WHO: BQ Scheme Can Align With FDA Suffix As Long As It Remains Random

February 5, 2016 at 2:29 PM
The World Health Organization says there is a way to combine its newly unveiled biosimilar naming approach, which relies on biological qualifiers, with the divergent approach pushed by FDA: If a company is first provided an FDA suffix for their biological product, that code could be added to the Biological Qualifier database and then applied when a qualifier is requested for the same drug substance. Alliance for Safe Biologic Medicines Executive Director Michael Reilly says WHO is seeking as much...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.