FDA releases draft guidance on determining exclusivity period for biologics

NEW YORK — The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported. 

 

According to the report, the agency is reviewing options for making information publicly available regarding reference product exclusivity and dates of first licensure. 

 

Approval of a 351(k) application may not take effect until 12 years after the date of first licensure of the reference product. A 351(k) application for a biosimilar or interchangeable biological product cannot be submitted for review until four years after the date on which the reference product was first licensed.