Leadership in today's pharmaceutical industry is no longer defined solely by the strength of a pipeline, but by the ability to anticipate change, execute consistently and adapt at scale. As Europe rethinks the balance between affordability, resilience and innovation, Michal Nitka, SVP, Head Generics Europe & Global Head OTC at Teva, explains how the company is strengthening its leadership through disciplined execution, strategic partnerships and a diversified portfolio spanning generics, biosimilars and OTC medicines.
How would you describe your role today, and how does it reflect Teva’s broader strategic direction?
At Teva, we are organised across three geographic segments: the United States, Europe and International Markets. Within Europe, I am responsible for strategy of generics business franchise, which includes generics, biosimilars and over-the-counter (OTC) medicines, while globally I lead our OTC business, supported by central strategic capabilities primarily based in Europe.
This dual responsibility reflects how the OTC business has evolved over the past few years. Following the end of our PGT Healthcare joint venture with Procter & Gamble in 2018, we strengthened OTC through a dedicated operating model that works closely with our generics franchise. Today, we combine central strategic capabilities based in Europe with strong local market management. Local brands remain tailored to individual markets, while international brands such as Sudocrem are managed globally. Given the strength of our OTC business across Europe and the capabilities developed here, it made sense for the central OTC team to be based in Europe. I took on that responsibility around five years ago, drawing on my previous OTC experience.
While our structure has evolved, our purpose has remained the same. We are here to improve patients’ health by expanding access to affordable medicines while addressing unmet medical needs through innovative therapies. What has changed is the way we execute that mission. Since launching our Pivot to Growth strategy, we have become much more focused and disciplined in how we deliver against it. Generics remain the backbone of our business, providing broad access to affordable medicines, while we continue to strengthen our innovative portfolio. Innovation is no longer something we are building towards. It is already an integral part of Teva today.
What underpins Teva’s approach to the generics business in Europe, and where do you see the greatest drivers of growth?
Our generics strategy reflects the diversity of the European market. We operate across branded generics, retail and tender-driven markets, each of which requires deep understanding of market dynamics, a different commercial approach and launch strategy. While the execution differs from market to market, the objective is always the same: when a molecule goes off patent, we want to bring high-quality, affordable medicines to patients as quickly as possible, ideally as one of the first companies to launch.
That is important because generics and biosimilars remain a fundamental part of Europe’s healthcare systems. They account for around 70 percent of treatment volume while representing only around 20 percent of pharmaceutical spending, making it possible to expand patient access while supporting the sustainability of healthcare systems. That continues to be the foundation of our generics business. Alongside it, our innovative portfolio is more focused, concentrating primarily on neuroscience and immunology, where we are developing therapies for areas of significant unmet medical need.
I see two main drivers. The first is the size of Europe. Europe has well developed heath care system and an ageing population, which continues to increase demand for affordable therapies and creates a growing need for sustainable healthcare solutions. The second is execution, and that is where we believe we can make the difference. Success begins years before a product reaches the market, particularly for more complex medicines, with disciplined portfolio selection and careful decisions about whether to develop a product internally or through a partnership. From there, it is about completing development, securing approval and bringing the product to market at exactly the right time. The strategy itself is relatively straightforward. The real challenge, and where success is determined, lies in consistently executing every step of that process.
What does successful execution look like across Europe’s highly diverse generics markets?
Execution starts with having a very clear focus and segmentation. Europe is far from a homogeneous market, so our strategy has to reflect the different market archetypes we operate in, whether branded generics, retail or tender-driven markets. Each requires a different commercial and launch approach, but the principle remains the same. We continuously monitor patient needs and molecules coming off patent, then build the right pipeline and bring those products to market at the right time. Launch timing inevitably varies across countries, as healthcare systems, access pathways and market conditions differ from market to market. Still, where conditions allow, bringing a generic product to market early remains a key success factor — and at Teva, we continue to have the capabilities and experience to be part of that first wave. That has to be achieved in one of the world’s most competitive and fragmented markets. We compete with global companies, strong regional players and relevant local competitors, each bringing a different dynamic. At the same time, Europe is home to some of the world’s most developed healthcare systems. As science and diagnostics advance and treatments increasingly move towards earlier intervention to improve health outcomes, demand for effective and accessible therapies continue to grow, so the opportunity remains very much here. Growth is absolutely possible in Europe. We have a clear view of where we want to grow, and where we want to lead, and where will pursue opportunities more selectively. I cannot share the specifics of our strategy, but what differentiates us is the speed and clarity and discipline with which we execute. We have the dedication and capabilities to make decisions early, allocate resources accordingly and move quickly from strategy to implementation.
New launches remain essential because they create both additional volume and value, but the established portfolio is just as important, particularly as mature products naturally face price and volume erosion. Managing that balance is critical, and the approach again depends on the market. In tender-driven markets, success depends on the right portfolio and procurement conditions that support sustainable participation, including multi-winner tenders, while in branded generic markets it comes down to maintaining strong positioning, effective promotion and the right share of voice.
How can Europe strike the right balance between affordability and supply resilience in medicines procurement?
We need to look at procurement from a much broader perspective than price alone. Medicines are a strategic asset for Europe’s healthcare security. In markets where tenders are driven primarily by the lowest price, sustained downward pressure can weaken the economics of supply, reduce the number of viable manufacturers and increase the risk of shortages. Price is not the only factor behind supply disruption, but the way procurement is designed can certainly contribute to it. Teva’s Critical Medicines Health Check report shows how serious this risk has become: 46 percent of critical generic medicines now have only one supplier, and 83 percent are heavily dependent on a single dominant supplier. At the same time, around 30 percent of critical generic medicines marketed in 2014 have been withdrawn from at least one market, while 9 percent have disappeared entirely. This creates a vicious cycle: lower prices lead to fewer suppliers, fewer suppliers increase supply risk, and higher supply risk ultimately threatens patient access.
That is why the Critical Medicines Act is particularly important. It acknowledges that security of medicine supply is a strategic issue for Europe, not only a question of cost. We are encouraged that the Act includes procurement approaches that recognise supply security, diversification and resilience. We also welcome efforts to avoid disproportionate stockpiling requirements, which could unintentionally distort markets and create additional pressure on supply. The success of the Critical Medicines Act will ultimately depend on how Member States translate its objectives into national procurement practices. If governments continue to run a race to the lowest price, and do not reform their public procurement frameworks by integrating the provision of this legislation, the impact of the Act will be limited. The General Pharmaceutical Legislation also brings important progress by enabling day-one readiness for generic and biosimilar launches through a strengthened Bolar exemption. In parallel, the Biotech Act sends another positive signal. Europe needs a strong biotechnology ecosystem, and both innovative medicines and biosimilars have an important role to play in achieving that ambition. The direction is encouraging. The challenge now is implementation.
At the same time, Europe needs greater policy coherence across its legislative agenda. We fully support environmental objectives, but measures such as the Urban Wastewater Treatment Directive and its Extended Producer Responsibility framework must avoid placing a disproportionate burden on generic and critical medicines, which could undermine supply resilience. The same principle should guide PFAS discussions, where decisions must be based on robust science and their impact on medicine availability, patient care and Europe’s manufacturing base. Europe cannot successfully strengthen supply resilience through the Critical Medicines Act while simultaneously introducing policies that undermine the economic viability of critical and generic medicines. The environmental legislation like the UWWTD or PFAS and industrial policy like the CMA should work towards the same objective: ensuring a sustainable, resilient and competitive supply of medicines for European patients. What gives me confidence is not only the legislation itself, but the broader change in mindset. The direction is clearly the right one. The next challenge is implementation, because while European legislation can provide the framework, its success will ultimately depend on how it is put into practice across individual countries.
If there is one message, I would leave policymakers with, it is to view generics as a strategic partner in Europe’s healthcare systems rather than simply as a mechanism for reducing costs. If Europe can align these priorities, it has a real opportunity to build a medicines ecosystem that is more resilient, more competitive and ultimately better for patients.
How does Europe fit within Teva’s long-term strategy, and what role are generics, OTC and biosimilars playing in that evolution?
Europe is strategically important for Teva from both a generics and an innovation perspective. Across Europe, our off-patent portfolio spans three complementary areas, generics, biosimilars and OTC medicines, allowing us to support patients across the full continuum of care. Each part of our portfolio plays a distinct role in supporting patients and healthcare systems. OTC medicines contribute to that balance by enabling appropriate self-care where suitable, with pharmacists playing an important role in guiding patients and helping reduce unnecessary pressure on physicians. Generics build on that by expanding access once medicines lose patent protection, allowing many more patients to benefit from well-established therapies, as we have seen across therapeutic areas such as cardiovascular disease and gastroenterology. Innovation then complements the portfolio by addressing areas where significant unmet medical needs remain.
Biosimilars represent one of the most significant growth opportunities in healthcare today. Our focus is on therapeutic areas where biologics have transformed patient outcomes, including oncology, immunology, ophthalmology and respiratory diseases. Looking ahead, a significant share of medicines losing exclusivity over the coming decade will be biologics, creating a major opportunity to expand patient access while supporting healthcare sustainability. Teva is well positioned to capture that opportunity, combining a strong commercial footprint and experience navigating diverse reimbursement and procurement environments across Europe. Our model rests on two pillars: an internal pipeline of products developed and manufactured within Teva, and external innovation through partnerships and in-licensing, which we expect to become an increasingly important contributor to the business. A recent example is our global licensing agreement with Polpharma Biologics.
We also pursue Europe-specific collaborations and local business development opportunities where market conditions and legislation create the right environment. At the same time, we are seeing biosimilar markets evolve, with some countries moving beyond the traditional hospital setting towards greater use of retail pharmacies, supported by pharmacy substitution and other national policies.
What kind of culture and organisational mindset are needed to turn strategy into consistent execution?
For me, it starts with culture. Teva has a very entrepreneurial mindset, and one of its defining characteristics is that there is no real status quo. We are constantly asking ourselves what we can do better, what we can do differently and how we can move faster to serve our stakeholders. We encourage people to make decisions rather than spend too much time deliberating, because if you want to be first to market, speed of execution matters. Strategy is important, but it only creates value if people are empowered to act on it.
We have an excellent team with the right balance of experience and new capabilities. We have strong local teams with a deep understanding of their markets, while continuing to bring in people who add the expertise we will need for the future. At the same time, we have modernised and standardised many parts of the organisation, making us more effective and enabling us to allocate resources where they can have the greatest impact. Ultimately, it comes down to having the right people, with the right capabilities, focused on the right priorities.
Over the past two or three years, the organization has changed fundamentally. We have established the foundation, our strategy is clear, and today the focus is firmly on execution. There is no shortage of good strategies in our industry, and you can always develop another plan. What differentiates one organisation from another is the ability to implement that strategy consistently and at pace. That, more than anything else, is where Teva has made the difference.
Looking ahead, what are your priorities for the next phase of Teva’s journey, and what continues to inspire you as a leader?
We have now completed the first three years of our Pivot to Growth journey, delivered against the initial milestones and entered the next phase of acceleration. The foundations are in place, and our focus is on continuing to strengthen the generics business with biosimilars and OTC while advancing innovation and the broader transformation of Teva. The environment will continue to evolve, so we need to stay agile and adapt where necessary, but the direction is clear and we remain confident in the strategy we have set.
That clarity extends across the business. In generics, it is about maintaining the focus, tailored to the realities of each market. In innovation, we continue to advance a focused research and development pipeline, while remaining equally clear about our ambitions for biosimilars and OTC portfolio, including the global brand Sudocrem. Partnerships and in-licensing will continue to play an important role in our growth, supported by strong relationships with partners whose development and manufacturing capabilities complement Teva’s strengths in regulatory, commercial and market access.
What continues to excite me most, however, is execution. Every strategy begins with assumptions and a view of where the market is heading, but what really matters is seeing those plans translated into reality. There is nothing more rewarding than watching a team deliver against that vision and, in many cases, achieve more than you originally thought possible. That, together with knowing that our work ultimately helps patients access the medicines they need and supports stronger, more sustainable healthcare systems, remains the most satisfying part of the job and the strongest motivation for what comes next
