Stefan Mühlebach, University of Basel (Switzerland)
I’m Stefan Mühlebach, Prof. em. in Pharmacology and Hospital Pharmacy at the University of Basel in Switzerland. Due to my activity in nanopharmaceutical and regulatory science, I was a founding member of the Non-Biological Complex Drugs working party in the Netherland more the 10 years ago.
Nanotechnology allows to better target eventually drug action sites and to innovate therapies.
Such NBCDs with nano characteristics are manufactured by complicated and difficult to control procedures, also responsible for CQA. PE and BE of follow-on products, the nanosimilars, are difficult to show as they cannot be fully characterized by physicochemical analyses; CQA are often unknown or not defined. A different biodistribution does not allow a classical BE approach.
There is no harmonized definition of nanopharmaceuticals nor a well-defined authorization pathway for nanosimilars. No consent exists how to substitute or interchange such products.
The advances and challenges of nanotechnology to overcome barriers given by classical drugs, will be addressed in my talk at the Geneva workshop in April 2021