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

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