Biosimilars: Current Framework and Future Directions

Biosimilars: Current Framework and Future Directions CLE sponsored by the Biotech/Chem Law Committee of the Minnesota Intellectual Property Law Association (MIPLA)

WHEN: Thursday, October 21, 2010 from Noon to 1:00 p.m.

SPEAKERS : Brian R. Dorn, Ph.D. and Katherine M. Kowalchyk, Ph.D.

TOPIC: Biosimilars

This presentation will address the current legislation regarding biosimilars and the future directions of the FDA's approval process. First, the presenters will review the current approval pathway and litigation scheme from the Biologics Price Competition and Innovation (BPCI) Act of 2010. Then there will be a discussion of issues pertaining to the FDA's implementation of the pathway to approve biosimilars and strategic ramifications of the passed legislation and FDA requirements.

WHERE: Merchant & Gould, P.C., Boardroom, 3200 IDS Center, 80 South Eighth Street, Downtown Minneapolis from 12:00 a.m. to 1:00 p.m.

TELECONFERENCING: If you cannot attend this meeting in person but would like to participate via the phone, here are the instructions:

Dial-In Number is 1-800-322-6091

Passcode is 7099 422#

BRING: A bag lunch. We will supply beverages.

1 credit of CLE (Minnesota) will be applied for. There is no fee to attend.