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Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
March 26-27, 2018 | Orlando, USA
World Summit on
Healthcare & Hospital Management
&
International Conference & Exhibition on
Biologics and Biosimilars
T
oday, 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. But upon substitution, significant differences
have been observed in clinical practice raising doubt about
their therapeutic equivalence. Today, leading regulatory
authorities such as 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 505(j), 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 the 505(k) biosimilar pathway. Hence,
today generic manufacturers seeking for regulatory approval of
follow-on products face challenges due to the nature of these
nanomedicines and lack of an appropriate regulatory pathway
following the principle of similarity. Based on data from the
introduction of biosimilars in Europe, we estimate potential
health care expenditure savings of EUR 280 million in France,
Germany, Italy, Spain and UK, and USD 2’002 million in the US
for the year 2020 from an approval pathway for nanosimilars.
The biosimilar legislation that has successfully facilitated patient
access to save and cost-effective medicine could serve as a
model for a yet to establish nanosimilar approval pathway.
Speaker Biography
B Flühmann is a Pharmacist by training and holds a PhD in Molecular Biology from
ETH Zürich, Switzerland on “Structural analysis and characterization of cell surface
receptors” and a MBA of the University of St. Gallen Switzerland. He is working in
various positions in the field of Pharmaceuticals and Functional Nutrition. He has
been leading a global multidisciplinary research and development team at Roche/DSM
nutritional products developing novel compounds for the prevention and treatment
of diabetes. At Vifor Pharma Ltd., he has been acting as Global Brand Director defining
global strategic product plans across all functions (medical, marketing, market research,
regulatory, life cycle management, logistics) and ensuring the operational execution. In
his current position at Vifor Pharma Ltd, he is Global Lead of Non-Biological Complex
Drugs with a main interest in regulatory aspects of nanomedicines. He is a Steering
Committee Member of the Non-Biological Complex Drugs Working Group hosted at
Lygature a non-for-profit organization. The mission of the Non-Biological Complex
Drugs Working Group is to work on appropriate and harmonized science-based
approval and post-approval standards for Non-Biological Complex Drugs to ensure
patient benefit and safety.
e:
Beat.Fluehmann@viforpharma.comBeat Flühmann
Vifor Pharma Ltd., Switzerland
Nanomedicines: An emerging regulatory challenge