Activity: Talk or presentation types › Lecture and oral contribution
Description
This session addresses corresponding biosimilar-related developments under US law and contrasts them with certain aspects under the European regime. Special emphasis will be laid on the new US Approval Pathway for Biosimilar Products and the specific data exclusivity provisions under the recently enacted Biologics Price Competition and Innovation Act of 2009 (BPCIA). Moreover, we will discuss the new FDA biosimilar guidelines implementing certain provisions of the BPCIA
Period
14 Aug 2008
Event title
Pharmaceutical Law & Policy- Hot topics shaping the future of the pharma industry: Copenhagen Summer University 2013