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

Aktivitet: Tale eller præsentation - typerForedrag og mundtlige bidrag

Timo Minssen - Foredragsholder

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
14 aug. 2008

Begivenhed (Kursus)

TitelPharmaceutical Law & Policy- Hot topics shaping the future of the pharma industry
Forkortet titelCSU 2013
AfholdelsesstedFrederiksberg Campus

ID: 49702832