healthcare-biosimilars-2018-keynote

Page 36

Notes:

allied

academies

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

Aaron Damien Barzey

ADB Medical, United Kingdom

EU biosimilar regulation and the possible effect of Brexit on biosimilar medicines

he European Union (EU) has led the way for the global

expansion of the biosimilar market for 15 years and is the

global leader in the review and approval of biosimilar medicines

and biosimilar regulation via the London based European

Medicines Agency (EMA). Other countries, such as Australia,

work side by side with the regulations and guidance produced

from the EMA, and institutions, such as the World Health

Organisation, have periodic meetings in London to discuss

biosimilar medicines. Because, the United Kingdom is about to

leave the EU on 29

March 2019 and the EMA and all its staff

will have to relocate to remain in the EU as a result. All biosimilar

products will need to be re-registered to one of the remaining

27 countries and there is the very real risk that this relocation

will see losses in talented staff as well as hinder the approval

and maintenance of biosimilar medicines.

Speaker Biography

Aaron Damien Barzey has been working in the Pharmaceutical Industry, covering

Medical Affairs, Pharmacovigilance, Regulatory Affairs and Compliance, in multiple

countries and multiple companies. At GSK, he was the Global Labelling Lead for the

orphan drug ‘ofatumumab’. He was responsible for the company core datasheets,

labelling strategy, EU labelling negations and oversaw the product launch in emerging

markets. His major accomplishment was leading the launch of Arzerra for the

treatment of chronic lymphatic leukaemia across the EU, Australia and other countries.

In 2015, he started his own regulatory consultancy, ADB Medical, providing ad-hoc

support or project specific guidance to various companies. In 2016, he was chosen

as the Pharmaceutical Industry SME to discuss the possible impact of Brexit on the

pharmaceutical industry, which included debating with Nigel Farage live on national

television and to discuss further on live on UK TV with Piers Morgan and Susanna Reid.