Europe pioneered the biosimilars industry and remains its most advanced market, yet sustaining that leadership is becoming increasingly challenging as pricing pressures, manufacturing economics and global competition reshape the sector. As Formycon reaches a pivotal stage in its evolution, CEO Stefan Glombitza discusses the company’s transformation into a globally oriented pure-play biosimilars specialist, the strategic choices underpinning its growth, and why disciplined execution will determine the next generation of industry leaders.
What has shaped your career in the pharmaceutical industry, and what led you to Formycon?
I have always been fascinated by how medicines work and the difference they can make to patients’ lives. That curiosity led me to study pharmacy at the University of Regensburg, followed by a PhD in physiology, with a particular interest in the medical and pharmacological side of medicines. I joined Hexal in 1995 as a Medical Affairs Manager because I was drawn to generics and the opportunity to improve affordability and access for large numbers of patients. Coming from a down-to-earth family, that sense of making a tangible difference was important to me, and it has remained the common thread throughout my career in the off-patent medicines industry.
Hexal was an extraordinary place to learn. Under the leadership of Andreas and Thomas Strüngmann, I experienced a highly entrepreneurial culture under which one of Germany’s leading generics companies was built, and I learned a great deal from their ambition, speed and approach to building a business. Following Novartis’ acquisition of Hexal in 2005 and its integration into Sandoz, my responsibilities became increasingly international. I went on to lead global project and portfolio management across eight development centres, overseeing approvals and launches in around 70 countries each year. Those two decades gave me invaluable experience, both in global development and in leading increasingly large and diverse teams.
After 20 years, I was looking for two things. I wanted to move from small molecules into biologics, because I believed they represented the future of treating severe diseases, and I wanted to return to a smaller, more entrepreneurial environment where I could help shape a company’s growth. That brought me to Formycon as Chief Operating Officer in 2016. Together with our teams, we strengthened our development capabilities, advanced three biosimilars from our pipeline to approval and international commercialisation, and established a development platform with a strong reputation in the biosimilars field. When my predecessor stepped down in 2022, I had the privilege of becoming CEO, and today my focus is on building on that foundation as we continue to grow Formycon.
What distinguishes Formycon within today’s biosimilars landscape, and how does that focus influence your portfolio strategy?
Biosimilars are one of the strongest tools we have to democratise medicine because they expand access to highly effective biological therapies while helping healthcare systems manage costs. It is still a relatively young and dynamic market with significant long-term potential, and companies have taken different approaches to participating in it. Many have built their biosimilars business on a generics foundation, while others combine biosimilars with innovative biologics. Our approach has always been different. We have deliberately chosen to remain a pure-play biosimilars company because we believe that focus gives us a real competitive advantage.
For us, moving into generics would make little strategic sense. Companies that started in generics naturally evolved into biosimilars, but we are already operating in a segment with stronger margins, greater growth potential and an attractive long-term outlook. Equally, while we have explored innovative biologics and possess some of the underlying scientific capabilities, the organisational mindset is fundamentally different. Biosimilars require scientific excellence, but they also demand urgency, agility, disciplined execution and speed to market, whereas innovative biologics involve much greater scientific uncertainty, longer development pathways and a different approach to portfolio management. I experienced that contrast firsthand during my career, and it convinced me that combining those cultures is not straightforward. Remaining focused allows us to concentrate our expertise, resources and way of working entirely on biosimilars, and it has taken many years to build that expertise.
The same philosophy shapes our portfolio. We currently have seven biosimilar programmes, with three products already commercialised or entering commercialisation and four more progressing through development. The most advanced from our development stage pipeline is FYB206, our proposed biosimilar to pembrolizumab (Keytruda®), which has demonstrated pharmacokinetic equivalence with the reference product and is now moving towards regulatory submission. Given the importance of Keytruda in oncology and our position among the front-runners, we believe this programme has the potential to become a significant growth driver for Formycon. At the same time, every euro we generate is reinvested into expanding the pipeline, and we expect to initiate three additional development programmes this year.
Choosing those programmes is probably one of the most important decisions we make because each one requires an investment of well over EUR 100 million, while the decisions themselves must be made around a decade before the product reaches the market. Every year we carry out a rigorous cross-functional portfolio selection procress, bringing together scientific, medical, intellectual property and commercial expertise, supported by external market intelligence, to assess which assets are most likely to succeed as medical first-line therapy over the long term. The objective is to maintain a balanced portfolio of major blockbusters and what we call “NicheBusters”. Blockbusters provide access to very large markets but inevitably attract more competition, while NicheBusters address smaller markets where competition is typically lower and pricing more stable. We are certainly not moving away from blockbusters, but in case we go for a blockbuster molecule, we have to make sure that we create a position, among the front-runners and as part of the first wave to reach the market. This is a prerequisite for those programms to create significant value.
Where does Formycon stand today in its evolution, and what milestones best reflect the company’s transformation?
We are at a real inflection point as a company. We are transitioning from a pure-play development platform into a sustainably growing global biopharmaceutical company, combining increasing profitability with a continually expanding pipeline. Biosimilars remain an attractive business, but they are by no means an easy one. Success ultimately comes down to setting the right direction and executing consistently, which is exactly what our FYB4Growth strategy is designed to do. What gives me confidence is our ability to execute, because strategy alone is never enough. It is the quality of our people, their expertise, agility, urgency and commitment, that gives me confidence we can adapt to the demands of the dynamic Biosimilar space and deliver the next stage of Formycon’s growth.
That evolution was reflected in our uplisting to the Prime Standard at the end of 2024, which I still remember through the sound of the opening bell. For us, it represented far more than a capital markets event. It marked the point at which Formycon had evolved from a relatively small biosimilar developer into a recognised development platform with a strong reputation across the industry. By then, we had one product commercialised in around 20 countries, two further biosimilars approved or about to be approved by the EMA and FDA awaiting launch, and a solid foundation for our next phase of growth.
That made it the right time to broaden our international shareholder base, increase our visibility among institutional investors and demonstrate that we were ready to meet the highest standards of transparency and governance. Like preparing for an FDA inspection, reaching the Prime Standard requires considerable preparation, and we wanted to ensure every element was in place before taking that step. Looking back, it was a natural milestone in Formycon’s evolution and the right platform from which to pursue our long-term growth ambitions.
How does Formycon’s partnership-driven commercial model support its long-term growth strategy?
Our model today is deliberately capital-light and business-to-business. We focus on what we do best, which is developing complex biosimilars, while partnering with established pharmaceutical companies for commercialisation. That enables us to combine our development expertise with strong local execution and global reach, without having to build our own commercial organisation in every market. Our partners bring established relationships with healthcare providers, payers and local authorities, while we coordinate the broader international strategy. Over time, we have also moved away from global licensing agreements towards specialised regional and local partners. That inevitably adds complexity, but it also allows us to maximise the reach of our products by working with companies that truly understand their local markets. Biosimilars are not commercialised in the same way everywhere, and differences in regulation, market access, procurement and tendering make local expertise indispensable. It would simply not be realistic to manage commercial execution across dozens of countries from our headquarters near Munich. Our long-standing partnership with MS Pharma illustrates that approach well, combining regional market knowledge, established commercial networks and local biologics manufacturing capabilities to support successful launches across the Middle East. More broadly, this model allows us to expand much faster in markets outside the US and Europe, where biosimilars have an important role to play in improving access to biological medicines.
Looking ahead, I see partnerships remaining at the heart of our strategy because they allow us to stay focused on our core strengths while continuing to scale internationally. Over the longer term, I can certainly envisage building our own commercial capabilities in selected markets where it makes strategic sense, but that is not where our priorities lie today. Instead, we are adding new capabilities that should remain under our direct control, particularly our central supply chain, which enables us to support a growing network of commercial partners around the world while managing complexity in a coordinated and efficient way.
What role do Europe and Germany play in Formycon’s long-term strategy, and what will it take to keep Europe globally competitive in biosimilars?
Europe’s positioning varies across different stages of the value chain. From a regulatory perspective, it has been the global pioneer in biosimilars, establishing the first dedicated scientific and legal framework and setting the benchmark that continues to shape biosimilar development worldwide. Even today, the EMA remains one of our preferred regulatory authorities because of the quality of the scientific dialogue, the predictability of its procedures and the reliability of its timelines. That said, we do not see this as a choice between Europe and the United States. For all our programmes, we need approvals from both the EMA and the FDA, as together they present the key Biosimilar markets and they provide the strongest regulatory foundation for subsequent submissions in many international markets, where national authorities frequently rely on these reference agencies as part of their own assessments.
Manufacturing presents a very different picture. Europe rightly wants to preserve pharmaceutical manufacturing and the associated know-how, but that ambition has to be matched by an economic framework that makes it competitive. Biosimilars require investments of well over EUR 100 million per programme, and those investments cannot be sustained if procurement is driven solely by the lowest price. We have already seen much of the generics supply chain move to Asia for exactly that reason. There is a real risk of repeating the same pattern in biosimilars unless Europe creates the right incentives for local manufacturing or new technologies significantly improve cost competitiveness. If we want manufacturing to remain in Europe, sustainable pricing has to be part of the discussion.
Formycon is a German company based in Munich biotechnology cluster. The fact that we are able to stand competition against international players, makes me proud. Our headquarters and laboratories in Martinsried remain our sole site, and I believe that will continue to be the case for the next couple of years. We are firmly rooted here, carrying out our core development activities locally, while thinking globally, interacting with international partners in developing products with international reach. Germany, and Munich in particular, also continues to attract outstanding talent from around the world. Today, our teams represent 27 nationalities, which gives us a truly international perspective while keeping our scientific and operational centre firmly in Germany.
More broadly, I believe Germany has everything it needs to create more globally successful biotechnology companies, but it requires the right political framework and, equally importantly, the right mindset. There are tremendous opportunities, and we should spend less time focusing on what we cannot change and more time acting on what we can influence and create. For me, leadership is not about having every answer; it is about building an organisation that learns, adapts and responds quickly as markets evolve. That agility is becoming a prerequisite for long-term success, because pricing, competition and market dynamics will continue to change, and companies that thrive will be those that evolve with them.
What are your key priorities as Formycon enters its next phase of growth?
We have set out a clear strategy, but strategy only provides direction; ultimately, trust is earned through consistent execution. My immediate priority is therefore to ensure seamless execution across the pipeline we have today, particularly our Keytruda biosimilar programme, where maintaining our frontrunner position remains a major focus. At the same time, we need to continue strengthening our portfolio through disciplined asset selection to support the next stage of growth, while further establishing Formycon as the partner of choice for the global biosimilars community. We have built a strong reputation over many years and preserving it will require disciplined execution and a continued focus on expanding our portfolio.
What gives you confidence in Formycon’s future and its ability to deliver on that ambition?
Everything starts with people. Biosimilar development requires scientific excellence and deep experience because these are highly complex molecules, but I have always believed that success comes from the combination of skill set and mindset. Alongside expertise, you need the agility to adapt, the willingness to embrace uncertainty and the openness to recognise and seize new opportunities as they arise. My role is to provide the direction and create the framework that enables talented people to grow, because over the past 30 years I have learned that, when you create that environment, people and teams are capable of achieving remarkable things.
That is why I believe Formycon is at such an important inflection point. We are evolving from a highly respected development platform into a globally oriented, growing and sustainably profitable biosimilars company, and I believe we have the right ingredients in place: the right people, a clear strategy and the determination to execute. Looking ahead, it is the combination of our pipeline and our people that gives me confidence that the most exciting years for Formycon are still ahead.
