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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
P
harmaceutical regulators have a dual responsibility.
On the one hand, they need to protect and promote
public health; while on the other hand, they have a role in
stimulating pharmaceutical innovation through scientific
advice, regulatory guidelines and other forms of regulatory
dialogue. Although regulators are acclaimed for their
scientific expertise and independence, they are also criticized
for being a source of bureaucracy and thus stifling innovation.
I will analyze the emergence of the EU biosimilar regulatory
framework and the need for biosimilar ambassadors within
hospitals. I demonstrate that in an uncertain environment,
European regulators have created a regulatory framework
for biosimilars that stimulates innovation while attempting
to maintain high safety standards. But, alignment with
doctors is essential in order to stimulate the cost-effective
application of biosimilars in clinical practice. This case study
provides valuable lessons on how to handle the biosimilar
challenges in a highly volatile pharmaceutical sector and
within a specific regulatory and healthcare framework.
e:
t.pieters@uu.nlBiosimilars and the management of double binds
Toine Pieters
Utrecht University, Netherlands