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Nanosimilars: A Scientific or A Regulatory Debate?
Costas Demetzos1,2,3
1School of Health Sciences, Department of Pharmacy, Section of Pharmaceutical Technology, Laboratory of Pharmaceutical Nanotechnology, National & Kapodistrian University of Athens, Athens, Greece. demetzos@pharm.uoa.gr.
Establishing a regulatory framework for nanomedicines and nanosimilars is crucial. This involves defining similarity criteria for nanocarriers and fostering collaboration for safe and effective therapeutic advancements.
Area of Science:
- Nanomedicine
- Regulatory Science
- Pharmaceutical Sciences
Background:
- Nanomedicines offer therapeutic potential but require robust regulatory oversight.
- Off-patent nanomedicines, termed nanosimilars, necessitate clear similarity criteria for approval.
- Nanocarriers, as advanced self-assembled excipients (ASAEs), exhibit complex behavior demanding precise evaluation.
Purpose of the Study:
- To highlight the need for a comprehensive regulatory framework for nanomedicines and nanosimilars.
- To define essential criteria for establishing 'similarity' between nanomedicines and nanosimilars.
- To emphasize the role of interdisciplinary collaboration in nanomedicine development and regulation.
Main Methods:
- Review of existing regulatory approaches for complex medicines.
- Analysis of key physicochemical, thermodynamic, morphological, and biological properties of nanocarriers.
- Exploration of artificial intelligence (AI) applications in nanomedicine characterization.
Main Results:
- A robust regulatory framework must define similarity based on nanocarrier properties and pharmacokinetics.
- Characterization of nanocarriers requires evaluation of their complex and chaotic behavior.
- Collaboration between industry, regulators, and AI startups is vital for efficient approval processes.
Conclusions:
- Developing a sustainable regulatory framework for nanomedicines and nanosimilars is essential for ensuring safety and efficacy.
- Embracing innovative tools and terminology, including AI, will facilitate precision R&D.
- This approach supports therapeutic advancements and economic benefits in the pharmaceutical sector.
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