Joshua Salsi, Head of North America, Biocon Biologics explains the company’s evolution into an integrated, global biosimilars company following the 2022 Viatris portfolio reacquisition. He highlights the company’s growing US leadership, expanding pipeline, vertical integration, and focus on patient access. Salsi goes on to stresses that long-term biosimilar growth depends on sustainable economics, regulatory modernisation, competition and stronger stakeholder collaboration.
Biocon Biologics sits within the broader Biocon Group alongside several distinct businesses. Could you outline its position within the Group and explain the strategic significance of the 2022 reacquisition of the Viatris portfolio?
Think of Biocon as the holding company overarching several distinct entities. Syngene is our pure-play, globally focused R&D and CDMO business. Bicara, based in Cambridge, Massachusetts, is a biotech company developing novel head-and-neck cancer therapeutics through bispecific antibodies. The two other core entities are our Generics business and Biocon Biologics itself.
Historically, Viatris served as our commercial and regulatory front end, while Biocon handled R&D and manufacturing on the back end. In 2022, Biocon reacquired those products from Viatris in what became the transformative transaction that formally establishes Biocon Biologics as an integrated entity, which now operates across 120 countries. The most accurate way to describe the organization today is spanning from lab to patient. We have full R&D and development capabilities through seven global manufacturing sites that support the substantial commercial growth we have built over the past several years. This is particularly true here in the US and North America, which is where my team and I came into the picture.
You joined as the inaugural head of the North American region, which was only formally established in 2024. What does the US market represent strategically for Biocon Biologics, and what was your mandate coming in?
My team and I have actually been part of Biocon’s biosimilars business since its inception, and most of us came over through the Viatris reacquisition. Before Biocon, I was at Mylan, which became Viatris, and my team led biosimilar launches from the very beginning. This started with our first pegfilgrastim biosimilar, Fulphila, in the US and continued through every launch since. So while building out Biocon Biologics’ standalone US presence was new, my team’s experience commercializing these assets was not. We have been a constant through the entire evolution of this biosimilar portfolio.
The US, and North America broadly, is a significant contributor to Biocon Biologics. This market will always be a pillar for any pharmaceutical company, whether generic, biosimilar, or branded. With nine biosimilars currently on the US market, several of them category leaders competing directly against long-established players, we’ve built a stronghold here that meaningfully contributes to both the Biologics P&L and the wider Biocon holding company.
One further development worth flagging is this past March, Biocon fully integrated Biocon Biologics Limited as a wholly owned subsidiary into Biocon Limited. This folded its generics business, including the GLP-1 portfolio, into the same structure under the Biocon Biologics umbrella for my region and globally. That was a strategic move to capture synergies, improve cost efficiency and capital allocation, and speed up time to market.
The ustekinumab biosimilar was Biocon’s first US launch conducted entirely under its own banner. What did the launch reveal about succeeding in such a competitive market, particularly as the company established its own identity beyond Viatris?
Yesintek was our first launch as a fully standalone organization under Biocon, and that mattered because it let us maximize vertical integration in a market as competitive and fragmented as the US. This is a capability we value enormously and lean on heavily when commercializing an asset.
Launching in the US requires evaluating customers, channels, stakeholders, competitors and the reference manufacturer all together. Ustekinumab biosimilars entered a genuinely competitive landscape with the reference manufacturer pushing back on multiple fronts, private-label offerings emerging from PBMs, and considerable divergence in list pricing across competitors. Bringing all of that together requires real scenario planning, and critically, we make that go-to-market decision at the individual asset level, not the therapeutic category or biosimilar-class level. That approach, combined with our vertical integration and strong commercial relationships, helped us secure strong formulary coverage early, which our commercial team then converted with providers. And the results speak for themselves. We have achieved roughly 25 percent of overall market share and over 40 percent of the biosimilar-converted market so far, and we expect that to keep growing.
With eight globally commercialized biosimilars and a pipeline of roughly 20 assets, how do you prioritize therapeutic areas and where do you see the greatest opportunities?
Like how we approach commercialization asset by asset, we believe pipeline development deserves that same granularity. A decade ago, it was fairly simple: look at IQVIA sales data, identify the largest biologic assets, and build your pipeline around them. Today, the market is considerably more complex and simply chasing the asset with the highest globally generated revenue isn’t necessarily the right opportunity for any given organization, particularly in the US. Instead, we look at our internal capability across R&D, manufacturing, and commercial, where a given asset fits within our broader portfolio, and what the competitive landscape will look like by the time it actually reaches market. We consider how many competitors there are, how pharmacy-benefit and medical-benefit dynamics are diverging in the US, which channels and customers we will be working with, and how the reference manufacturer is likely to compete once biosimilars enter that category.
For Biocon Biologics, we are actively looking at where we can genuinely differentiate ourselves. Our near-term pipeline includes a pertuzumab asset currently under FDA review, and we have publicly flagged nivolumab and pembrolizumab biosimilars as significant oncology molecules that multiple players will compete around. We have also made public our Hylauronidase platform, which we see as a key differentiator. Since we don’t expect many organizations to be able to replicate it, it opens the door to a range of future biologics we may eventually fold into the broader portfolio.
Oncology has historically been, and will remain, a mainstay for us given both our current portfolio and growing asset base. Insulins are our differentiator and have been part of our DNA since Kiran Mazumdar-Shaw founded the company. They will of course stay central to our business. Immunology continues to see strategic launches like adalimumab and ustekinumab, and further assets in our later-year portfolio will come about as they make commercial sense. We have now entered ophthalmology as well. Alongside our internal development, Biocon has built a robust commercial engine that keeps us open to inorganic growth through business development too, so we are well positioned to grow on both fronts.
What is Biocon Biologics’ unique competitive advantage in a landscape where being first to market does not necessarily guarantee long-term leadership?
When we first commercialized pegfilgrastim, eight years ago, our commercial team consisted of about 20 people, and Amgen was still generating roughly USD 4 billion annually from the product. Today, we are the market leader in pegfilgrastim (Fulphila), one of the leaders in trastuzumab (Ogivri), the leading insulin biosimilar manufacturer, and we have proven our position in immunology through ustekinumab. We also have multiple additional products moving through various launch stages and a robust pipeline in development. Kiran and the Biocon leadership team have built the infrastructure for us to be a sustainable player over the long term.
Our focus stays on the patient, on access and affordability, and on being the biosimilars partner our customers choose. Plenty of companies do many things, but biosimilars is what Biocon Biologics does. It is in our DNA and our entire organization is built around that specific expertise. Having spent considerable time earlier in my career on the innovator side, I would say the future of healthcare isn’t only about discovering what is scientifically possible, it is equally about ensuring patients can actually access it. That is precisely where we come in.
At the same time, access only works through the collective, sustainable effort of all stakeholders: patients, providers, health systems, payers, policymakers and manufacturers. Because the US market is so complex, with so many stakeholders touching each unit of product from manufacturing through distribution to coverage, we all have to be aligned. Biocon Biologics has a clear role to play in that as well.
Biosimilars have now been available in the US for roughly a decade, yet education is a topic that continues to come up in conversation. How much of that challenge persists, and how important has building Biocon Biologics’ own reputation been alongside broader market education?
The reputation question comes first. This is a diverse competitive landscape with established branded pharmaceutical, large generic, and biotech companies all doing biosimilars. Trust and credibility are essential, and it has to be earned. One of my central priorities leading this organization has been establishing Biocon Biologics as a trusted partner built through consistent reliability. That way, when other factors are equal, people choose to work with us because of what our name represents.
Everyone already knows names like Amgen and Teva, and we have had to build that same presence from a much lower starting point. Over the past several years, we have gone from a name rarely recognized in most US circles to a household name in biosimilars. Biocon Biologics is the market leader in pegfilgrastim, one of the top two in trastuzumab, and effectively the leading insulin biosimilar company. This is a trajectory that traces directly back to how Kiran Mazumdar-Shaw, founded the organization.
On education specifically, it varies by category. Oncology has reached a high level of comfort with biosimilars now. Going back roughly eight years, the pegfilgrastim launches moved that needle considerably, and questions about biosimilars have steadily dissipated as the space matured from supportive care into curative-intent treatments. Immunology is getting to a good place too, as usage of biosimilars continues to increase and additional data is released. Ophthalmology is newer territory for us. With the first biosimilar entrant being only the past year and a half to two years, our aflibercept biosimilar, Yesafili, has naturally drawn more questions around clinical data and reliability, which is still a fairly typical provider reaction to a new category. So yes, there is still some educational work to do, but it’s situation specific. We continue that work directly with both governing bodies and patient advocacy organizations as patients themselves often have important questions too.
The US continues to lag Europe in biosimilar uptake. How significant are recent regulatory developments, like the FDA issuing draft guidance to reduce unnecessary clinical pharmacokinetic testing, signalling a tipping point in biosimilar focus?
Biosimilars remain a relatively high-stakes business with substantial upfront investment, significant cash outlay, and considerable time to bring an asset to market. All of these investments require a sustainable marketplace to justify. The work Sarah Yim, the director of Office of Therapeutic Biologics and Biosimilars, and her team at the FDA, has done around comparative efficacy trials reduces both the upfront R&D investment and the time to market, since it removes the need for that Phase III trial component entirely. Plus, legislation like the BIOSIMILARS Red Tape Act, which addresses the challenging interchangeability requirements, matter considerably if they can cross the finish line. That means more drugs reaching market faster, which is a clearly positive step. Furthermore, these developments could open the door to new entrants who see biosimilars as more viable, which in turn drives more competition, and ultimately, greater downstream access.
On the flip side is market sustainability. To me, the two are inseparable. We can reduce upfront investment and open faster regulatory pathways all we like, but none of it matters without a sustainable marketplace for these products to actually launch into. Without it, you get consolidation and declining biosimilar value instead.
We have all seen the numbers: USD 56 billion in savings by 2025, which has been largely concentrated in just the past few years. At the same time the “biosimilar void” data showing 118 reference products coming off patent over the next decade with only 12 currently in development. Getting that number higher requires more than a single policy or regulatory change. It has to be a collective effort across providers, patients, manufacturers, payers and policymakers who are all moving together. Viability can be undermined from multiple directions at once, and once companies start pulling back investment rather than leaning into it, that is a very difficult position to recover from.
Beyond regulation and development costs, what structural barriers still need to be addressed to create a sustainable US biosimilar market?
A few come to mind. First, and we continue working through key challenges, like the Inflation Reduction Act’s (IRA) Maximum Fair Price (MFP) component, with the Association for Accessible Medicines (AAM) and the Biosimilars Forum. We don’t want regulation effectively replacing competition, but if that pricing pressure lowers the ceiling for the innovator product too far, it squeezes the very opportunity a biosimilar needs to enter that category. I am not saying what the IRA set out to achieve on access and affordability is wrong, but certain mechanics like MFP have introduced real pressure that needs rebalancing.
PBM reform is another one that is been discussed in Washington for some time now. We are seeing some positive momentum as with this year’s Consolidated Appropriations Act, though it can’t be the sole fix. As a sector, we still need market access, sustainable reimbursement, and the regulatory modernisation working in parallel.
A further, more conceptual point that matters enormously to me is the idea of becoming biosimilars-first minded. How do we get to a place in the US market where once a biosimilar is available, it applies real downward competitive pressure on the reference product and makes it harder for the originator to compete in that category? Other markets do this differently like with tender-based systems in parts of Europe and provincial-level switch initiatives in Canada. While no single model is the answer for the US, one piece we discuss often is limiting the sheer number of patent references manufacturers can assert. Settlement negotiations around those patents add significant time and cost to biosimilar entry.
Beyond that, how do we actively incentivize biosimilar utilisation, whether through value-based or shared-savings arrangements, or something else entirely? We don’t have the final answer yet, but biosimilars have now proven their value with real data behind them. The natural next step is to embrace that biosimilars-first principle while recognizing the nuance between medical and pharmacy benefit, and between therapeutic categories, since none of this plays out identically across the board.
Are the recent discussions around potential tariffs on generics and biosimilars something that is being considered in Biocon Biologic’s long-term planning?
It is something we always have to stay on top of and weigh carefully. Continuing to operate effectively within US market infrastructure remains critical to what we do. For us, this is an evaluative exercise in understanding what different scenarios could mean, staying ready if any of it materializes, and not overreacting to signals before they become policy. If it does ultimately affect how we operate, we will adapt our approach to the US market accordingly.
I will say that there must be guiding principle around any of these kinds of conversations. If the patient truly sits at the center of access and affordability, every decision, tariffs included, has to be weighed against that outcome first.
What specific priorities would you flag for the next two to three years, and what would genuine success look like as this market continues to mature?
For Biocon Biologics specifically, it comes down to firmly establishing ourselves as a trusted, long-term partner, and I don’t use that word lightly. I want Biocon Biologics to be one of the first names mentioned when you ask stakeholders across the US about the top biosimilar companies globally. That is what we are working toward across the broader market too by helping shape the policy conversation. We have had genuinely positive momentum recently, and the question now is how we build on it. To use a football analogy: we have strung together a series of first downs and the real opportunity ahead is turning that into the touchdown. While there is still work to be done in the US biosimilar space, we are not going anywhere. We are very much open for business and pleased with our continued growth quarter over quarter.
What final message about biosimilars would you like to leave the healthcare and life science community with?
The more visibility this space gets, the better positioned we all are. Biosimilars occupy a hybrid market position, part generic-style contracting given how many highly similar competitors exist, and part branded pharmaceutical, with real commercial infrastructure, patient hub services, and support programs. It sits somewhere distinctly in between, and the more clearly that gets communicated, the better it is for the long-term sustainability of these businesses.
