Earlier this year, the European Commission proposed a major revision of the pharmaceutical legislation governing the bloc. The reform aims to ensure timely and equitable access to safe, effective, and affordable medicines for all EU patients, enhance supply security, and maintain an innovation-friendly environment for research and production.
At the heart of this legislative push lies a concept that remains poorly understood outside specialist circles: medical interchangeability. This principle is particularly relevant for biosimilars—medications that are highly similar, though not molecularly identical, to their reference biologic drugs. Biosimilars offer the same therapeutic outcomes as the originator products but at a significantly lower cost.
What Does Interchangeability Mean in Practice?
To clarify the term, European Pulse spoke with Steffen Thristrup, Chief Medical Officer at the European Medicines Agency (EMA) in Amsterdam. “Interchangeability means that you can substitute or switch one product with another,” Thristrup explained.
In the context of biosimilars, interchangeability refers to the ability to switch a patient who has already been treated with the reference biologic to a biosimilar version—or even between different biosimilars of the same reference product. “Ultimately, patients could begin treatment on a biosimilar instead, so that they don’t have to go via the originator product,” Thristrup added.
The key advantage is financial. “There is no therapeutic advantage because these products are the same. They have the same efficacy and the same safety as the reference medicine. But there is an opportunity, because they are typically available at a lower price, so the healthcare system can save money, or they can maybe even offer the same treatment to more patients at the same cost,” he said.
This cost-saving potential is critical for Europe’s overstretched health systems, which are grappling with rising demand and budget constraints. The ILO report on work-related stress highlights how health systems are already under pressure, and biosimilar interchangeability could free up resources for other priorities.
However, the concept is not without controversy. Some clinicians and patient groups worry about the implications of switching patients without their explicit consent, particularly for chronic conditions where treatment stability is paramount. The EMA’s position is that interchangeability decisions should be based on robust scientific evidence and made at the national level, respecting each member state’s regulatory framework.
Thristrup emphasized that the EMA’s role is to provide scientific guidance, not to mandate switching. “We assess the quality, safety, and efficacy of biosimilars. The decision on interchangeability is a national competence, often involving health technology assessment bodies and clinical guidelines,” he said.
The European Commission’s pharmaceutical reform also aims to harmonize these processes across the EU, reducing fragmentation that currently hinders biosimilar uptake. Countries like Germany and France have already adopted policies encouraging biosimilar use, while others lag behind due to regulatory or market barriers.
Beyond cost savings, interchangeability could improve patient access to biologic therapies, which are often expensive and used for conditions like rheumatoid arthritis, cancer, and diabetes. By enabling substitution at the pharmacy level, health systems can expand coverage without increasing expenditure.
The broader context includes ongoing debates about drug pricing and sustainability. As the synthetic drugs reshape global markets, health systems face additional strain, making biosimilar interchangeability a timely tool for efficiency.
For now, the EMA continues to evaluate biosimilars on a case-by-case basis, ensuring that any product deemed interchangeable meets the same high standards as the original. Thristrup concluded: “Our goal is to provide patients and healthcare professionals with confidence that these products are safe and effective. The savings can then be reinvested into better care.”
