Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework

Date/Time
Date(s) - 23 Jul 2013 until 23 Jul 2013
9:00 AM - 10:00 AM

Location


Preparing for Biosimilars:

Key Points for Participating in the U.S. Regulatory Framework

WEBINAR

In view of the U.S. approval process for biosimilars, companies are gearing up to either produce their own biosimilar products, or to defend against their entry onto the market. While the Biologics Price Competition and Innovation Act (BPCIA) spells out many of the requirements, the pathway for approval is  complicated. Our panel of experts will discuss the features of the BPCIA  and how it operates for both approved biologics as well as biosimilar  entrants. They will also make some predictions on its impact for life  science companies.


When: Tuesday, July 23,       2013
9:00 am PST | 12:00 noon EST
60 minutes, complete with Q&A

Sign Up Now!

One hour of California CLE credit available for attorneys.

Washington CLE credit pending.


 

What We Will Cover:

  • Overview of the BPCIA
  • Preparing for the Patent  Exchange
  • Strategic Use of AIA Post-Grant Procedures

Panel of Attorneys:

Michael Fuller
J.D. University of San Diego
M.S. Biology, University of California, Los Angeles
B.S. Biology, University of California, Los Angeles

Sheila Swaroop
J.D. University of California, Berkeley School of Law
B.A. Biology, Harvard University

Carol Pitzel Cruz
J.D. The George Washington University Law School
B.S. Chemistry, University of Washington

Eli Loots
J.D. University of California, Berkeley School of Law
Ph.D. Molecular and Cell Biology, University of California, Berkeley
B.S. Chemistry and Biochemistry, University of Arkansas

About Knobbe Martens

knobbe martensKnobbe Martens has one of the largest and most experienced biotechnology groups in IP law, with more than 75 attorneys and scientists representing clients in all stages of their business and technology development. We maintain a talented litigation group adept         in all aspects of biotechnology IP law. Our extensive Hatch-Waxman litigation practice combined with our deep technical expertise in biotechnology uniquely position Knobbe Martens to develop and implement  effective IP strategies for biosimilars.