1ISG-010 The cost of lacking regulatory clarity for nanosimilars

BackgroundToday up to 23 nanomedicines are approved, and approximately 50 are in clinical development. In the past, first follow-on products also referred to as nanosimilars have entered the European market through the generic approval pathway. Significant differences have been observed in clinical practice raising doubt about their therapeutic equivalence. Today, leading regulatory authorities such as the FDA and EMA as well as the regulatory science community are aware of these challenges and discuss regulatory requirements. Particularly, demonstration of pharmaceutical equivalence and bioequivalence – prerequisites for generic approval according to Article 10(1) – is extremely difficult if not impossible. While nanomedicines share lots of communalities such as heterogeneity, complexity and the large molecular size with biologics, they are synthetic products and therefore, not eligible for article 10(4) biosimilar application either.PurposeHere we calculated the potential cost savings that can emerge from biosimilar-like pathways for nanosimilars that would provide regulatory clarity.Material and methodsThe estimation of potential savings on healthcare expenditure is based on a model of the forecasted year 2020 costs of the nanomedicines and the average decrease in price for biologics observed after the introduction of biosimilars. The model was applied to markets in five different EU countries (France, Germany, Italy, Spain and the UK, combined as EU-5) and in the US.ResultsThe predicted saving potentials for the EU-5 and the US in year 2020 are €280 million and $2 billion, respectively. In 2023, after expiry of the patents for ferric carboxymaltose and paclitaxel, additional savings of €84 million and $233 million can be expected.ConclusionThe biosimilar legislation that has successfully facilitated patient access to safe and cost-effective medicine could serve as a model for a yet-establish nanosimilar approval pathway. This pathway could provide a substantial saving potential to the healthcare systems.References and/or Acknowledgements1. Agüera ML, et al. PLOS One2015;10(8).2. Hussart L, et al. l Annal NYAS2017.Conflict of interestCorporate-sponsored research or other substantive relationships: *I am an employee of Vifor Pharma Ltd., a producer of intravenous nanomedicines.