New FDA Guidelines & the MA pathway for Biosimilars in the US

Beskrivelse

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

Periode	14 aug. 2008
Begivenhedstitel	Pharmaceutical Law & Policy- Hot topics shaping the future of the pharma industry: Copenhagen Summer University 2013
Begivenhedstype	Kursus
Placering	Copenhagen, DanmarkVis på kort