Biosimilar medicines contain the same active substance and have the same therapeutic effect as branded medicines. Depending on the case, their price is at least 32% to at least 38% lower than the original price of the branded medicine. Biosimilars are essential to making expensive biologic treatments available as widely as possible.
To date, we have experience from 700 million patient days with biosimilars registered in Europe. Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines.
Biosimilars are characterised by their complex production process. In contrast to the creation of a simple chemical compound medicine, biological medicines – including biosimilars – are derived from living organisms. This relies on extensive investment by the companies that are bringing them on the market. The commercialisation of a biosimilar in a specific market must therefore be thoroughly assessed in terms of feasibility and success.
And that is exactly the problem in Belgium. Sometimes, many years after the biosimilar has become available, its market volume remains too low. This is manifestly insufficient for an acceptable 'return on investment'. Figures from other European countries show that Belgium is lagging far behind in the use of biosimilars. This inhibits market competition and may, consequently, pose a threat to the availability of these medicines for Belgian patients.
A healthy climate for biosimilars in Belgium is of essential importance, because their mere availability results in added value, since biosimilars immediately lower the federal healthcare expenditure. Hence, they create budgetary space for treating new patient groups or make resources available for expensive innovative medicines. The potential to tap is huge: today, the total federal budget for biological medicines for which a biosimilar is already available on the Belgian market or is expected to be available over the coming years amounts to more than half a billion euros. This potential can be realised not only by administering biosimilars to new patients but also by ‘switching’ existing patients to biosimilar medicines.
From an international perspective, scientific discussions on the application of switch programmes are now far behind us. For this reason, the medicines agency FAMHP has given the green light to switching in 2016.
Medaxes is therefore focusing on initiatives accelerating the uptake of biosimilars in Belgium. These medicines are just as high-quality, safe and effective as the original, and are perfectly interchangeable. Belgium should not miss the opportunity for its healthcare insurance.