Nanomedicines and Nanosimilars: Building a robust legislative framework

26 July 2021

The EU has the chance to lead the world in developing a centralised regulatory procedure for nanomedicines and nanosimilars, argues Petar Vitanov

It is now time to scale up concrete actions to build a robust, legislative framework for nanomedicines and nanosimilars for the benefits of all European patients.

Nanotechnology is an emerging innovative technology with the potential to address unmet medical needs and offers alternatives for several therapeutic areas.

Nanomedicines offer potential solutions for a number of current treatment challenges, including cancer, cardiovascular and neurodegenerative disorders, as well as other diseases. It is also important to note that the innovative mRNA vaccines contain nanoparticles.

Nanomedicines and their follow-on products, also referred to as nanosimilars, are complex molecules and so regulatory oversight must be scientifically fit for purpose.

They are proving to be very important in oncology treatments and have reduced mortality in cancer patients and also have had a positive impact in therapies that target specific cells.

The European Alliance for Access to Safe Medicines along with several patient safety member organisations of the Nanomedicines Regulatory Coalition are calling on the European Commission to accelerate actions in the field of nanomedicines.

The hope is to address unmet medical needs so that regulatory weaknesses can be addressed through a robust regulatory pathway and thus provide medicines with the highest quality, safety and efficacy profiles for European patients.

Nanomedicines offer potential solutions for a number of current treatment challenges, including cancer, cardiovascular and neurodegenerative disorders, as well as other diseases. It is also important to note that the innovative mRNA vaccines contain nanoparticles

This not only applies to existing medicines but the plethora of new medicines that are in the pipeline. Nanomedicines are Innovative and enhance the way that medicines target and reach areas of disease within the body, as well as having inherent therapeutic activity, making treatments highly effective.

They are also complex, consisting of multifaceted nanoparticles engineered to have favourable biological, chemical, pharmacological as well as immunological properties.

Assembling different chemical parts into complex nanoparticles requires highly standardised and complex manufacturing processes that can guarantee consistent quality, clinical effectiveness and safety.

Changes in quality, size distribution, surface properties, drug loading and release profiles, aggregation status and stability can alter how a nanomedicine acts within the body with a significant impact on patient safety and efficacy.

This was highlighted in a recent EAASM scientific report which makes key recommendations to ensure patient safety and enable the EU to fully harness the potential of nanotechnology.

The report calls for the development of a scientific consensus on definitions for nanomedicines in Europe, improving education and fostering awareness on the complexity and sophistication of nanomedicines among policy makers, prescribers, payers and patients.

It also advocates adopting a European Medicines Agency (EMA) centralised procedure for all nanomedicines and nanosimilars which would ensure greater scrutiny of these complex products.

It is critical that we as policymakers, together with patient representatives, healthcare professionals, and the pharmaceutical sector, contribute to the creation of a resilient and sustainable healthcare landscape that ensures innovative medicines for all citizens in the EU

This is key to avoiding diverging approaches between Member States and ensure long-term safety and risk management.

Finally, the report recommends clarifying the regulatory criteria for the approval of follow-on/nanosimilar medicines. As manufacturing exact replicas of nanomedicines is not achievable, therapeutic similarity will need to be shown through clinical evidence. In addition, the highest possible manufacturing standards must be guaranteed and included in the licence application.

The revision of the basic pharmaceutical legislation paves the way for a future proof and crisis resistant regulatory landscape, through delegated acts or through a principles-based approach where regulators and agencies will assess products in a more flexible, dynamic way.

Also, one of the main goals to be achieved within the Strategy of the EMA network to 2025 is to enable and leverage research and innovation in regulatory science. Hence, such innovations may facilitate the implementation of novel manufacturing technologies and delivery approaches, including nanotechnology.

The ongoing COVID pandemic has demonstrated that a strong, innovative European pharmaceutical sector is crucial. Similarly, it is critical that we as policymakers, together with patient representatives, healthcare professionals, and the pharmaceutical sector, contribute to the creation of a resilient and sustainable healthcare landscape that ensures innovative medicines for all citizens in the EU.

As an MEP actively involved in health care, and with the progress of the Pharmaceutical Strategy for Europe, it is the right time to set the scene for building a pan-European medical agency consensus so that regulatory weaknesses can be addressed through a robust regulatory pathway and thus provide medicines with the highest quality, safety and efficacy profiles for European patients.

I invite you to get in contact with the Nanomedicines Regulatory Coalition secretariat and visit the new NRC website to endorse more collaborative actions for a new and robust regulatory framework for nanomedicines and nanosimilars in Europe.

Petar VITANOV

Bulgaria
Group of the Progressive Alliance of Socialists and Democrats in the European Parliament