The Approval of Biosimilars in the US – novel guidelines and developments

Beskrivelse

Biosimilars in the US

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.


A presentation given at a 5 days intensive training for practitioners/professionals in Pharma Law & Policy (CSU), 13 – 17 August 2012, 9, at the University of Copenhagen, Frederiksberg Campus

Periode	15 aug. 2012
Begivenhedstitel	Pharmaceutical Law & Policy- Hot topics shaping the future of the pharma industry: Copenhagen Summer University
Begivenhedstype	Kursus
Placering	Copenhagen, DanmarkVis på kort