At Sandoz, scientists are driving the next generation of biosimilars for monoclonal antibodies and recombinant proteins—innovations that bring advanced, reliable treatments for cancer, autoimmune diseases, and growth disorders within reach of more patients worldwide.
These significant developments were highlighted in an exclusive interview with Theo Vasileiou, Country Head of Sandoz Romania, recently published by Surse și Resurse.
On this occasion, Vasileiou outlined the company’s growth strategy in the local market. This strategy is anchored in three fundamental pillars: portfolio diversification, stakeholder collaboration, and organizational resilience. These priorities drive efforts to strengthen Sandoz’s presence across key therapeutic areas, expand patient access to high-quality, cost-effective treatments, and work closely with healthcare authorities to help shape sustainable policies that ensure long-term access and healthcare system efficiency.
Ionel Văduva: Sandoz has been a pioneer in biosimilars, setting benchmarks for innovation and access. Could you elaborate on the current pipeline of biosimilar candidates under development? Are there specific therapeutic areas or unmet medical needs that you are prioritizing globally, and how do these align with trends in patient demand?
Theo Vasileiou, Country Head Sandoz Romania: Biosimilars are a key strategic pillar for Sandoz globally, and we continue to invest significantly in expanding our pipeline. Currently, we have over 15 biosimilar molecules in various stages of development, encompassing high-impact therapeutic areas such as oncology, immunology, and endocrinology. These are fields where biologics have transformed care but where access remains a challenge due to high costs.
We focus on diseases with high prevalence and unmet medical needs, aiming to democratize access to these life-changing therapies. For example, we are developing biosimilars for monoclonal antibodies and recombinant proteins that treat conditions such as cancer, autoimmune diseases, and growth disorders. These align closely with global trends, where patient demand for biologic therapies is increasing, but cost remains a major barrier, particularly in emerging markets.
Our innovation is not only in development but also in how we bring these products to market efficiently, ensuring high standards of quality, safety, and supply reliability. This integrated approach allows us to fulfill our mission: pioneering access for patients.
I.V.: Emerging markets like Romania represent both challenges and opportunities for the pharmaceutical industry. How does Sandoz approach strategic growth in these markets while balancing the need for affordable healthcare solutions and the pressures of a competitive global market?
Theo Vasileiou: Emerging markets are at the heart of our mission at Sandoz. They embody the tension between rising healthcare demand and limited resources, exactly where generics and biosimilars can make the biggest difference.
In Romania, our growth strategy is focused on three main pillars: portfolio diversification, stakeholder collaboration, and organizational resilience. We are expanding our footprint across key therapeutic areas, ensuring that patients have access to a broader range of high-quality, affordable treatments. At the same time, we engage actively with healthcare authorities to shape policies that enable long-term access and cost-efficiency.
From a global standpoint, we also leverage Sandoz’s scale and expertise to deliver consistent quality and supply, even in highly regulated or price-sensitive markets. Balancing affordability with innovation is not just a challenge—it’s an opportunity to prove that sustainable access is achievable, even under economic pressure.
I.V.: The adoption of biosimilars often hinges on collaboration between pharmaceutical companies, healthcare providers, and policymakers. What are some key initiatives or partnerships Sandoz is pursuing in Romania to drive biosimilar adoption and improve patient outcomes? How do you address misconceptions about biosimilar efficacy or safety in these efforts?
Theo Vasileiou: Indeed, biosimilar adoption requires a coordinated effort across the healthcare ecosystem. At Sandoz, we’ve consistently worked to build strong partnerships with medical professionals, academic institutions, and policymakers to support informed decision-making and patient access.
One particularly positive step was the adoption in 2023 of legislation requiring that at least 50% of prescriptions within a molecule be for biosimilars. This is a clear and encouraging signal that Romanian health authorities recognize the value of biosimilars—not only in terms of cost-efficiency but also in expanding patient access to biologic therapies. We fully support this direction and see it as an important foundation for future progress.
At Sandoz, we complement such policy efforts with robust medical education programs, scientific exchange, and real-world data dissemination. We also invest in training initiatives for healthcare professionals to ensure they are confident in the efficacy, safety, and quality of biosimilars.
To address misconceptions, we focus on transparent communication supported by rigorous clinical evidence and long-term pharmacovigilance. Our goal is to help normalize biosimilars as trusted, first-line therapeutic options—ultimately contributing to better outcomes for patients and a more resilient healthcare system.
I.V.: Romania faces significant challenges in ensuring equitable access to medicines, including the impact of the clawback tax on pharmaceutical companies. How do you see this policy affecting the availability and affordability of biosimilars and generics? What reforms would you advocate for to create a more sustainable market environment?
Theo Vasileiou: The clawback tax, while originally intended as a temporary measure, has unfortunately become a structural burden that disproportionately affects lower-cost medicines such as generics and biosimilars. Its current form puts unsustainable pressure on the very products designed to reduce healthcare costs and expand access.
This has two key consequences: first, it limits the availability of affordable treatments, especially for vulnerable patient groups; second, it discourages investment and innovation in the Romanian market. As a statistic, Romania has five times fewer generics medicines available on the market than Germany and two times fewer than Poland or the Czech Republic.
For biosimilars in particular, the delay in reimbursement and limited incentives for adoption slow down the entire process of improving access.
We believe targeted reforms are essential.
These include: adjusting the clawback calculation for generics and biosimilars from 15% currently to 10% in a first stage; speeding up reimbursement for biosimilars when reference products are already funded (cost-volume agreements); creating a more predictable pricing and regulatory framework, as the current philosophy of the European minimum price proved its deficiencies in the past 15 years.
If implemented, these changes could significantly enhance patient access while supporting the long-term sustainability of the healthcare system, allowing authorities to invest in innovative therapies.
I.V.: As Europe continues to emphasize innovation and healthcare sustainability, where do you see biosimilars fitting into the broader strategy for healthcare systems? What role does Sandoz aim to play in shaping future EU-level policies, and how can Romania’s experience serve as a case study for improving biosimilar accessibility and adoption?
Theo Vasileiou: Biosimilars are an indispensable part of Europe’s strategy for sustainable healthcare. They offer an immediate and scalable solution to rising costs in chronic and life-threatening diseases, conditions that place enormous strain on national health budgets.
Sandoz has long been a trusted partner for European health systems, and we aim to continue playing a leading role in shaping biosimilar policy. This includes contributing to EU-level discussions on regulatory harmonization, incentives for biosimilar uptake, and best practices for market entry and procurement.
Romania’s experience is a valuable case study because it reflects both the challenges and potential of biosimilar adoption. Despite fiscal and policy constraints, there is growing recognition of the value biosimilars bring. With the right policy reforms—such as faster reimbursement, educational efforts, and sustainable pricing—we believe Romania can evolve into a model for biosimilar access in Central and Eastern Europe.
Ultimately, our goal is to help build a healthcare system where innovation and affordability are not mutually exclusive—and where every patient, regardless of geography or income, has access to high-quality treatment options.
