Against a backdrop of rising geopolitical tension, regulatory fragmentation, and mounting pressure on Europe’s healthcare systems, Prague-headquartered Zentiva is positioning itself as a distinctly European pharmaceutical player focused on long-term resilience, affordability, and supply security. CEO Steffen Saltofte reflects on the company’s transformation since its carve out from Sanofi, its expanding role in generics and biosimilars, and the broader reforms he believes Europe must embrace to preserve its pharmaceutical competitiveness and healthcare sovereignty.
What have been the main drivers behind Zentiva’s transformation since becoming independent in 2018?
Zentiva became independent again in 2018 after Advent International acquired and carved out Sanofi’s European generics business in a EUR 1.9 billion deal, marking the beginning of a significant transformation for us as a business; this journey recently took another step forward as we moved under new ownership with GTCR. Today, we operate as a standalone European pharmaceutical company with 5,400 employees serving more than 100 million people across the continent. Our focus remains entirely on Europe, spanning development, manufacturing, and commercial operations, with four manufacturing sites across the Czech Republic, Romania, and India supported by a broad network of external manufacturing partners. That “from Europe, for Europe” positioning remains central to who we are and how we operate. For us, success is ultimately measured through the contribution we make to patients and healthcare systems. With generics accounting for roughly 70 percent of medicines dispensed in Europe, we see ourselves as the backbone of European healthcare, carrying a major responsibility in ensuring accessibility, affordability, and availability of medicines
Over recent years, we have continued to expand both organically and through targeted acquisitions while maintaining a strong launch cadence and broadening our presence in new therapeutic areas. A good example is the acquisition of Apontis Pharma, particularly because of its focus on single-pill combinations in cardiovascular disease. By combining several off-patent active ingredients into one daily treatment, the approach can improve adherence and patient outcomes while also reducing healthcare costs and system complexity. More broadly, despite a rapidly changing external environment, we have continued to grow by staying focused on execution, operational resilience, and patient access rather than ownership structures or market noise. For us, the priority remains building a sustainable long-term business capable of consistently delivering medicines to patients across Europe.
How do you view the opportunities and challenges associated with a “from Europe, for Europe” pharmaceutical model?
I genuinely believe pharma remains one of Europe’s strategic strengths. When you look across generics, consumer healthcare, and innovative medicines, Europe still has an exceptional concentration of expertise, industrial capability, and heritage that very few regions can match. In our case, Zentiva’s roots go back more than 500 years through the historic Black Eagle pharmacy in Prague, and that long-term perspective is still very much part of who we are today. We have been here for centuries, and we intend to continue serving patients in Europe for many more. At the same time, the environment has clearly become more challenging, particularly for generics, because Europe remains a highly regulated market with constant pricing pressure. Despite that, I still see a lot of positives. We were recently in Brussels speaking with the European Commission and the Health Emergency Preparedness and Response Authority (HERA), and there are encouraging discussions taking place around medicine shortages, supply resilience, and the Critical Medicines Act. There is a growing recognition that pharma is not only important for healthcare systems, but also for Europe’s broader competitiveness and sovereignty.
That said, the operational reality remains extremely complex. Our job, fundamentally, should be very simple: making sure patients receive the right medicines at the right time. In practice, however, we are dealing with geopolitics, fragmentation, and 27 different national systems across what is supposed to be a single European market. The pricing framework we operate under was designed more than 30 years ago for a completely different economic environment and has become increasingly difficult to reconcile with today’s inflationary pressures and supply chain realities. In some markets, we are selling life-saving medicines for just a few cents under highly regulated pricing systems, while the wider cost base around manufacturing, energy, and logistics continues to rise. Over time, that creates real pressure on economic sustainability and, ultimately, risks impacting medicine availability and supply resilience across Europe.
I also think some well-intentioned policies can create unintended consequences if they are not properly coordinated. We fully support the environmental agenda and have invested heavily in environmental sustainability across our operations, including renewable energy and broader ESG initiatives, but measures such as fragmented national stockpiling requirements can create inefficiencies that work against both sustainability and European solidarity. If larger countries require significant national inventories, the industry simply cannot expand manufacturing capacity overnight without affecting supply elsewhere, particularly in smaller European markets. At the same time, because packaging and leaflets remain country-specific, medicines often cannot be redistributed efficiently across borders and may ultimately need to be discarded if unused. For us, the issue is not the ambition behind these policies. The ambition is right. The challenge is making sure Europe creates a more practical and coordinated framework that properly balances sustainability, competitiveness, and long-term healthcare resilience while allowing us to stay focused on delivering medicines to patients.
Where do you believe Europe still needs to act to strengthen the long-term competitiveness and resilience of its pharmaceutical sector?
I would give the European Commission and the broader EU system some credit because there is clearly a growing recognition that pharma matters not only for healthcare, but also for Europe’s industrial base, competitiveness, and long-term resilience. That applies across the sector, from generics to innovative medicines. Europe still has an exceptional foundation in research, clinical development, manufacturing, and medicine innovation, and we need to preserve that strength. When you look at the level of clinical research, scientific capability, and industrial expertise that already exists here, there is a great deal worth protecting and continuing to build on, and I do think there is a genuine effort underway to address some of these challenges.
However, there are areas where Europe needs a more practical and coordinated framework if it wants to remain competitive over the long term. I do think the pricing system needs to be revisited, and I also believe we need a stronger sense of a genuine single market rather than continuing to operate through fragmented national systems and regulatory structures. Measures such as stockpiling requirements are a good example of policies that may be well intentioned but can ultimately create inefficiencies, environmental waste, and supply distortions without necessarily benefiting patients. A similar concern applies to some of the current discussions around the Urban Wastewater Treatment Directive and extended producer responsibility mechanisms. We fully accept that we have a responsibility to contribute and support environmental objectives, but decisions of this scale need to be grounded in realistic assumptions, robust data, and a clear understanding of the operational consequences for the sector. The projected costs being discussed are already significantly higher than initially anticipated, which naturally creates uncertainty for operators across the industry. The question is not whether we should contribute. We should. The question is whether the framework being developed is proportionate, sustainable, and properly aligned with the realities of pharmaceutical manufacturing and supply.
More broadly, I think one of the biggest challenges for Europe is the level of regulatory volatility and uncertainty businesses are being asked to navigate. Over recent years, we have had to adapt to evolving sustainability reporting frameworks such as the Corporate Sustainability Reporting Directive (CSRD) and the Corporate Sustainability Due Diligence Directive (CSDDD), where requirements are introduced, revised, delayed, and then revisited again over extended periods of time. Companies can manage day-to-day volatility, but it becomes much harder when significant resources are committed to frameworks that continue shifting over several years. For me, Europe needs to stay focused on fundamentals. Our role is ultimately to deliver medicines reliably to patients, and we need an environment that supports long-term investment, competitiveness, and healthcare resilience while avoiding future risks around affordability, accessibility, and availability of medicines.
What business model has allowed Zentiva to remain competitive and continue growing within Europe’s generics market?
I think it starts with the strength of the European healthcare model itself. Europe has built healthcare systems around the principle that health is a right rather than a privilege, and that creates a very strong long-term foundation for our sector. There is still a tendency to view generics as something operating quietly in the background, when in reality we supply roughly 70 percent of the medicines dispensed across Europe today. That makes us fundamental to the functioning of healthcare systems and, in many ways, the backbone of European healthcare. I have enormous respect for the innovative sector and the scientific advances it continues to deliver, but affordable off-patent medicines remain absolutely essential to maintaining sustainable healthcare systems across the continent, and that role sometimes does not receive the recognition it deserves.
From a strategic perspective, we have focused on building a balanced and resilient portfolio rather than relying too heavily on any single area. We continue to have a strong position in traditional generics, dispensed as oral solid medicines, including tablets and antibiotics, while also expanding further into cardiovascular disease and biosimilars, where we continue to see growing penetration and long-term opportunity. We are also very interested in emerging therapeutic areas such as obesity and metabolic health. Zentiva was the first company to launch a generic version of Liraglutide in several European markets, including the UK, through our partnership with Biocon. It is an area where we are already seeing encouraging uptake and where the broader health benefits for patients and healthcare systems could become very significant over time.
Another important part of our model is that we remain focused on Europe. We do license some developments into markets such as the Middle East or Africa through B2B partnerships because we want patients to have broader access to medicines, but commercially we remain a Europe-focused business. That gives us a very clear identity and long-term strategic direction. At the same time, being a generics player means operating within highly regulated systems and depending heavily on the broader economic and policy environment. We continue to provide substantial savings to healthcare systems while also investing, innovating, and expanding into new areas, but long-term sustainability ultimately depends on creating an environment that allows companies like us to continue investing with confidence while maintaining resilience and competitiveness across Europe.
How does Zentiva approach the growing biosimilars opportunity within Europe?
We are very positive about biosimilars because the long-term market dynamics are clearly attractive. You can already see which biologics are coming off patent, you can see the increasing penetration across Europe, and you can also see the growing need for more affordable biologic medicines within healthcare systems. At the same time, our strategy is somewhat different from other players that are building fully integrated manufacturing platforms. That is not the route we are taking. Instead, we see a strong opportunity in combining Zentiva’s commercial infrastructure and European reach with external development and manufacturing expertise through partnerships, co-development models, and CDMO (Contract development and manufacturing) collaborations. We have already started building a presence in biosimilars across several therapeutic areas, including cardiovascular disease, and the experience has been very positive so far. More recently, we launched our first EU-wide monoclonal antibody biosimilar following EMA approval, specifically a denosumab biosimilar for bone-related conditions, which will now be rolled out progressively across European markets.
Our strength in this space comes from the scale of our commercial platform across Europe and the ability to combine that reach with partners that specialise in development and manufacturing. We are present across virtually every European market, and we believe that creates a very strong model when paired with the right external expertise. I also think Europe has started moving in a more pragmatic direction from a regulatory standpoint in certain areas of biosimilar development. In some cases, if the Phase II data are sufficiently robust, companies may no longer need to repeat extensive Phase III programmes, which can significantly reduce development costs and accelerate patient access while maintaining strong scientific standards. That is a positive development because it lowers barriers, improves efficiency, and ultimately benefits both healthcare systems and patients.
How does targeted M&A fit into Zentiva’s long-term strategy, and what made Apontis Pharma an attractive acquisition?
We already have a very strong organic pipeline across Europe and a well-established capability around launching and scaling products, which remains one of the core strengths of Zentiva as a business. Germany is naturally a very important market for us given its scale and significance within the European pharmaceutical landscape, but we also continue to hold strong positions across Central and Eastern Europe, and that broader European footprint remains central to our strategy. M&A therefore continues to play an important role in how we think about long-term growth, although we approach it in a very targeted and selective way. The objective is not simply to add scale, but to strengthen capabilities, therapeutic areas, and commercial models that genuinely complement what we already do well and help us bring medicines to patients more effectively across Europe.
That was very much the thinking behind the acquisition of Apontis Pharma. What attracted us was the strength of its single-pill combination platform, particularly in cardiovascular care, where several established medicines are combined into one treatment to simplify therapy and improve adherence for patients. The concept itself is relatively simple, but the execution, quality standards, and clinical positioning behind it are extremely important. We had known the business for some time through previous partnerships and had been very impressed by the way Apontis developed and commercialised the model. Beyond the obvious patient benefits, there are also clear advantages for healthcare systems through improved compliance and potentially better long-term outcomes. Strategically, the acquisition also strengthened our position in Germany by adding a more prescriber-focused commercial element alongside Zentiva’s traditionally strong tender and access business, creating broader opportunities for future portfolio expansion within the market.
Despite ongoing economic and regulatory uncertainty, where do you continue to see opportunity for growth in Europe?
I remain positive about Europe and about the long-term outlook for Zentiva, even within a slower-growth and sometimes volatile economic environment. Our ambition continues to be serving more patients and serving patients better, and that remains the driving force behind how we invest across the region, from strengthening local organisations and manufacturing capabilities to modernising our facilities and sustainability infrastructure. The long-term fundamentals in Europe remain strong. Populations are ageing, demand for medicines continues to increase, and healthcare systems will continue to require affordable and reliable access to treatment. Europe does, however, need to become easier and more efficient to operate within, whether through digital leaflets, freer movement of products across borders, a modern pricing system or reducing unnecessary complexity between the 27 individual member states. If those structural improvements can be combined with the strong healthcare fundamentals already in place, then Europe will remain a very attractive environment for long-term pharmaceutical investment and growth. For us as Zentiva, our commitment remains firmly centred on Europe.
How would you describe Zentiva’s culture and identity as a European pharmaceutical company?
Zentiva has a very strong heritage that dates back to 1488 and the historic Black Eagle pharmacy in Prague, which still exists today and remains an important part of our identity, particularly in the Czech Republic where Zentiva is viewed as part of the country’s healthcare and industrial legacy. At the same time, we are very much a European company, with major operations across the continent serving more than 100 million patients through a team of 5,400 people. Roughly half of our organisation works in manufacturing and development, which reflects both the scale of our industrial footprint and the role we play within European healthcare systems. We are a very operationally focused organisation, deeply committed to making sure medicines reach patients reliably, sustainably, and at scale across Europe. While Zentiva may not always be the most visible name internationally, it is a very solid and well-established business with deep roots across European markets.
In many ways, the culture of Zentiva is reflected in something very simple. I am originally from a very small village in Denmark, and one day my father went to the local pharmacy to collect his medicines. Out of the different boxes he received, one happened to be a Zentiva product. He was not specifically looking for Zentiva, but for me that moment captured exactly what we are about. We do not need to be the loudest pharmaceutical company in the market as long as patients receive the medicines they need. That is really the philosophy that drives us. We say in our purpose that we bring health and wellbeing for all generations, and I think that genuinely reflects both why and how we operate. We are proud of our heritage, proud of the role we play within European healthcare, and committed to continuing to invest, grow, and serve patients across the region for the long term.
What would be your key message to European policymakers and industry stakeholders?
If I had one message for European policymakers, it would be that Europe already has a very unique pharmaceutical ecosystem, and that should not be taken for granted. Across generics, innovative medicines, and consumer healthcare, Europe still combines scientific expertise, industrial capability, clinical research, and manufacturing strength that very few regions can replicate. At the same time, competition from the US, India and China is intensifying, so the priority now should be creating a modern, predictable framework that continues to support competitiveness, investment, sustainability, and healthcare resilience over the long term. Pharma remains one of the industries that genuinely makes a difference to people every single day, and Europe has a real opportunity to continue building on that strength if the right conditions are in place.
