On-Demand   MP3 Audio
  Also Available in:  On-Demand Audio Only On-Demand Web

Are You Ready to Enter the U.S. Biosimilars Pathway?

Recorded on: Aug. 16, 2012
Running Time: 01:11:33

Taken from the briefing Are You Ready to Enter the U.S. Biosimilars Pathway? recorded August, 2012.

The U.S. Biosimilars legislation was signed into law in March 2010.  The FDA published draft Guidance documents to implement Biosimilars in the Spring of 2012.  With many biologic drugs poised to come off patent in the next few years, Biotech and Biosimilars companies are preparing to test the U.S. Biosimilars system.  Several 351(k) Biosimilars Applicants are currently engaged in pre-filing discussions with FDA.  Are you ready?  Listen in to hear a practical discussion of what you should be doing to get ready for U.S. Biosimilars.

Lecture Topics  [Total Time: 01:11:33]

  • When is a (k) applicant ready to contact the FDA?
  • What is needed to satisfy requirements and Totality of the Evidence approach for Biosimilarity? Interchangeability?
  • What should a potential Reference Product Owner do to prepare for Biosimilars?
  • What patent portfolio approaches might be taken to protect a Reference Product?
  • What strategies can help prepare for document exchange and Biosimilars litigation?

Presentation Material

  • Government Strategies Alert: FDA’s Draft Guidance on Scientific
    Donald R. Ware
  • Are You Ready to Enter the U.S. Biosimilars Pathway?
    Donald R. Ware
  • The FDA’s Proposed Biosimilar Approval Pathway Guidance Documents Scientific and Quality Considerations (and Q&A)
  • Guidance for Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 
  • Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  • Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
  • Are You Ready to Enter the U.S. Biosimilars Pathway?
Speaker(s)
Kurt R. Karst ~ Hyman, Phelps & McNamara, P.C.
Denise M. Kettelberger, Ph.D. ~ Faegre Baker Daniels LLP
D. Christopher Ohly ~ Schiff Hardin LLP
Donald R. Ware ~ Foley Hoag LLP

PLI makes every effort to accredit its recorded programs.


PLI MP3s are approved in the following states/territories: AK, CA1, CO, FL, GA, ID*, IL, KS2, ME, MO, MT, NC, ND, NH*, NJ, NM, NV, NY, OR*, PA, TX3, UT, VI, VT, WA, WV, WY. Some exceptions apply. For more information contact PLI.
 

1California: This activity qualifies for participatory credit.

2Kansas: There is a 5.0 credit limit per year for this type of viewing.

3Texas: Considered self-study credit.  There is a 5 credit limit, including specialty credit.

Please note: The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement.

*
PLI will apply for credit upon request.



Running time and CLE credit hours earned are not necessarily the same.
Please be aware that many states do not permit credit for luncheon speakers.

Special Note: In New York, non-traditional course formats including audio and video cassettes are NOT acceptable for transitional CLE credit for the newly admitted attorney within the first two years after their admission to the Bar. Attorneys other than newly admitted may use non-traditional course format, including audio and video cassettes to fulfill their CLE requirements.

IMPORTANT INFORMATION FOR ATTORNEYS SEEKING CLE CREDIT


While listening to the program, be alert to listen for the AUTHORIZATION CODE which has been placed somewhere within the program.  Write the code down; you will be asked for this information when you request CLE credit.
 
Once you’ve completed the program, please go to www.pli.edu and log in. Once you are logged in, your account will be displayed and the available programs will be listed on the left side under the heading "My Online Library".  If you are already logged in, click the link for My Account on the home page to access your Online Library.  Return to the program and click the MCLE Registration button in the top right region of the program window.  A new window will open with a CLE Request form, you will be asked to complete a short evaluation, and fill in the AUTHORIZATION CODE, please complete and submit the form.


Once you click the Submit button, your request for CLE credit will be sent to the CLE department.  PLI will email you a CLE certificate within 48 hours.


If you are unable to successfully log in, please contact our customer service department at 800-260-4754 for assistance.

GENERAL INFORMATION

This product is designed to provide practical and useful information on the subject matter covered.  However, it is sold with the understanding that the publisher is not engaged in rendering legal, accounting or other professional services.  If legal advice or other expert assistance is required, the services of a competent professional should be sought.


If you have already received credit for attending some or the entire program, please be aware that state administrators do not permit you to accrue additional credit for repeat viewing even if an additional credit certificate is subsequently issued.

Print Share Email