What are the upcoming changes for biosimilar medicines in the European Union?
A biosimilar is a medicines similar to a reference biologic that has been authorized in Europe for more than 8 years and whose patent has fallen into the public domain. Because of their complexity and the variability inherent in their manufacture, biosimilars require extensive clinical studies to demonstrate their similarity in terms of quality, efficacy and safety to the reference drug.
In today’s pharmaceutical industry, biosimilar medicines represent a major advance for our healthcare system. These biological medicines guarantee rigorously demonstrated therapeutic equivalence with reference treatments in terms of efficacy and safety. Their Marketing Authorization (MA) is subject to stringent European regulations, steered by the EMA (European Medicines Agency) through a centralized procedure, guaranteeing harmonized assessment of biosimilars.
A two-tier regulatory framework exists at European Union level:
- Centralized European marketing authorization
- National management of interchangeability and substitution issues
However, the interchangeability of biosimilars has not yet been fully harmonized at European level. Each member state retains the freedom to set its own criteria, although the EMA encourages a coordinated approach.
This regulatory framework makes it possible to combine scientific excellence and economic efficiency, while respecting the prerogatives of each member state and its public health policy. This organization is perfectly suited to the specific characteristics of biological substances and the challenges of making them accessible.
In addition, pharmaceutical companies are required to set up systems capable of detecting any undesirable effects and responding to requests for information from competent authorities such as the ANSM, thereby reinforcing patient protection.
Context and challenges of biosimilar medicines in Europe
To better understand the importance of biosimilar medicines, we need to examine their strategic position, their concrete benefits and the specific regulatory framework governing their development and marketing in Europe.
The role of biosimilar medicines in the European healthcare ecosystem
Biosimilar medicines play a key structural role in Europe’s healthcare system. They act as catalysts for change, striking a balance between innovation and accessibility to medical treatment. Their development requires in-depth expertise, particularly in clinical trials and the production of biological substances. Since the first biosimilar medicine was approved by the EMA in 2006, the European Union has confirmed its leading position, having approved the largest number of biosimilar medicines in the world.
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Advantages of biosimilars: accessibility, lower costs, therapeutic alternatives
Biosimilar medicines represent a major step forward in terms of access to care and cost control. They offer several advantages:
- Secure supply to limit shortages.
- Substantial savings for the healthcare system thanks to prices that are on average 30% lower than reference biologics.
- Savings from biosimilars enable investment in the development of new molecules and medical technologies.
Specific regulatory constraints compared to reference biologics
The authorization process for biosimilars differs from that for conventional generics and highlights the complexity of biological substances. The aim of biosimilar medicines development is to demonstrate biosimilarity, i.e. a high degree of similarity in terms of structure, biological activity, efficacy, safety and immunogenicity. The marketing authorization application must provide additional preclinical and clinical data to prove therapeutic equivalence, despite the natural variability of the biological active substance.
Upcomings changes for biosimilars medicines
In February 2024, the EMA proposed a concept paper whose aim would be to relax certain assessment criteria for biosimilars by considering relaxing the requirements for comparative efficacy studies for certain medicines with a well-established mechanism of action and for which sufficient comparability can be demonstrated by analytical and functional tests. This initiative, still under discussion, would aim to speed up approval, while guaranteeing efficacy and patient safety.
These forthcoming changes could have an impact on the entire pharmaceutical industry in Europe. For pharmaceutical companies, these changes could mean a significant adaptation of their development and financing strategies.
In addition, a review of European pharmaceutical legislation is scheduled for the coming years, with one of the objectives being to improve access to innovative, generic and biosimilar medicines in Europe.
The changes envisaged for biosimilar medicines illustrate the European Union’s determination to modernize its regulatory framework, while guaranteeing safety and accessibility. These changes pave the way for a more effective framework for the integration of biosimilars in Europe, guaranteeing both faster marketing and greater harmonization of practices between member states.
Europe thus confirms its commitment to an environment conducive to the development of high-quality biosimilar medicines, to the benefit of patients, healthcare systems and therapeutic innovation alike.
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