Keren Haruvi, President of Sandoz North America, reflects on the company’s transformation following its spin-off from Novartis and outlines how Sandoz is positioning itself at the forefront of the evolving US generics and biosimilars landscape. She discusses the structural barriers shaping market access, from PBM dynamics to patent complexity, while highlighting the company’s recent wave of launches and ambitious pipeline. Haruvi also shares her perspective on policy reform, investment challenges, and the critical role biosimilars play in expanding sustainable access to medicines.
How would you describe your career journey, and what state was the business in when you took over in 2021?
I have been in this industry since 2003, and my career has largely been shaped by roles in the financial and M&A space before transitioning into a more purely commercial role in my current position. When I first started at Teva, biosimilars were still in their infancy in the US. The first launch did not occur until 2015, when Sandoz brought filgrastim to market. At that time, this business was overwhelmingly focused on generics.
I joined Novartis in 2017 as Global Head of M&A, where I had early exposure to the Sandoz US business before moving into the role of President of Sandoz North America in 2021. I inherited a challenging situation shaped by decisions taken in response to the severe price erosion in the US generics market since 2016. The pipeline had been wound down in preparation for a potential divestiture of the US business, which was ultimately blocked by the Federal Trade Commission. When I arrived, I was effectively integrating a business in structural decline with no pipeline behind it.
I am proud to say those years are firmly behind us. By 2022, the generics business had stabilized, and since 2023, both generics and biosimilars have returned to growth. While generics remain a foundational part of the business, our strategy going forward places biosimilars at the center of our growth ambitions.
Since the spin-off from Novartis, what has truly changed in practice for Sandoz as an independent company?
Sandoz and Novartis were always somewhat distinct, even when formally integrated. On the back end, in areas such as manufacturing, compliance, and quality assurance, we were closely interconnected. However, from a commercial perspective, we operated with a high degree of independence. In many respects, the cultural and operational identity of the business was already differentiated.
And, it is important to remember that while yes, we are newly independent of Novartis, our heritage as an independent company goes back 140 years. In fact, this year we are celebrating simultaneously that 140-year anniversary, 80 years since we commercialized the first oral penicillin, and 20 years since we brought the first biosimilar to patients.
Where the spin-off has made the most tangible difference is in policy and intellectual property. These are areas where it is very difficult to be an effective advocate if you are part of a branded pharmaceutical company. Novartis was an excellent parent, but the reality is that a generics and biosimilars company needs to actively support patent reform, earlier market entry, and a more competitive IP landscape. Those positions are naturally in tension with the interests of an innovator company.
As a standalone organization, we are now able to take those positions more clearly and more consistently. I recently served as Chair of the Association for Accessible Medicines (AAM), and our Head of Europe has also served as Chair of Medicines for Europe. We are actively working to shape these markets on a global basis, because we believe it is our responsibility as a leading pure-play company in this space.
How do you assess Sandoz’s current impact on access, system-wide cost savings, and healthcare affordability in the US?
Estimated healthcare system savings delivered by Sandoz’s key products in 2025 stand at USD 10.6 billion in the US and USD 2.4 billion in Canada. More broadly, around 90 percent of all prescriptions dispensed in the US are for generic medicines, yet they account for just 12 percent of total drug spending. That represents a significant transfer of value to patients and the healthcare system, driven by decades of competitive market entry from companies like ours.
Over the past two years, we have meaningfully rebuilt our generic launch capabilities. The number of launches this year has more than doubled compared to last year, and our pipeline engine is now fully operational again.
In biosimilars, the opportunity is even greater, but so is the gap between potential and current reality. Today, biologics account for around 50 percent of total medicine costs while treating only about 5 percent of patients. What we want to see is a shift toward lower prices reaching a much broader patient population.
We see that kind of market expansion consistently in Europe. For example, following the loss of exclusivity for adalimumab, the market grew at double-digit rates year over year. In the US, however, prescriptions for adalimumab have declined since the loss of exclusivity in July 2023. That is the opposite of what we would expect in a competitive market, and it highlights one of the key challenges our industry still needs to address.
From your perspective, what are the most significant structural barriers shaping biosimilar adoption in the US today?
In the pharmacy benefit segment, pharmacy benefit managers (PBMs) are the dominant force, and their incentive structures have historically worked against biosimilar adoption. The recent Consolidated Appropriations legislation is a meaningful step in the right direction. It moves toward the kind of PBM reform that the AAM has long advocated, particularly around transparency. You cannot fix a system you cannot see clearly. The provisions related to rebate reform are also helpful. That said, it does not go far enough, and broader structural reform is still needed.
The scale of the misalignment is clearly illustrated by what happened with adalimumab at launch. Within six months of biosimilars entering the market, penetration was below two percent. The reason was that PBMs stood to lose an estimated USD six billion in rebate income if they switched patients to biosimilars. That is the kind of incentive structure that needs to be addressed.
In the medical benefit segment, the role of PBMs is less dominant, but the system remains highly complex. A product must navigate group purchasing organizations, specialty pharmacies, and individual physicians before it reaches the patient. Each of these stakeholders needs to be appropriately incentivized to choose a biosimilar over the originator, and the brand is often in a stronger position to offer those incentives.
One positive development is the average sales price (ASP) plus eight percent reimbursement differential for biosimilars under the Inflation Reduction Act (IRA), which improves the reimbursement dynamics for providers. However, more measures of this kind will be needed to drive meaningful change. Ultimately, what is clear is that when biosimilars and generics enter the market, prices come down; competition is the best way to achieve more affordable medicines in the US.
How would you characterize physician confidence in biosimilars today, and to what extent is adoption still driven more by system dynamics than clinical perception?
For the most part, physician education is not the primary barrier, at least in the specialties where biosimilars are already well established. Oncology is the clearest example. Within three years of launch, biosimilars typically reach around 80 percent market share in the US. Oncologists are very comfortable with these products, and their level of confidence is now comparable to how physicians view generics.
In newer therapeutic areas, there is naturally a longer education curve. Our recent launch of a natalizumab biosimilar, the first in multiple sclerosis, required more in-depth clinical discussions. That is expected and, in my view, more a matter of time than a fundamental barrier. Ophthalmology is another example of how quickly this can evolve. Retina specialists have become both clinically and financially comfortable with biosimilars in a relatively short period.
The more significant barrier in the medical benefit setting is not physician skepticism, but the complexity of the system. There are multiple intermediaries between the manufacturer and the patient, and each has its own incentives. Those incentives are not always aligned, and the originator often has greater financial flexibility to influence decision-making. That structural dynamic is where policy attention is most urgently needed.
Interchangeability has been a central topic in the US biosimilar debate. In practical terms, how relevant is it to commercial success across different care settings?
Its relevance really depends on the care setting. In the medical benefit, where products are administered in a physician’s office rather than dispensed through a pharmacy, interchangeability has very limited practical significance. The physician makes the prescribing decision directly, and the pharmacist is not involved. For products like denosumab, which are administered in-office, the interchangeability designation does not meaningfully influence commercial dynamics.
In the pharmacy benefit setting, interchangeability has more theoretical value, as it allows a specialty pharmacy to substitute a biosimilar for the originator without consulting the physician. However, in practice, its impact is often overstated. If you look at a product like adalimumab, many patients have been on therapy for years. Switching to a product that looks different, is packaged differently, and arrives without prior discussion with their physician is not a straightforward process. In our experience, physician involvement in the transition is a much stronger driver of uptake than pharmacy-level substitution.
The FDA has also acknowledged that interchangeability has, in many cases, functioned more as a marketing designation than a clinical one. It has created a perception that interchangeable biosimilars are somehow superior, which is not the case. We became the leading adalimumab biosimilar in the US before obtaining an interchangeability designation. That reflects where the real drivers of success lie, including established experience in Europe, the quality of the delivery device, and the strength of patient support services.
Sandoz had an exceptionally active launch year in 2025. What have you learned from bringing multiple biosimilars to market?
2025 was a landmark year for Sandoz in the US, with four biosimilar launches in a single calendar year. We launched our ustekinumab biosimilar in February, followed by our two denosumab biosimilars around June, and then our natalizumab biosimilar towards the end of the year.
The denosumab launch is particularly interesting because it is quite unusual. It is a single molecule serving two distinct patient populations through two separate products. On one side, you have oncology, where physicians are very familiar with biosimilars and where we already have a strong presence, having been the first company to launch a biosimilar in the US back in 2015. On the other, you have osteoporosis, which represents the first biosimilar in that therapeutic area and involves a very different prescriber base. A number of our initial assumptions about how those two launches would play out had to be revisited, and we learned a great deal through that process.
The denosumab experience also highlighted one of the less discussed barriers in this market, which is how the innovator chooses to compete. There is a meaningful difference between originator companies that allow the market to function after loss of exclusivity and those that aggressively reprice to biosimilar levels to limit switching. In some cases, that can reduce the immediate incentive to move to a biosimilar.
However, if you look at the historical pattern, innovators tend to lower prices when competition enters the market and raise them again when that pressure eases. Without biosimilars acting as a consistent competitive force, there is no mechanism to sustain lower prices over time. That is why maintaining a healthy level of competition in the market is so important.
Recent FDA guidance aim to streamline biosimilar development by reducing certain clinical requirements. How meaningful are these changes in practice?
They are genuinely welcome, and Sandoz has been advocating for these types of changes for some time. The global dimension is particularly important. Biosimilar development programs are inherently international, so greater alignment between the US and Europe significantly amplifies the impact. The fact that both regions are moving in a similar direction at the same time makes this especially meaningful.
From a scientific perspective, the removal of certain Phase III requirements is well justified. The industry has not seen biosimilars fail at that stage, which suggests that those studies were not adding meaningful evidentiary value. Reducing development requirements should help lower costs and enable companies to bring more products to market, including some that may previously have been considered commercially marginal.
That said, it is important to be clear about what these changes do and do not address. The main barrier to biosimilar development in the US has not been scientific or technical. In markets such as adalimumab or denosumab, there are already multiple competitors, which shows that the approval pathway itself is not the primary constraint.
The more fundamental challenges are market unpredictability and the complexity of the patent landscape.
There is growing concern around underinvestment in future biosimilar pipelines beyond just blockbuster products. What is driving this hesitation, and what needs to change to incentive more holistic development in the space?
It is a serious and well-documented risk. The recent IQVIA report highlights that around 50 biologics are expected to lose exclusivity over the next seven years, yet the pipeline of biosimilar candidates for those molecules remains alarmingly thin.
The underlying issue is a lack of investment predictability. Developing a biosimilar is a significant undertaking. Even with recent regulatory streamlining, the cost is still around USD 100 million per asset. That is not a decision companies take lightly. When you combine that with an intellectual property landscape that can effectively block market entry, the commercial rationale becomes much more challenging.
A good example is our etanercept biosimilar. We received approval in 2016, but a US court upheld patent protections that effectively delayed launch until 2029. That kind of outcome makes it very difficult to justify the level of investment required, because the return becomes highly uncertain.
As a European-based company, Sandoz is somewhat insulated because we can generate returns across a broader global portfolio. Many US-based competitors do not have that same flexibility. In my view, the current gap in the pipeline reflects a rational response. Companies are understandably hesitant to invest USD 100 million in a product when the timing and viability of a US launch remain unpredictable.
Ultimately, this points to the need for structural change. Patent reform is a key part of that. Without it, the risk of underinvestment will only increase over time.
How would you characterize the current US patent landscape for biosimilars, and what would meaningful reform need to address to create a more predictable environment?
The US patent landscape is both highly complex and unpredictable. Over time, originator companies have been able to build very dense patent thickets. In the case of adalimumab, for example, more than 100 additional patents were filed in the year leading up to loss of exclusivity. As a biosimilar company, you may successfully challenge a number of patents, only to face additional layers of patents immediately afterwards. It becomes, by design, a process of attrition.
In the generics space, we refer to this as serial patent litigation, and we have experienced it directly. We were the only company willing to pursue a 2022 launch for one product where all other competitors had settled for entry many years later. We launched at risk and were alone in the market for just ten days. The financial return from that effort was minimal, and what followed was another wave of litigation. That experience illustrates the broader issue. The current system does not reward companies for taking that kind of risk, which reduces the incentive to challenge these barriers.
I want to be clear that I have a great deal of respect for intellectual property as a driver of innovation. It plays an essential role. However, there is an important distinction between protecting true innovation and extending exclusivity on a mature molecule for decades. Our role as a biosimilars industry is to support innovation by increasing access and freeing up resources for the next generation of therapies.
Meaningful reform would focus on limiting the ability to build and maintain these extensive patent thickets. Without that, it becomes very difficult to sustain a competitive market, and that ultimately affects both access and long-term innovation.
With a significant wave of biologic patent expiries ahead, how is Sandoz positioning itself to capture a “golden decade” for biosimilars?
The patent cliff that many view with concern, we see as a generational commercial opportunity. Over the next decade, we are looking at around USD 300 billion in biologic loss-of-exclusivity events. The scale of that opportunity is unprecedented.
Positioning ourselves to capture it has required us to address a key structural limitation. Until now, all of our biosimilar manufacturing has been conducted through Novartis. That changes this year, with the opening of our own fully integrated, state-of-the-art biosimilar manufacturing facility in Lendava, Slovenia. We will continue to use third-party manufacturing where appropriate, but having our own dedicated capability is an important step in operating as a standalone biosimilar company.
Our pipeline reflects that level of ambition. We currently have 10 biosimilars on the US market, and that number will continue to grow. We have publicly disclosed 27 pipeline assets, and our partnership with Samsung Bioepis adds a further five, bringing the total up to 32. Bringing that volume of products to market requires strong alignment across development, regulatory, manufacturing, and commercial functions.
The appointment of Armin Metzger to lead this integrated effort is focused on ensuring we have the right leadership in place to execute at that scale. From a US perspective, the commercial structure remains unchanged. What this represents is a broader operational alignment behind the scenes, designed to ensure we can bring our pipeline to market with the speed and consistency that this opportunity demands.
Looking at the pipeline and the market ahead, what are you most excited about and where do you see the most important work still to be done?
I am genuinely excited about the entire pipeline. What I find most important as we continue to scale is how biosimilars establish a sustainable commercial model in the US. Today, biosimilars are often treated like branded products from a service and support perspective, with extensive patient programs, device support, and reimbursement services. That approach has been important in building early trust and driving adoption, but it is not sustainable at scale. It also puts pressure on margins in a way that can ultimately work against the broader goal of improving access.
As we bring more products to market, the key question is how to focus on the services that truly make a difference for patients, rather than replicating the full branded model by default. Patients can be well served by biosimilars that provide the right level of support at a meaningfully lower cost. Finding that balance is critical.
Our natalizumab biosimilar is a good example of where the access argument is most immediate. We are currently the only company offering a biosimilar in multiple sclerosis, which means there was no alternative for patients before our entry. That is, in many ways, the clearest example of what this industry is meant to deliver. Our responsibility is to ensure patients have access to the medicines they need, when they need them, at a more sustainable cost.
Finally, the recent Section 232 has granted tariff exemptions for generics and biosimilars. What does this say about how policymakers understand the value of the off-patent industry?
It is a win for patients. The tariff discussion was something Sandoz was very actively engaged in and working closely with AAM. Our message to the administration was very clear that tariffs on generics and biosimilars would lead to drug shortages.
The announcement on April 2nd 2026 that generics and biosimilars would be excluded from tariffs, at least initially and subject to reassessment, showed that the administration was listening. While the sustainability of this industry should not depend on such exemptions, in the current environment it is a very positive outcome, and one I am genuinely grateful for.
More broadly, the exemption signals an important shift in how the administration views the pharmaceutical landscape. There is now a clearer recognition that the branded pharmaceutical industry and the off-patent sector operate under very different dynamics, with different economic realities and different roles within the healthcare system. The generics and biosimilars industry does not face a pricing problem in the traditional sense, but rather a question of long-term market sustainability.
The focus now is on building a constructive policy dialogue that reflects that distinction. I was recently in the White House for a roundtable discussion on sustainability and supply chain resilience, and those conversations give me confidence that there is a meaningful level of engagement.
I want to end with the message that generics and biosimilars are part of the solution. We need a more predictable patent environment, market structures that allow products to reach patients, and continued policy support. At its best, the biosimilars industry is one of the most effective ways to expand access to high-cost medicines at scale, and we remain committed to delivering on that promise.
