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PRESS RELEASE: Nanomedicines and nanosimilars: the medical need for a centralised EMA regulatory process

Nanomedicines enhance the way that medicines target and reach areas of disease within the body, opening up new therapeutic options. They offer potential solutions for current treatment challenges, such as cancer, cardiovascular and neurodegenerative diseases, as well as other illnesses.

Moreover, follow-on nanomedicines / nanosimilars are receiving more and more attention since patents of reference originator products are expiring. However, their complexity creates challenges in demonstrating the accurate comparability and equivalence of the follow-on product. Key to this is the fact that nanomedicines are highly dependent on a robust well-controlled manufacturing process. Changes in, size distribution, surface properties, drug loading and release profile, aggregation status and stability – can alter how a nanomedicine acts within the body which can have an impact on the efficacy and safety profile of the product123. This provides challenges for follow-on manufacturers to replicate these products once market exclusivity of the originator has expired. The EAASM is proud to announce that its amendments have been included in the European Parliament’s INI pharma report. With this institutional support, it will add weight to the call for a centralised regulatory process for nanomedicines and nanosimilars. As there is currently a lack of a fit for purpose regulatory framework specific for nanomedicines and nanosimilars, and there is concern this could have implications for patient safety. In order to fully harness the potential of nanomedicines and to protect patient safety, a dedicated regulatory framework for this class of products is needed at EU level.

The recently held webinar titled “Nanomedicines and nanosimilars: the medical need for a centralised EMA regulatory process” was co-hosted by the non-profit patient safety organisation, the EAASM and MEP Petar Vitanov (S&D, Bulgaria). It brought together experts operating in several sectors, including patient safety organisations, the EU Commission, industries, healthcare professionals and academics to debate the challenges and potential practical solutions for nanomedicines at the EU level.

The webinar aimed to lay out the medical need for a centralised regulatory framework specific to nanomedicines and nanosimilars. The evidence and rationale for this came from MEP Petar Vitanov, Mr. Mike Isles (EAASM Executive Director), Prof. Dr. Scott McNeil (University of Basel), Jon de Vlieger PhD (Lygature, the Netherlands) and Dr. Josep M Guiu (International Pharmaceutical Federation) and Dr. Andrzej Rys (DG SANTE, European Commission).

The scientific proposition for an EMA centralised regulatory procedure can be summarised as follows:

  1. Nanomedicines and nanosimilars are highly complex products that rely on a robust and well controlled manufacturing process – as such follow-on nanomedicines can only ever be similar and require clinical evidence to ensure an adequate level of similarity from a safety and efficacy standpoint. A group of experts in fact, concluded “This very complex molecular and/or product structure makes it practically impossible to develop generic alternatives, i.e. products with an identical molecular composition…and so…a simple authorization referencing another product, solely supported by evidence of pharmacokinetic bioequivalence based on a single ingredient, is definitely not acceptable”. In addition “…interchangeability of such medicines requires clear clinical oversight based on evidence and so “…substitution can therefore – analogous to biosimilars – not be recommended until confirmation of “therapeutic interchangeability” is available”4
  2. Currently the regulatory assessment is heterogenous, demonstrated by 85 follow-on products approved in 2018 were approved by different regulatory pathways (from the generic, to biosimilars, hybrid as well as centralised and decentralised procedures). Not only does this give rise to different criteria being used for assessment, it means that multiple brand names proliferate thus making adverse event pharmacovigilance linkage difficult.5

If you would like further information, please do not hesitate to contact Mr. Mike Isles (mike.isles@eaasm.eu) or Ms. Laura Cigolot (laura.cigolot@eaasm.eu).

ABOUT THE EAASM

The European Alliance for Access to Safe Medicines (EAASM) is an independent, non-profit pan-European Community Interest Company dedicated to protecting patient safety. The Alliance champions many patient safety issues to enhance medical practices. It especially believes that the rapidly developing field of nanomedicines requires regulatory clarity to ensure patient safety and to realise new treatment opportunities across Europe in a harmonised way.
To find out more about the EAASM, please visit the website https://eaasm.eu/en-gb/ and follow @EAASMeds on Twitter.


1 Jing Zhang et al. Int J Nanomedicine. 2017; 10.2147/ IJN.S148359
2 Rottembourg J, Kadri A, Leonard E, Dansaert A, Lafuma A. Do two intravenous iron sucrose preparations have the same efficacy? Nephrol Dial Transplant. 2011; 26:3262–7
3 Mühlebach S, Borchard G, Yildiz S. Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars. Nanomedicine 2015 Mar;10(4):659
4 Statement on the “Interchangeability of drugs with a complex active substance composition” This statement was prepared on the basis of the results of a consultation of experts organized by the German Pharmaceutical Association [DPhG]) together with the House of Pharma & Healthcare, Frankfurt. https://www.houseofpharma.de/dialog/expertentreffen/nbcd/statement-nbcd-englisch/
5 K. Klein, P. Stolk, M. L. Dr Bruin, H. G. M. Leufkens, D. J. A. Crommelin, J. S. B. Dr Vlieger: The EU Regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations, EuropeanJournal of Pharmaceutical Sciences 133 (2019) 228-235