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Nanomedicines: The magic bullets reaching their target?

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Summary

Assessing nanomedicine similarity is challenging due to complex physicochemical properties. Developing harmonized regulatory pathways and education is crucial for safe and effective nanosimilars.

Keywords:
EMAEuropean Federation for Pharmaceutical Sciences (EUFEPS)NanomedicinesNanosimilarNon-biological complex drugs (NBCDs)Regulatory science

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Area of Science:

  • Pharmaceutical Sciences
  • Nanotechnology
  • Drug Development

Background:

  • Nanomedicines offer potential for higher efficacy but face challenges due to complexity.
  • Understanding nanomedicine interactions with biological systems is limited.
  • Physicochemical characterization of nanomedicines is difficult due to size and surface properties.

Purpose of the Study:

  • To review the challenges in assessing nanomedicine and nanosimilar similarity.
  • To discuss regulatory aspects and practical considerations for nanomedicines and nanosimilars.
  • To highlight the impact of nanosize properties on critical quality attributes and bioequivalence.

Main Methods:

  • Review of discussions from the EUFEPS Nanomedicine Network session.
  • Analysis of challenges in physicochemical characterization.
  • Examination of regulatory evaluation procedures and educational needs.

Main Results:

  • Nanosize and surface properties complicate physicochemical characterization and similarity assessment.
  • Lack of harmonized regulatory procedures hinders nanosimilar development.
  • Uncertainty in practical use and higher healthcare costs are linked to insufficient safe and efficacious nanosimilars.

Conclusions:

  • Establishing critical quality attributes and demonstrating bioequivalence for nanosimilars requires addressing nanosize-related properties.
  • Development of harmonized regulatory frameworks and education is essential for advancing nanomedicine.
  • Improved assessment methodologies are needed to ensure the availability of safe and effective nanosimilars.