Healthcare systems across Europe, including the Netherlands, are facing increasing pressure. People are living longer, chronic conditions are becoming more common, and innovative biological treatments are expanding therapeutic possibilities. At the same time, healthcare costs continue to rise. The question is both urgent and essential: how can we ensure that high-quality healthcare remains accessible and affordable for everyone? Biosimilars are an important part of the answer.
What are biosimilars?
Biosimilars are biological medicines that are highly similar to an already approved biological medicine, also known as the reference medicine. Biological medicines are produced using living cells and consist of complex proteins. This makes them fundamentally different from traditional chemically manufactured medicines.
A biosimilar is not an exact copy of the original product - because of the complexity of biological manufacturing, that is not possible. What matters is that extensive comparative studies show there are no clinically meaningful differences in quality, safety and efficacy.
Before a biosimilar can be approved in the European Union, it undergoes a rigorous assessment within the European regulatory framework, with the EMA (European Medicines Agency) playing a central role. A biosimilar can only be authorized when the evidence shows no clinically meaningful differences compared with the reference medicine. 1
Why are biosimilars important for healthcare systems?
When the exclusivity of the original medicine expires, biosimilars can enter the market. That can lead to lower costs. This is where the societal value lies.
Lower costs allow healthcare budgets to be used more efficiently. More patients can be treated within the same budget, and resources can be freed up for investment in new and innovative therapies.
In this way, biosimilars support a healthcare system that remains both accessible and financially sustainable.
What do biosimilars mean for patients?
For patients, trust in their treatment is essential. Biosimilars meet the same strict standards of quality, safety and efficacy as other biological medicines. They are extensively compared and assessed before approval and remain subject to continuous safety monitoring after entering the market.
In practice, this means patients can rely on treatments that meet established regulatory standards, while cost savings can help support broader access to biological therapies2.
Amgen’s role in biosimilars and biological innovation
Amgen has a long-standing history in the research, development and manufacturing of biological medicines. Building on this scientific expertise, the company also invests in biosimilars.
For Amgen, biosimilars do not replace innovation; they complement it. They help support access to high-standard care, while quality, reliable supply and patient safety remain central.
Biosimilars and the future of sustainable healthcare
Biosimilars are now an established part of modern healthcare. They combine scientific rigor with societal impact.
At a time when healthcare expenditure continues to rise, biosimilars help bring quality and affordability into better balance, helping to ensure that high-quality care remains available to the people who need it.
Read more about biosimilars at Amgen:
