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

Aktivitet: Tale eller præsentation - typerForedrag og mundtlige bidrag

Timo Minssen - Foredragsholder

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
15 aug. 2012

Begivenhed (Kursus)

TitelPharmaceutical Law & Policy- Hot topics shaping the future of the pharma industry
Forkortet titelCSU
AfholdelsesstedUniversity of Copenhagen, Frederiksberg Campus

ID: 40317344