Making Sense of FDAâ€™s (proposed) Rules for the Development and Approval of Biosimilars (Biotech Training)
Venue: Online Event
|Event Date/Time: Jul 25, 2012||End Date/Time: Jul 25, 2012|
Why Should You Attend:
On February 9, 2012, the U.S. Food and Drug Administration (â€œFDAâ€ or â€œAgencyâ€) released three highly anticipated guidance documents designed to answer industry questions regarding the development and approval of biosimilars (a/k/a follow-on biologics). The guidance documents provide specific advice and recommendations on steps applicants can take to obtain approval of a proposed biologic product under FDAâ€™s proposed abbreviated approval pathway.
The Biologics Price Competition and Innovation Act of 2009 (â€œBPCIAâ€) amended the Public Health Service Act by adding Section 351(k) which created an abbreviated approval pathway for biological products that are found to be â€œhighly similarâ€ or â€œinterchangeableâ€ with a reference biological product (e.g., vaccines, antibodies, blood and blood components, gene therapies, tissues, and proteins) that have already been approved or â€œlicensed.â€