New FDA Guidelines & the MA pathway for Biosimilars in the US
Activity: Talk or presentation types › Lecture and oral contribution
Timo Minssen - Lecturer
- Faculty of Law Research Centres
- Centre for Information and Innovation Law
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
Event (Course)
Title | Pharmaceutical Law & Policy- Hot topics shaping the future of the pharma industry |
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Abbreviated title | CSU 2013 |
Date | 12/08/2013 → 16/08/2013 |
Location | Frederiksberg Campus |
City | Copenhagen |
Country/Territory | Denmark |
ID: 49702832