and at the end, the regulatory authorities confirm that biosimilars have the same safety and efficacy as the reference product, and they go through clinical trials. They’ll always have a little bit of this funny name of biosimilar, because they can’t be identical. If you think about generics, they come from chemistry. You can be certain that the molecular structure is identical for a small molecule, where you can’t with a protein therapeutic. But what I always take solace in, and what really resonates with me, is that for the patient, there’s no impact. You have the same safety and efficacy, and you can really feel confident in that because of the really stringent regulatory process this goes through with the FDA.

Kevin Pho: And what are examples of diseases or conditions that could be treated with biosimilar medications?

Timothy de Gavre: Well, where we are seeing a lot of impact in the U.S., especially, is in oncology. In oncology, there have been a lot of products that have lost exclusivity where biosimilars have launched, products like trastuzumab, bevacizumab, and filgrastim, which are products from Sandoz. And we’ve actually seen real acceptance from oncologists for biosimilars. They’ve been enthusiastic about using these products, they’ve seen the impact it’s had in terms of savings, and they’ve also seen that the patients have responded very well to these therapies. Also, in the field of rheumatology, if you’re talking about rheumatoid arthritis or psoriasis or inflammatory bowel disease, Crohn’s disease, these are also areas where biosimilars can have a good impact.

Kevin Pho: So what are some specific cancers that biosimilars are used for?

Timothy de Gavre: Yeah, so biosimilars are similar to the reference products, right? And the reference products where biosimilars are coming to market are used in non-Hodgkin’s lymphoma, follicular lymphoma, breast cancers, liver cancers, just really across the gamut of oncology indications. They also can be used for supportive care, so for neutropenia, like the filgrastim that Sandoz promotes here in the U.S. So really, they can be terrific therapies for many significant and serious oncology indications.

Kevin Pho: And why should health care prescribers feel confident in prescribing biosimilars?

Timothy de Gavre: Well, I talked a little bit about the therapeutic benefits, right, and the rigorous regulatory pathway that biosimilars need to go through. So, first of all, you can feel confident that the regulators have really put this through a lot of scrutiny. These products have gone through clinical trials, and regulators aren’t going to let something out that they have any concerns about. I think also, for physicians, this is about making sure that there’s the space and the budget to pay for that next round of innovation. If you look at what’s happened with generics, prescribers have gotten very comfortable with prescribing generics, when maybe 30 years ago there were a lot of concerns around them. Now generics are accepted, and I think we’re going to the same place with biosimilars, which again have that significant regulatory scrutiny and can have a real impact on the next round of innovations for prescribers.

Kevin Pho: So let’s say I’m an oncologist and I have a gamut of medications to prescribe. What kind of questions should I ask myself if I want to consider a biosimilar medication?

Timothy de Gavre: I think there’s the first question, around cost and the patient. One of the things we’ve seen is that for patients, it can actually have a significant impact on out-of-pocket costs. It can reduce a patient’s cost by up to 45 percent, according to some studies. So there’s, first of all, can you actually have a real impact on the patient by reducing their costs? Then I think you look at the data, right, and make sure that you’re comfortable that the data that got the product approved shows the biosimilarity, and you feel comfortable that this product will have the same safety and efficacy as the originator product. And then I think you try it out with your patients and see how it works.

There’s no doubt that biosimilars have a huge impact on health care systems and the affordability of these medications. They make health care systems more sustainable. So if physicians want to work in sustainable health care systems, continue to get innovations, and have insurance companies pay for those innovations, this is a great way to do it.

Kevin Pho: When you talk about the benefits of biosimilars to patients, is there a story, a case, or an example that can really illustrate that point?

Timothy de Gavre: Yeah, so if you talk about Sandoz’s biosimilar filgrastim, which is Zarxio, there was a study that demonstrated that patients had a 45 percent reduction in out-of-pocket costs when a biosimilar filgrastim was used. And that’s real impact on patients and their ability to afford their health care. When you think about your oncology patients who are having all of those issues, not only with their disease but then with insurance companies and trying to afford the treatments, that can have a real impact on their ability to continue to sustain it.

The other point to make here is that as biosimilars come in, as the costs go down, the barriers to actually getting access to those products will go down: the step edits, the prior approvals, all of the tools that insurance companies use to manage costs. You will actually generally see those start to go away as biosimilars become cheaper, so patients can get access to these products faster.

Kevin Pho: And in general, when it comes to coverage, Medicare and private insurers, how broadly are biosimilars covered by insurance?

Timothy de Gavre: So it will depend on the reference product. Especially when you start, you’ll see that they mimic a lot of what happens with the reference product. As costs continue to go down, as insurance companies begin to really realize those savings, we hope to see more access for patients, because those step edits go away, and the other tools that insurance companies use to limit access will be eliminated. And that’s really our goal as we work with insurance companies, to get that access improved.

Kevin Pho: So it sounds like biosimilars have had a significant uptake in oncology. Are we seeing the same level of uptake across other areas? I think you mentioned rheumatology earlier.

Timothy de Gavre: Yeah, and I think oncology has been a shining star. In other therapeutic areas, it’s slower, and a lot of that is around education of the physicians, but it’s also working with insurance companies, because insurance companies have a lot of power to control how fast switches happen. What we do see is that there are elements of the U.S. health care system that make switching from a reference to a biosimilar challenging from an economic perspective for the insurance companies, for the PBMs.

Kevin Pho: Today we have a special sponsored episode about biosimilar medications and why they matter to you. I’m joined by Tim de Gavre. He is vice president and chief commercial officer at Sandoz, where he’s also a member of the Sandoz U.S. executive committee. Find out more at sandoz.com. That’s s-a-n-d-o-z.com. Tim, what’s happening with biosimilars in the U.S. market today, and how does this compare with other international markets?

Timothy de Gavre: So right now, there are 39 approved biosimilars in the U.S., and 24 have launched, which sounds pretty good, right? If you actually look at Europe, there have been 86 biosimilars launched in Europe, so the reality is we’re behind. Europe had the first biosimilar, as I mentioned at the beginning, in 2006, when Sandoz launched its biosimilar growth hormone. It took until 2015 for a biosimilar to launch in the U.S., and that was mostly as a result of the Obamacare passage in 2010, or the BPCIA, which enabled a pathway for biosimilars in the U.S. Europe has a head start on us, right? So there’s work to be done, and we also need to look at how we can reduce the barriers to acceptance of biosimilars in the U.S. and ensure that there aren’t structural elements of the U.S. health care system that inhibit the uptake of these products. The reality is they will save the U.S. health care system money, enable more investment in future innovations, and make the U.S. health care system more sustainable, and that’s something we should all get behind.

Kevin Pho: So it sounds like in Europe there are almost double the number of biosimilar medications, and one reason is because they have a head start. Are there any regulatory differences between the U.S. and Europe that would encourage them to have so many more biosimilars?

Timothy de Gavre: It’s a good question. I think that it’s just taken a little bit longer in the U.S. to get the engine going around biosimilar approvals. I think now we’re seeing that the FDA is really moving more quickly on biosimilars. One example is the adalimumab launch. There are going to be almost 10 biosimilars launching when adalimumab loses exclusivity next year. That’s an $18 billion drug, which is going to be huge for biosimilars. So we do see that it’s gaining traction. I will say, I think Europe is more familiar and more comfortable with biosimilars from an approval perspective. We also see in the U.S., quite often, some IP challenges in getting biosimilars to market, potentially some delays from that perspective. You have the famous patent dance with the BPCIA, which can sometimes limit or constrain the ability for biosimilars to launch. But we do see great progress in the U.S., and I’m hopeful that over the next few years, we could have as many as 120 new products launch.

Kevin Pho: You talked earlier about the impact on health care costs that biosimilars have for individual patients. Now, from a macroeconomic perspective, what’s the impact of biosimilars on health care costs, from a U.S. health care perspective?

Timothy de Gavre: Yeah, so if you look at generics, in 2021 alone, generics saved the U.S. health care system about $370 billion. Of that, biosimilars saved about 7 billion, and since 2015, they’ve saved about $15 billion for the U.S. health care system. The big opportunity as we look forward is that it could be almost or upwards of $185 billion by 2025. So there’s a huge opportunity as we go forward to save the health care system money. The potential is still kind of to be realized. I mean, we’re still contributing, right, to the overall health care savings, but if we get the good traction, if we get market acceptance, we do see that biosimilars could have a huge impact on health care savings by 2025.

Kevin Pho: You mentioned earlier that new biosimilars will be launching. Is the U.S. health care system prepared to support greater biosimilar adoption and uptake?

Timothy de Gavre: I come back to that point around the insurance companies and PBMs, right? We really will need, especially as we get into the retail space and products like adalimumab, to see the insurance companies get behind biosimilars and really push their acceptance. I think the concern that we all have is that the economics typically favor the reference product, and it can be difficult for biosimilars to gain traction. I’m hopeful, though, that as we go forward, that will change, and we will see biosimilar uptake. We will see biosimilar acceptance. We need to make sure we’re also educating physicians. Physicians are a huge part of this as well, so that they understand, as we talked about earlier, the difficult regulatory path these products need to go through, and that they can have confidence in the safety and efficacy of these products. That’ll go a long way also to supporting the uptake. I do think we have work to do, and the adalimumab LOE next year, when 10 products launch for this $18 billion product, will be a big test case. Are biosimilars able to get any uptake? What will happen with the reference products? How will insurance companies respond, and what will be physicians’ reactions?

Kevin Pho: So you mentioned that there are some things that physicians can do to help with the uptake of biosimilars. What are some examples of what individual physicians can do?

Timothy de Gavre: I think when a biosimilar launches, try putting some patients on it. Try getting some experience with biosimilars, right? It’s the right thing to do for our health care system, and it can be the right thing to do for your patients. And then, as physicians get comfortable with biosimilars, move more patients onto them, and let’s start getting market acceptance for these critical products. I think also it’s about really understanding the link between competition and innovation. If we don’t have competition, there won’t be future innovation. It’s by really challenging these existing products that we push companies to drive that future innovation. I think it helps if physicians understand that link and know that. Say you’re thinking, “OK, well, I’ve been using rituximab or trastuzumab for the past 15 years. Why should I talk to you about a biosimilar?” Well, it’s because if we start using those biosimilars, guess what? The companies will need to innovate. They need to come up with new products to drive their financials, so we’ll get that next round of innovation.

Kevin Pho: So I’m going to ask you next to look into your crystal ball. What do you think will be the U.S. biosimilar landscape in the foreseeable future?

Timothy de Gavre: As technology continues to improve, the clinical hurdles for biosimilars will likely go down. Right now, you do a lot of analytical work at the beginning to understand the structure. Then you do a phase one, then you do a phase three, and the phase three can be quite big. You do those phase threes in one indication, and then you extrapolate to other indications, assuming that it’ll have the same effect in other indications. As we get better at the analytical chemistry, and as the regulators get more comfortable, you may see fewer requirements around the phase three, and you may actually speed the approvals of these products. Right now, it can cost hundreds of millions to develop a biosimilar, and I’m hopeful that as we go forward, the costs get closer to what it costs to develop a generic, which can be 10 to 15 million. That will also then mean more products coming, more choices for physicians, more competition, and hopefully then that next round of innovation.

Kevin Pho: And my final question, Tim: What are some of your take-home messages that you want to leave with the KevinMD audience?

Timothy de Gavre: Look, I know biosimilars have a funny name, but I think you can all be comfortable that they have the same safety and efficacy as the reference products. They go through a really rigorous regulatory review. They are scrutinized and only brought to market when regulators are 100 percent certain that patients will benefit from these products. I think there’s also that link between biosimilars and innovation. If you’re investing in biosimilars, if you’re saving health care systems money, there are two really positive things, right? First, health care systems can afford that next round of innovation. The second thing is that competition will push companies to innovate. They’re going to need to find those new products that can then also benefit patients, improve patients’ lives, and extend patients’ lives. So biosimilars, although they’re copies, do drive innovation. They’re safe, they’re effective, they help make health care systems sustainable, and they will help drive that next round of innovations for patients and physicians.

Kevin Pho: Tim, thank you so much for sharing your time and insight. Find out more at sandoz.com. That’s s-a-n-d-o-z.com. Thank you so much for listening.

Timothy de Gavre: Kevin, thank you.