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 help maintain high-quality healthcare systems over time? Biosimilars are an important part of the answer.
What are biosimilars?
A biosimilar is developed to be 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.
Due to the complexity of biological medicines, biosimilars are developed through a rigorous process to match the reference medicine as closely as 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 may lead to lower cost treatment options in some settings. This is where biosimilars may provide value for healthcare systems.
Lower costs may support more efficient use of healthcare resources and help create room for investment in new and innovative therapies. In this way, biosimilars support a healthcare system that remains sustainable over time.
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 biosimilars may contribute to broader availability of biological therapies within healthcare systems.
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 the long-term sustainability of healthcare systems, 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 cost considerations into better balance, supporting the long-term sustainability of healthcare systems.
Read more about biosimilars at Amgen:
