More affordable healthcare
Demand for biological medicines appears at a time when healthcare systems are under pressure to generate savings and efficiencies. But due to the complex way biological medicines are developed and produced, they count among the most expensive medicines available on the market. The idea behind biosimilars is to give more people access to affordable healthcare.
Biosimilars are approximately 20 to 25% more cost-effective than the reference products.*
*Pro Generika e.V.
Why choose biosimilars?
Biosimilars offer a range of potential benefits for providers, patients and payers.
Improved access
More affordable than the reference biologics, which clinicians can be reluctant to prescribe.
More treatment options
An additional therapy for patients with serious and life-threatening diseases.
Highly effective
The same high standards of quality, safety, and efficacy as the biological medicine's corresponding reference product.
EU-approved
Assessed by the European Medicines Agency (EMA), and approved by the European Commission for use in EU patients.
Healthcare savings
Potential savings and efficiencies to relieve pressure on healthcare systems.
Our Mission - Your Health
The health of people is our priority at STADA. Through an easier access to safe and affordable treatments, the well-being of the patients can be significantly improved.
Competition cuts costs
Just like generic medicines, such as own-brand aspirins, biosimilars lead to more competition, which reduces the cost of the medicines. However, the price difference will not be as significant as the difference between a generic copy of a chemically produced drug and its reference product. This is due to the fact that biosimilars are made by using highly complex biotechnological processes and take considerably more time and effort to be developed and controlled in the production process. Furthermore, a significant amount of clinical data needs to be submitted before biosimilars can gain approval from European authorities.
Myths & Facts
Will the price be as low as for a generic copy?
Unfortunately not, due to higher development cost, a complex manufacturing process and extensive testing, the generic price reduction is not applicable.
How can they take the financial burden off the healthcare system if the price is only a little lower?
Considering the high price of biological medicines, even a relatively small discount could result in significant savings for the healthcare system.
Are biosimilars of less quality compared to the reference product?
No. Biosimilars undergo clinical studies, pharmacodynamic, and pharmacokinetic testing, which ensure that efficacy and safety are unchanged.
Are biosimilars comparable to the reference product?
Regulatory guidelines recommend a stepwise development process that involves demonstration of structural similarity and functional equivalence. This is called the totality of evidence, which highlights the high degree of similarity of biosimilar and reference product.
Is the reference product the gold standard?
There is no gold standard. Each biological medicine, even the reference product, varies from lot to lot. This variation lies within an acceptable range in which safety and function are not influenced. The range between the reference product and a biosimilar is tested not to be clinically meaningful.