FDA public hearing for biosimilar guidelines

March 5, 2012 8:01 AM

The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain input on recently issued draft guidances relating to the development of biosimilar products (draft guidances). 

These draft guidances were issued by FDA as part of the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

The BPCI Act establishes an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to, or interchangeable with, a reference product.  FDA will consider the information it obtains from the public hearing in the finalization of these guidances.  In addition, FDA is soliciting public input regarding topics for future policies regarding biosimilars.

Date:        May 11, 2012
Time:        8:30 a.m. to 5:00 p.m.
Location:  FDA White Oak Campus

Source: FDA

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)

Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?


Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!